Mutual Recognition of the Food and Drug Administration and European Community Member State Conformity Assessment Procedures; Pharmaceutical GMP Inspection Reports, Medical Device Quality System Evaluation Reports, and Certain Medical Device Premarket Evaluation Reports

Federal RegisterApr 10, 1998

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 26

[Docket No. 95N-0185]

RIN 0910-ZA11

Mutual Recognition of the Food and Drug Administration and

European Community Member State Conformity Assessment Procedures;

Pharmaceutical GMP Inspection Reports, Medical Device Quality System

Evaluation Reports, and Certain Medical Device Premarket Evaluation

Reports

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend

its regulations pursuant to an international agreement that is expected

to be concluded between the United States and the European Community

(EC) (Ref. 1). Under the terms of that agreement, FDA may normally

endorse good manufacturing practice (GMP) inspection reports for

pharmaceuticals provided by equivalent EC Member State regulatory

authorities and medical device quality system evaluation reports and

certain medical device premarket evaluation reports provided by

equivalent conformity assessment bodies. FDA is taking this action to

enhance its ability to ensure the safety and efficacy of

pharmaceuticals and medical devices through more efficient and

effective utilization of its regulatory resources. The agency is

requesting comments on the proposed rule.

DATES: Comments by May 11, 1998. Comments must be received by the

Dockets Management Branch (address below) by 4:30 p.m. Eastern Standard

Time on May 11, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857, fax 301-594-3215.

FOR FURTHER INFORMATION CONTACT: Merton V. Smith, Office of

International Affairs (HFG-1), Office of External Affairs, Food and

Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-

0910, or E-mail: ``MS[email protected]''.

SUPPLEMENTARY INFORMATION:

I. Background and History

On June 20, 1997, the United States and the EC concluded

negotiations of an agreement entitled ``Agreement on Mutual Recognition

between the United States of America and the European Community'' (also

called ``the MRA''). The MRA includes two sectoral annexes covering

products regulated by FDA. The medical device sectoral annex covers

medical device quality system-related inspection reports and premarket

evaluation reports. The pharmaceutical GMP sectoral annex covers

pharmaceutical GMP inspection reports. The MRA also includes sectoral

annexes covering products regulated by other U.S. regulatory agencies,

including telecommunication equipment, electromagnetic compatibility,

electrical safety, and recreational craft. Finally, the MRA includes an

``umbrella'' agreement that contains general provisions applicable

[[Page 17745]]

to the operation of all of the sectoral annexes.

At the conclusion of negotiations, the United States and the EC

agreed to submit the text of the MRA to their respective authorities to

complete the necessary procedures for approval and implementation (Ref.

2). For FDA, the procedures include publishing this proposed rule for

public comment.

In this document, FDA has published relevant provisions of the two

FDA sectoral annexes and the umbrella agreement, some of which create

binding obligations. FDA will review all comments and will consider

those comments addressing its binding obligations under the agreement.

II. Statutory Authority

FDA has the authority to enter into and execute the MRA under the

Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321 et seq.)

and the Public Health Service Act (the PHS Act) (42 U.S.C. 201 et

seq.). For drugs and medical devices, section 510(i)(3) of the act (21

U.S.C. 360(i)(3)) provides authority for FDA to enter into the MRA.

Section 510(i)(3) of the act provides that:

The Secretary [FDA by delegation] is authorized to enter into

cooperative arrangements with officials of foreign countries to

ensure that adequate and effective means are available for purposes

of determining, from time to time, whether drugs or devices

manufactured, prepared, propagated, compounded, or processed by an

establishment * * * [described in this section], if imported or

offered for import into the United States, shall be refused

admission on any of the grounds set forth in section 801(a).

(Ref. 3).

The MRA and the pharmaceutical and medical device annexes represent

cooperative arrangements with officials from foreign countries. The

purpose of these arrangements is, among other things, to ensure FDA has

adequate and effective means to determine whether drugs or devices

offered for import are adulterated, misbranded, or in violation of

section 505 of the act (21 U.S.C. 355) (Ref. 4). FDA's authority to

make these determinations is found at section 801(a) of the act (21

U.S.C. 381(a)).

Section 803(b) of the act (21 U.S.C. 383(b)) provides FDA with

authority to enter into the medical device sectoral annex. That section

authorizes FDA to enter into agreements with foreign countries to

facilitate commerce in medical devices, consistent with the provisions

of the act. Such agreements are to encourage the mutual recognition of

GMP regulations relating to devices, as well as other regulations and

testing protocols determined by the Secretary (FDA by delegation) to be

appropriate.

Additional support for FDA authority to enter into this MRA is

found in the PHS Act. Under section 307 of the PHS Act (42 U.S.C.

242l), the Secretary of Health and Human Services (FDA by delegation)

has authority ``to participate with other countries in cooperative

endeavors'' in biomedical research and health care technology. In

addition, the Secretary of Health and Human Services (FDA by

delegation) has authority under section 301 of the PHS Act (42 U.S.C.

241) to ``cooperate with, and render assistance to other appropriate

public authorities * * * in the conduct of * * * investigations * * *

relating to the * * * prevention of physical and mental diseases and

impairments of man * * * .'' The cooperative activities between FDA and

the EC set forth in the MRA and this proposed regulation, fall within

FDA's delegated authority under these sections of the PHS Act.

Finally, a provision of the recently enacted FDAMA provides

authority for FDA to participate in MRA activities. Section 410 of

FDAMA authorizes FDA to ``support the Office of the United States Trade

Representative, in consultation with the Secretary of Commerce, in

efforts to move toward the acceptance of mutual recognition agreements

relating to the regulation of drugs, biological products, [and] devices

* * * and the regulation of good manufacturing practices, between the

European Union and the United States'' (Ref. 5). During negotiation of

this MRA, officials from FDA, the Office of the United States Trade

Representative, and the Department of Commerce participated in

activities in an effort to move toward acceptance of a mutual

recognition agreement.

III. Environmental Impact

The agency has determined under 21 CFR 25.30(h) that this action is

of a type that does not individually or cumulatively have a significant

effect on the human environment. Therefore, neither an environmental

assessment nor an environmental impact statement is required.

IV. Analysis of Impacts

FDA has examined the impacts of the proposed rule under Executive

Order 12866, under the Regulatory Flexibility Act (Pub. L. 96-354, as

amended by Pub. L. 104-121), and under the Unfunded Mandates Reform Act

(Pub. L. 104-4). Executive Order 12866 directs agencies to assess all

costs and benefits of available regulatory alternatives and, when

regulation is necessary, to select regulatory approaches that maximize

net benefits (including potential economic, environmental, public

health and safety, and other advantages; distributive impacts; and

equity). The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities. The Unfunded Mandates Reform Act requires agencies

to prepare an assessment of anticipated costs and benefits before

enacting any rule that may result in an expenditure by State, local and

tribal governments, in the aggregate, or by the private sector, of

$100,000,000 (adjusted annually for inflation) in any one year.

The agency believes that this proposed rule is consistent with the

regulatory philosophy and principles identified in the Executive Order

and in these two statutes. Through this regulation, the agency is

proposing to set out requirements through which it may normally endorse

certain conformity assessment procedure reports. Such reports would be

provided by equivalent EC Member State regulatory authorities for

manufacturing site inspections to ascertain conformity with

pharmaceutical GMP's and by equivalent conformity assessment bodies for

quality system audits and certain medical device premarket evaluations.

Obtaining conformity assessment information in the manner described in

the proposed rule is inherently more efficient and cost-effective than

the existing approach, where additional inspection efforts by FDA in

foreign countries are necessary because foreign regulatory systems have

not been found equivalent. The primary benefit of the proposed rule is

to provide credible assurance that the rapidly increasing volume of EC

Member States' imports into the United States meet pharmaceutical GMP

requirements, and medical device quality system evaluation and certain

premarket evaluation requirements, as specified in U.S. statutes and

regulations. In the future, this credible assurance must be achievable

without resource expenditures by FDA that are directly proportional to

the volume of trade.

In recent years, the credibility of the current approach has been

strained as FDA's essentially constant foreign inspection capacity has

been stretched over an expanding volume of imports from the EC. In the

3-year interval between 1994 and 1997, the value of EC pharmaceutical

and medical device imports into the United States has nearly doubled

from $5.5 billion to more than $10.7 billion. Growth has been greatest

in pharmaceuticals, where

[[Page 17746]]

annual EC exports have increased by more than $2 billion in each of the

last 2 years. In 1997, FDA conducted one inspection in the EC for every

$60 million in pharmaceutical exports to the United States, which is

less than half the coverage intensity of 1994. In addition, the

majority of these inspections have been preapproval in nature.

Continuation of the current trend will further decrease FDA's coverage

intensity to less than one inspection per $100 million in EC

pharmaceutical exports by the year 2000. Equivalence with EC Member

State regulatory systems has the potential for leveraging FDA's

regulatory resources so that necessary conformity assessments can be

ensured for higher volumes of future trade.

In addition to coping with higher trade volumes, mutual recognition

or equivalence-based agreements with exporting nations may permit FDA

to redirect some of its inspectional resources to risk priorities not

covered by such agreements. This flexibility would provide a more

responsive level of U.S. consumer protection in the face of a changing

global marketplace with inherently variable risk management priorities.

Another important benefit of the proposed rule would be the cost

savings realized by the regulated industry, largely as a result of

sharing inspection reports among equivalent regulatory authorities.

This exchange, in turn, will eliminate the need for duplicative

inspections and permit individual firms to undergo fewer inspections of

manufacturing sites. FDA does not have data on the average

administrative cost incurred by pharmaceutical (including biological)

or medical device manufacturers as they participate in regulatory

inspections, but it is reasonable to assume that the avoidance of

redundant inspections would generate cost savings. The proposed rule

also may shorten product review times for regulated products as a

result of the increased efficiency of premarket approval inspection

activities and the third-party evaluation of certain medical devices.

Quantification of this savings will be highly dependent on the specific

countries that achieve equivalence and the number of medical device

audits and evaluations performed by conformity assessment bodies.

The costs of this regulation appear to impact more directly on

governmental regulatory agencies than on the regulated industry. These

governmental costs involve both startup and operational components. FDA

has not received additional government funding earmarked for achieving

mutual recognition agreements. FDA, therefore, must proceed to

implement these agreements as a concurrent function within normal day-

to-day regulatory activities. The 3-year transition period reflects the

necessity to absorb these startup costs within existing regulatory

budgets. Some activities such as joint inspections may be reasonably

easy to absorb as concurrent functions that do not require additional

funding, while others such as developing and maintaining systems for

routine information exchange may involve new activities. These absorbed

governmental costs will fall heavily on FDA, as it must assess

equivalence of multiple EC Member States and notified bodies.

For FDA, the absorption of these startup costs will be easier with

respect to those EC Member States with a large volume of trade, where

FDA already conducts enough inspections to gather a general

understanding of the requirements and regulatory practices of the

exporting country. From this perspective, the pace and priorities for

mutual recognition agreements during the transition period may be

dictated by FDA's ability to conduct these processes as concurrent

functions within current activities.

In the longer run, an operational system of mutual recognition

agreements could pose additional costs on regulatory authorities of

exporting countries if equivalence requires a frequency, focus or

content of inspections not presently included in regulatory

requirements of the exporting nation. For example, Country A may not be

able to provide the frequency of medical device inspections desired by

Country B without conducting inspections beyond those required for

Country A's domestic inspection strategy. Conversely, Country B may not

be able to provide to Country A adequate details of the quality of

pharmaceutical source materials, because Country B does not have

inspectional authority over pharmaceutical starting materials. To the

extent such costs are insignificant or offset by other savings, they

will not likely be obstacles to reaching agreement on equivalence.

This proposal is not expected to involve any new incremental costs

to the affected industry. Although joint inspections during the

transition period may create the appearance of more regulatory effort,

they should not impose additional costs on the firms inspected. FDA

does not anticipate an increase in the total number of inspections, and

in fact, the coverage intensity of FDA inspections in the EC would

continue to fall during the transition period, as it has been for the

past several years. Other activities related to equivalence

determinations, such as the procedures for exchanging information and

reports, focus on the interface and coordination between regulatory

agencies and, as such, do not affect industry in a cost context.

The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities unless the rule is not expected to have a significant

impact on a substantial number of small entities. As the proposed

regulation is not expected to impose costs on the regulated industry,

the agency certifies that the proposed rule would not have a

significant impact on a substantial number of small entities.

Therefore, under the Regulatory Flexibility Act, no further analysis is

required.

The Unfunded Mandates Act of 1995 requires that agencies prepare an

assessment of the anticipated costs and benefits before issuing any

final rule that may result in expenditures by State, local, and tribal

governments, in the aggregate, or by the private sector, of

$100,000,000 or more (adjusted annually for inflation) in any one year.

This proposed rule does not impose any mandates on State, local or

tribal governments, or the private sector that would result in an

annual expenditure of $100,000,000 or more. Therefore, no further

analysis is appropriate for this requirement.

V. Paperwork Reduction Act of 1995

This proposed rule does not contain any information collection

provisions that would be subject to review by the Office of Management

and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C.

3501-3520).

VI. Request for Comments

Interested persons may, on or before May 11, 1998, submit to the

Dockets Management Branch (address above) written comments regarding

this proposed regulation. Comments must be received by the Dockets

Management Branch by 4:30 p.m. Eastern Standard Time May 11, 1998. Two

copies of any comments are to be submitted, except that individuals may

submit one copy. Comments are to be identified with the docket number

found in brackets in the heading of this document. Received comments, a

copy of the MRA, and a summary explanation of the MRA's provisions, to

aid in commenting, may be seen in the office above between 9 a.m. and 4

p.m., Monday through Friday. In addition, an electronic copy of the MRA

and the summary

[[Page 17747]]

explanation is available on FDA's web site at ``http://www.fda.gov''

under the ``international'' heading menu item.

The comment period in this document is shorter than the 60 days FDA

customarily provides for proposed rules (21 CFR 10.40(b)(2)). FDA

believes it is unnecessary to provide 60 days for comment, given the

opportunities for public comment the agency already has provided.

During the course of the negotiations of the MRA, FDA provided a number

of opportunities for public discussion. For example, on May 9, 1996 (61

FR 21194), FDA established a public docket for information concerning

the MRA (Ref. 6). In addition, on October 18, 1996, FDA made available

for public comment copies of a document entitled, ``FDA Proposal for an

Agreement With the European Union Concerning the Mutual Recognition of

Inspections to Determine Adherence to Manufacturing Practices for

Pharmaceuticals Including Biologicals.'' FDA formally sought public

comment on this proposal through a Federal Register notice (61 FR

54448, October 18, 1996). To provide opportunity for public input into

the pharmaceutical GMP discussions with the European Commission, FDA

hosted public exchange meetings in Washington, DC, and Rockville, MD,

on March 31, 1995 (see 60 FR 15934, March 28, 1995), and October 30,

1996 (see 61 FR 54448, October 18, 1996). On November 8 and 9, 1996, a

transatlantic business dialogue (TABD) meeting included an extensive

discussion of the unresolved issues for the pharmaceutical and medical

device annexes to the MRA (Ref. 7), and on March 14, 1997, FDA

participated in a meeting of U.S. agencies and nongovernmental

organizations, which included several consumer, industry, and

environmental groups. Finally, FDA provided information and solicited

comment on the MRA at a September 23, 1997, National Consumer Forum

held in Washington, DC. The purpose of the forum was to facilitate

dialogue on the MRA between FDA and consumers.

In light of the extensive opportunities for public participation,

FDA believes there is good cause to provide 30 days for comment on this

proposed rule. The agency also believes it is in the public interest to

proceed expeditiously to implement the MRA, so that it can proceed

toward the anticipated resource efficiencies and enhancement of product

safety, effectiveness, and quality that the MRA can provide. The 30-day

comment period provides sufficient opportunity to receive and consider

comments before the anticipated signing of the MRA in late spring or

early summer.

The agency also notes that the comment period is less than that

required by Executive Order 12889 (58 FR 69681, December 30, 1993).

Section 4 of Executive Order 12889 states that any agency subject to

the Administrative Procedure Act shall provide a 75-day comment period

for any proposed technical regulation. Because this proposed rule

creates no new technical obligations or mandatory requirements on the

public, FDA believes that it is not a technical regulation subject to

Section 4 of Executive Order 12889. As a result, a 75-day comment

period is not required for this proposed rule.

VII. References

1. The European Community consists of the following member

States: Austria, Belgium, Denmark, Finland, France, Germany, Greece,

Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain,

Sweden, and the United Kingdom. These countries have vested in the

European Commission the authority to conduct certain international

negotiations, on their behalf, with other countries such as the

United States.

2. On June 20, 1997, U.S. Trade Representative Charlene

Barshefsky and European Commission Vice President Leon Brittan

signed ``Agreed Minutes on the Agreement on Mutual Recognition

between the United States of America and the European Community,''

which states that the MRA ``represents the text we commit to submit

to our respective authorities with a view to completing the

necessary procedures for approval and implementation.'' The complete

text of the MRA is available on the Internet at FDA's web site,

``http://www.fda.gov'', under the ``international'' menu item or on

the European Community web site, ``http://europa.eu.int/en/comm/

dg01/mra03.htm''.

3. Food and Drug Administration Modernization Act of 1997

(FDAMA), section 417, Pub. L. 105-115, 111 Stat. 2296 (1997) (to be

codified at 21 U.S.C. 360(i)(3)).

4. Provisions in the act that govern FDA regulation of

pharmaceuticals and medical devices include sections 501, 502, 505,

512, 513, 520, and 522 (21 U.S.C. 351, 352, 355, 360b, 360c, 360j,

and 360l).

5. FDAMA section 410 (to be codified at 21 U.S.C. 383(c)(2)).

6. Information in the docket includes summaries of minutes of

the meetings described in this document with written comments

received from interested parties, summaries of the various

negotiation sessions between FDA and the European Commission and EC

Member State representatives, and copies of draft agreements

covering pharmaceutical GMP's and medical devices that were

exchanged between the EC and FDA in December 1996 and January 1997.

7. The TABD is an industry-driven initiative that aims to

facilitate closer economic relations between the EC and the United

States.

VIII. Comparison Table

The following table shows the relationship of the MRA Articles and

the sections of the Code of Federal Regulations (CFR) as proposed under

this rule:

Table 1.--Relationship of the MRA Articles to sections in the CFR

------------------------------------------------------------------------

MRA Article CFR Section

------------------------------------------------------------------------

Sectoral Annex for Pharmaceutical GMP's Subpart A

------------------------------------------------------------------------

Article 1................................. 26.1

Article 2................................. 26.2

Article 3................................. 26.3

Article 4................................. 26.4

Article 5................................. 26.5

Article 6................................. 26.6

Article 7................................. 26.7

Article 8................................. 26.8

Article 9................................. 26.9

Article 10................................ 26.10

Article 11................................ 26.11

Article 12................................ 26.12

Article 13................................ 26.13

Article 14................................ 26.14

Article 15................................ 26.15

Article 16................................ 26.16

Article 17................................ 26.17

Article 18................................ 26.18

Article 19................................ 26.19

Article 20................................ 26.20

Article 21................................ 26.21

Appendix 1................................ Appendix A

Appendix 2................................ Appendix B

Appendix 3................................ Appendix C

Appendix 4................................ Appendix D

Appendix 5................................ Appendix E

------------------------------------------------------------------------

MRA Article CFR Section

------------------------------------------------------------------------

Sectoral Annex on Medical Devices Subpart B

------------------------------------------------------------------------

Article 1................................. 26.31

Article 2................................. 26.32

Article 3................................. 26.33

Article 4................................. 26.34

Article 5................................. 26.35

Article 6................................. 26.36

Article 7................................. 26.37

Article 8................................. 26.38

Article 9................................. 26.39

Article 10................................ 26.40

Article 11................................ 26.41

Article 12................................ 26.42

Article 13................................ 26.43

Article 14................................ 26.44

Article 15................................ 26.45

Article 16................................ 26.46

Article 17................................ 26.47

Article 18................................ 26.48

Article 19................................ 26.49

Article 20................................ 26.50

Appendix 1................................ Appendix A

[[Page 17748]]

Appendix 2 and Tables 1-3................. Appendix B and Tables 1-3

Appendix 3 [Reserved]..................... Appendix C [Reserved]

Appendix 4 [Reserved]..................... Appendix D [Reserved]

Appendix 5 [Reserved]..................... Appendix E [Reserved]

Appendix 6 [Reserved]..................... Appendix F [Reserved]

------------------------------------------------------------------------

MRA Article CFR Section

------------------------------------------------------------------------

Umbrella Agreement Subpart C

------------------------------------------------------------------------

Article 1................................. 26.60

Article 2................................. 26.61

Article 3................................. 26.62

Article 4................................. 26.63

Article 5................................. 26.64

Article 6................................. 26.65

Article 7................................. 26.66

Article 8................................. 26.67

Article 9................................. 26.68

Article 10................................ 26.69

Article 11................................ 26.70

Article 12................................ 26.71

Article 13................................ 26.72

Article 14................................ 26.73

Article 15................................ 26.74

Article 16................................ 26.75

Article 17................................ 26.76

Article 18................................ 26.77

Article 19................................ 26.78

Article 20................................ 26.79

Article 21................................ 26.80

Article 22................................ 26.81

------------------------------------------------------------------------

List of Subjects in 21 CFR Part 26

Animal and human drugs, Biologicals, Devices, Exports, Imports,

Incorporation by reference, and Inspections.

Therefore, under the Federal Food, Drug, and Cosmetic Act and the

Public Health Service Act and under authority delegated to the

Commissioner of Food and Drugs, it is proposed that 21 CFR chapter I be

amended by adding part 26 to read as follows:

PART 26--MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING

PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND

CERTAIN MEDICAL DEVICE PREMARKET EVALUATION REPORTS PROVIDED BY

EUROPEAN COMMUNITY MEMBER STATE REGULATORY AUTHORITIES AND EUROPEAN

COMMUNITY CONFORMITY ASSESSMENT BODIES

Sec.

26.0 General.

Subpart A--Specific Sector Provisions for Pharmaceutical Good

Manufacturing Practices

26.1 Definitions.

26.2 Purpose.

26.3 Scope.

26.4 Product coverage.

26.5 Length of transition period.

26.6 Equivalence assessment.

26.7 Participation in the equivalence assessment and determination.

26.8 Other transition activities.

26.9 Equivalence determination.

26.10 Regulatory authorities not listed as currently equivalent.

26.11 Start of operational period.

26.12 Nature of recognition of inspection reports.

26.13 Transmission of postapproval inspection reports.

26.14 Transmission of preapproval inspection reports.

26.15 Monitoring continued equivalence.

26.16 Suspension.

26.17 Role and composition of the Joint Sectoral Committee.

26.18 Regulatory collaboration.

26.19 Information relating to quality aspects.

26.20 Alert system.

26.21 Safeguard clause.

Appendix A of Subpart A--List of Applicable Laws, Regulations, and

Administrative provisions.

Appendix B of Subpart A--List of Authorities.

Appendix C of Subpart A--Indicative List of Products Covered by

Subpart A.

Appendix D of Subpart A--Criteria for Assessing Equivalence for

Post- and Preapproval.

Appendix E of Subpart A--Elements to be Considered in Developing a

Two-way Alert System.

Subpart B--Specific Sector Provisions for Medical Devices

26.31 Purpose.

26.32 Scope.

26.33 Product coverage.

26.34 Regulatory authorities.

26.35 Length and purpose of transition period.

26.36 Listing of CAB's.

26.37 Confidence building activities.

26.38 Other transition period activities.

26.39 Equivalence assessment.

26.40 Start of the operational period.

26.41 Exchange and endorsement of quality system evaluation reports.

26.42 Exchange and endorsement of product evaluation reports.

26.43 Transmission of quality system evaluation reports.

26.44 Transmission of product evaluation reports.

26.45 Monitoring continued equivalence.

26.46 Listing of additional CAB's.

26.47 Role and composition of the Joint Sectoral Committee.

26.48 Harmonization.

26.49 Regulatory cooperation.

26.50 Alert system and exchange of postmarket vigilance reports.

Appendix A of Subpart B--Relevant Legislation, Regulations and

Procedures

Appendix B of Subpart B--Scope of Product Coverage

Appendix C of Subpart B [Reserved]

Appendix D of Subpart B [Reserved]

Appendix E of Subpart B [Reserved]

Appendix F of Subpart B [Reserved]

Subpart C--Framework or ``Umbrella'' Provisions

26.60 Definitions.

26.61 Purpose of this part.

26.62 General obligations.

26.63 General coverage of this part.

26.64 Transitional arrangements.

26.65 Designating authorities.

26.66 Designation and listing procedures.

26.67 Suspension of listed conformity assessment bodies.

26.68 Withdrawal of listed conformity assessment bodies.

26.69 Monitoring of conformity assessment bodies.

26.70 Conformity assessment bodies.

26.71 Exchange of information.

26.72 Sectoral contact points.

26.73 Joint Committee.

26.74 Preservation of regulatory authority.

26.75 Suspension of recognition obligations.

26.76 Confidentiality.

26.77 Fees.

26.78 Agreements with other countries.

26.79 Territorial application.

26.80 Entry into force, amendment and termination.

26.81 Final provisions.

Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 343, 351,

352, 355, 360, 360b, 360c, 360d, 360e, 360f, 360g, 360h, 360i, 360j,

360l, 371, 374, 381, 382, 383, 393; 42 U.S.C. 216, 241, 242l, 262,

264, 265.

Sec. 26.0 General.

This part substantially reflects relevant provisions of the

proposed international agreement entitled, ``Agreement on Mutual

Recognition Between the United States of America and the European

Community'' (the MRA), including the ``umbrella'' text and its sectoral

annexes on pharmaceutical good manufacturing practices (GMP's) and

medical devices. Whereas the parties to the MRA would be the United

States and the European Community (EC), this part is relevant only to

the Food and Drug Administration's (FDA's) implementation of the MRA

and the

[[Page 17749]]

sectoral annexes cited in this section. For codification purposes,

certain provisions of the MRA have been modified for use in this part.

This modification is done for purposes of clarity only and shall not

affect the text of the MRA to be concluded between the United States

and the EC, or the rights and obligations of the United States or EC

under that agreement. References to the terms ``party'' or ``parties''

reflect FDA's proposed implementation of the MRA and its sectoral

annexes. It is understood that the EC will also be a party to the MRA

and that it will implement the MRA in accordance with its internal

procedures. If the parties to the MRA subsequently amend or terminate

the MRA, FDA will modify this part accordingly, using appropriate

administrative procedures.

Subpart A--Specific Sector Provisions for Pharmaceutical Good

Manufacturing Practices

Sec. 26.1 Definitions.

(a) Enforcement means action taken by an authority to protect the

public from products of suspect quality, safety, and efficacy or to

assure that products are manufactured in compliance with appropriate

laws, regulations, standards, and commitments made as part of the

approval to market a product.

(b) Equivalence of the regulatory systems means that the systems

are sufficiently comparable to assure that the process of inspection

and the ensuing inspection reports will provide adequate information to

determine whether respective statutory and regulatory requirements of

the authorities have been fulfilled. Equivalence does not require that

the respective regulatory systems have identical procedures.

definitions are to be merged by the parties at a future date.]

(1) GMP's mean the requirements found in the respective

legislations, regulations, and administrative provisions for methods to

be used in, and the facilities or controls to be used for, the

manufacturing, processing, packing, and/or holding of a drug to assure

that such drug meets the requirements as to safety, and has the

identity and strength, and meets the quality and purity characteristics

that it purports or is represented to possess.

(2) GMP's are that part of quality assurance which ensures that

products are consistently produced and controlled to quality standards.

For the purpose of this subpart, GMP's include, therefore, the system

whereby the manufacturer receives the specifications of the product

and/or process from the marketing authorization/product authorization

or license holder or applicant and ensures the product is made in

compliance with its specifications (qualified person certification in

the European Community (EC)).

(d) Inspection means an onsite evaluation of a manufacturing

facility to determine whether such manufacturing facility is operating

in compliance with GMP's and/or commitments made as part of the

approval to market a product.

(e) Inspection Report means the written observations and GMP's

compliance assessment completed by an authority listed in Appendix B of

this subpart.

(f) Regulatory System means the body of legal requirements for

GMP's, inspections, and enforcements that ensure public health

protection and legal authority to assure adherence to these

requirements.

Sec. 26.2 Purpose.

The provisions of this subpart govern the exchange between the

parties and normal endorsement by the receiving regulatory authority of

official good manufacturing practice (GMP) inspection reports after a

transitional period aimed at determination of the equivalence of the

regulatory systems of the parties, which is the cornerstone of this

subpart.

Sec. 26.3 Scope.

(a) The provisions of this subpart shall apply to pharmaceutical

inspections carried out in the United States and Member States of the

European Community (EC) before products are marketed (hereafter

referred to as ``preapproval inspections'') as well as during their

marketing (hereafter referred to as ``postapproval inspections'').

(b) Appendix A of this subpart names the laws, regulations, and

administrative provisions governing these inspections and the good

manufacturing practice (GMP) requirements.

in activities under this subpart.

(d) Sections 26.65, 26.66, 26.67, 26.68, 26.69, and 26.70 of

subpart C of this part do not apply to this subpart.

Sec. 26.4 Product coverage.

(a) These provisions will apply to medicinal products for human or

animal use, intermediates and starting materials (as referred to in the

European Community (EC)) and to drugs for human or animal use,

biological products for human use, and active pharmaceutical

ingredients (as referred to in the United States), only to the extent

they are regulated by the authorities of both parties as listed in

Appendix B of this subpart.

(b) Human blood, human plasma, human tissues and organs, and

veterinary immunologicals (under 9 CFR 101.2, ``veterinary

immunologicals'' are referred to as ``veterinary biologicals'') are

excluded from the scope of this subpart. Human plasma derivatives (such

as immunoglobulins and albumin), investigational medicinal products/new

drugs, human radiopharmaceuticals, and medicinal gases are also

excluded during the transition phase, their situation will be

reconsidered at the end of the transition period. Products regulated by

FDA's Center for Biologics Evaluation and Research as devices are not

covered under this subpart.

products covered by this subpart.

Sec. 26.5 Length of transition period.

A 3-year transition period will start immediately after the

effective date described in Sec. 26.80(a).

Sec. 26.6 Equivalence assessment.

(a) The criteria to be used by the parties to assess equivalence

are listed in Appendix D of this subpart. Information pertaining to the

criteria under European Community (EC) competence will be provided by

the EC.

(b) The authorities of the parties will establish and communicate

to each other their draft programs for assessing the equivalence of the

respective regulatory systems in terms of quality assurance of the

products and consumer protection. These programs will be carried out,

as deemed necessary by the regulatory authorities, for post- and

preapproval inspections and for various product classes or processes.

(including inspection reports), joint training, and joint inspections

for the purpose of assessing regulatory systems and the authorities'

capabilities. In conducting the equivalence assessment, the parties

will ensure that efforts are made to save resources.

(d) Equivalence assessment for authorities added to Appendix B of

this subpart after the effective date of this part as described in

Sec. 26.80(a) will be conducted as described in this subpart, as soon

as practicable.

[[Page 17750]]

Sec. 26.7 Participation in the equivalence assessment and

determination.

The authorities listed in Appendix B of this subpart will actively

participate in these programs to build a sufficient body of evidence

for their equivalence determination. Both parties will exercise good

faith efforts to complete equivalence assessment as expeditiously as

possible to the extent the resources of the authorities allow.

Sec. 26.8 Other transition activities.

As soon as possible, the authorities will jointly determine the

essential information which must be present in inspection reports and

will cooperate to develop mutually agreed inspection report format(s).

Sec. 26.9 Equivalence determination.

(a) Equivalence is established by having in place regulatory

systems covering the criteria referred to in Appendix D of this

subpart, and a demonstrated pattern of consistent performance in

accordance with these criteria. A list of authorities determined as

equivalent shall be agreed to by the Joint Sectoral Committee at the

end of the transition period, with reference to any limitation in terms

of inspection type (e.g., postapproval or preapproval) or product

classes or processes.

(b) The parties will document insufficient evidence of equivalence,

lack of opportunity to assess equivalence or a determination of

nonequivalence, in sufficient detail to allow the authority being

assessed to know how to attain equivalence.

Sec. 26.10 Regulatory authorities not listed as currently equivalent.

Authorities not currently listed as equivalent, or not equivalent

for certain types of inspections, product classes or processes may

apply for reconsideration of their status once the necessary corrective

measures have been taken or additional experience is gained.

Sec. 26.11 Start of operational period.

(a) The operational period shall start at the end of the transition

period and its provisions apply to inspection reports generated by

authorities listed as equivalent for the inspections performed in their

territory.

(b) In addition, when an authority is not listed as equivalent

based on adequate experience gained during the transition period, FDA

will accept for normal endorsement (as provided in Sec. 26.12)

inspection reports generated as a result of inspections conducted

jointly by that authority on its territory and another authority listed

as equivalent, provided that the authority of the Member State in which

the inspection is performed can guarantee enforcement of the findings

of the inspection report and require that corrective measures be taken

when necessary. FDA has the option to participate in these inspections,

and based on experience gained during the transition period, the

parties will agree on procedures for exercising this option.

relieved of responsibility for carrying the controls laid down in

Article 22 paragraph 1(b) of Council Directive 75/319/EEC (see Appendix

A of this subpart) provided that these controls have been carried out

in the United States and that each batch/lot is accompanied by a batch

certificate (in accordance with the World Health Organization

Certification Scheme on the Quality of Medicinal Products) issued by

the manufacturer certifying that the product complies with requirements

of the marketing authorization and signed by the person responsible for

releasing the batch/lot.

Sec. 26.12 Nature of recognition of inspection reports.

(a) Inspection reports (containing information as established under

Sec. 26.8), including a good manufacturing practice (GMP) compliance

assessment, prepared by authorities listed as equivalent, will be

provided to the authority of the importing party. Based on the

determination of equivalence in light of the experience gained, these

inspection reports will normally be endorsed by the authority of the

importing party, except under specific and delineated circumstances.

Examples of such circumstances include indications of material

inconsistencies or inadequacies in an inspection report, quality

defects identified in the postmarket surveillance or other specific

evidence of serious concern in relation to product quality or consumer

safety. In such cases, the authority of the importing party may request

clarification from the authority of the exporting party which may lead

to a request for reinspection. The authorities will endeavor to respond

to requests for clarification in a timely manner.

(b) Where divergence is not clarified in this process, an authority

of the importing country may carry out an inspection of the production

facility.

Sec. 26.13 Transmission of postapproval inspection reports.

Postapproval good manufacturing practice (GMP) inspection reports

concerning products covered by this subpart will be transmitted to the

authority of the importing country within 60 calendar days of the

request. Should a new inspection be needed, the inspection report will

be transmitted within 90 calendar days of the request.

Sec. 26.14 Transmission of preapproval inspection reports.

(a) A preliminary notification that an inspection may have to take

place will be made as soon as possible.

(b) Within 15 calendar days, the relevant authority will

acknowledge receipt of the request and confirm its ability to carry out

the inspection. In the European Community (EC), requests will be sent

directly to the relevant authority, with a copy to the European Agency

for the Evaluation of Medicinal Products (EMEA). If the authority

receiving the request cannot carry out the inspection as requested, the

requesting authority shall have the right to conduct the inspection.

calendar days of the request that transmitted the appropriate

information and detailed the precise issues to be addressed during the

inspection. A shorter time may be necessary in exceptional cases and

these will be described in the request.

Sec. 26.15 Monitoring continued equivalence.

Monitoring activities for the purpose of maintaining equivalence

shall include review of the exchange of inspection reports and their

quality and timeliness; performance of a limited number of joint

inspections; and the conduct of common training sessions.

Sec. 26.16 Suspension.

(a) Each party has the right to contest the equivalence of a

regulatory authority. This right will be exercised in an objective and

reasoned manner in writing to the other party.

(b) The issue shall be discussed in the Joint Sectoral Committee

promptly upon such notification. Where the Joint Sectoral Committee

determines that verification of equivalence is required, it may be

carried out jointly by the parties in a timely manner, under Sec. 26.6.

unanimous consent on the appropriate action. If agreement to suspend is

reached in the Joint Sectoral Committee, an authority may be suspended

immediately thereafter. If no agreement is reached in the Joint

Sectoral Committee, the matter is referred to the Joint Committee as

described in Sec. 26.73. If no unanimous consent is reached within 30

days after such notification, the contested authority will be

suspended.

(d) Upon the suspension of authority previously listed as

equivalent, a party

[[Page 17751]]

is no longer obligated to normally endorse the inspection reports of

the suspended authority. A party shall continue to normally endorse the

inspection reports of that authority prior to suspension, unless the

authority of the receiving party decides otherwise based on health or

safety considerations. The suspension will remain in effect until

unanimous consent has been reached by the parties on the future status

of that authority.

Sec. 26.17 Role and composition of the Joint Sectoral Committee.

(a) A Joint Sectoral Committee is set up to monitor the activities

under both the transitional and operational phases of this subpart.

(b) The Joint Sectoral Committee will be cochaired by a

representative of FDA for the United States and a representative of the

European Community (EC) who each will have one vote. Decisions will be

taken by unanimous consent.

(1) Making a joint assessment, which must be agreed by both

parties, of the equivalence of the respective authorities;

(2) Developing and maintaining the list of equivalent authorities,

including any limitation in terms of inspecting type or products, and

communicating the list to all authorities and the Joint Committee;

(3) Providing a forum to discuss issues relating to this subpart,

including concerns that an authority may be no longer equivalent and

opportunity to review product coverage; and

(4) Consideration of the issue of suspension.

(d) The Joint Sectoral Committee shall meet at the request of

either party and, unless the cochairs otherwise agree, at least once

each year. The Joint Committee will be kept informed of the agenda and

conclusions of meetings of the Joint Sectoral Committee.

Sec. 26.18 Regulatory collaboration.

(a) The parties and authorities shall inform and consult one

another, as permitted by law, on proposals to introduce new controls or

to change existing technical regulations or inspection procedures and

to provide the opportunity to comment on such proposals.

(b) The parties shall notify each other in writing of any changes

to Appendix B of this subpart.

Sec. 26.19 Information relating to quality aspects.

The authorities will establish an appropriate means of exchanging

information on any confirmed problem reports, corrective actions,

recalls, rejected import consignments and other regulatory and

enforcement problems for products subject to this subpart.

Sec. 26.20 Alert system.

(a) The details of an alert system will be developed during the

transitional period. The system will be maintained in place at all

times. Elements to be considered in developing such a system are

described in Appendix E of this subpart.

(b) Contact points will be agreed between both parties to permit

authorities to be made aware with the appropriate speed in case of

quality defect, recalls, counterfeiting, and other problems concerning

quality, which could necessitate additional controls or suspension of

the distribution of the product.

Sec. 26.21 Safeguard clause.

Each party recognizes that the importing country has a right to

fulfill its legal responsibilities by taking actions necessary to

ensure the protection of human and animal health at the level of

protection it deems appropriate. This includes the suspension of the

distribution, product detention at the border of the importing country,

withdrawal of the batches and any request for additional information or

inspection as provided in Sec. 26.12.

Appendix A of Subpart A--List of Applicable Laws, Regulations, and

Administrative Provisions

1. For the European Community:

[Copies of EC documents may be obtained from the European

Document Research, 1100 17th St. NW., suite 301, Washington, DC

20036. EC documents may be viewed on the European Commission

Pharmaceuticals Units web site at ``http://dg3.eudra.org.'']

Council Directive 65/65/EEC of 26 January 1965 on the approximation

of provisions laid down by law, regulation, or administrative action

relating to proprietary medicinal products as extended, widened, and

amended.

Council Directive 75/319/EEC of 20 May 1975 on the approximation of

provisions laid down by law, regulation or administrative action

relating to proprietary medicinal products as extended, widened and

amended.

Council Directive 81/851/EEC of 6 November 1981 on the approximation

of the laws of the Member States relating to veterinary medicinal

products as widened and amended.

Commission Directive 91/356/EEC of 13 June 1991 laying down the

principles and guidelines of good manufacturing practice for

medicinal products for human use.

Commission Directive 91/412/EEC of 23 July 1991 laying down the

principles and guidelines of good manufacturing practice for

veterinary medicinal products.

Council Regulation No (EEC) 2309/93 of 23 July 1993 laying down

Community procedures for the authorization and supervision of

medicinal products for human and veterinary use and establishing a

European Agency for the Evaluation of Medicinal Products.

Council Directive 92/25/EEC of 31 March 1992 on the wholesale

distribution of medicinal products for human use & Guide to Good

Distribution Practice.

Current version of the Guide to Good Manufacturing Practice, Rules

Governing Medicinal Products in the European Community, Volume IV.

2. For the United States :

[Copies of FDA documents may be obtained from the Government

Printing Office, 1510 H St. NW., Washington, DC 20005. FDA

documents, except the FDA Compliance Program Guidance Manual, may be

viewed on FDA's Internet web site at ``http://www.FDA.gov''.]

Relevant sections of the United States Federal Food, Drug, and

Cosmetic Act and the United States Public Health Service Act.

Relevant sections of Title 21, United States Code of Federal

Regulations (CFR) Parts 1-99, Parts 200-299, Parts 500-599, and

Parts 600-799.

Relevant sections of the FDA Investigations Operations Manual, the

FDA Regulatory Procedures Manual, the FDA Compliance Policy Guidance

Manual, the FDA Compliance Program Guidance Manual, and other FDA

guidances.

Appendix B of Subpart A--List of Authorities

1. For the United States:

In the United States, the regulatory authority is the Food and Drug

Administration.

2. For the European Community:

In the European Community, the regulatory authorities are the

following :

Austria: Bundesministerium Fur Arbeit, Gesundheit, und Soziales,

Wien.

Belgium: Ministerie van Sociale Zakem, Volksgezondheid en Leefmilieu

/Ministere des Affaires Sociales, Sante Publique et Environment/

Algemeine Farmaceutische Inspectie, Inspection Generale de la

Pharmacie, Bruxelles, Brussel.

Denmark: Laegemiddelstryelsen, (Danish Medicines Agency), Bronshoj.

Finland: Laakelaittos/Lakemedelsverket (National Agency for

Medicines), Helsinki.

France: Agence du Medicament, Direction de l'inspection et des

etablissements, Saint Denis. (Human). Agence Nationale du Medicament

Veterinaire, Fougeres (Veterinary).

Germany: Bundesgesundheitsministerium, Bonn. Paul-Ehrlich Institut,

Langen (biologicals only). Zustandige Behorden der 16 Bundeslander:

Bayern, Berlin Brandenberg, Bremen, Hamburg, Hessen, Niedersachsen,

Nordrhein-Westfalen, Rheinland-Pfalz, Mecklenberg-Vorpommern,

Saarland, Sachsen, Sachsenanhalt, Schleswog-Holstein, Thuringen.

Greece: Ministry of Health and Welfare, National Drug Organisation

(E.O.F.), Athens.

Ireland: Irish Medicines Board, Dublin.

[[Page 17752]]

Italy: Ministero della Sanita, Dipartimento Farmaci e

Farmacovigilanza, Roma. (Human). Ministero della Sanita,

Dipartimento alimenti e nutrizione e sanita pubblica veterinaria -

Div. IX, Roma (Veterinary).

Luxembourg: Direction de la Sante, Division de la Pharmacie et des

Medicaments, Luxembourg.

The Netherlands: Staatstoezicht op de Volksgezondheid, Inspectie

voor de Gezondheidszorg, Rijswijk.

Portugal: Instituto da Farmacia e do Medicamento (INFARMED), Lisboa.

Spain: Ministerio Sanidad y Consumo, Subdireccion. General de

Control Farmaceutico, Madrid. (Human) Ministerio de Agricultura

Pesca y Alimentacion, Madrid, (Veterinary).

Sweden: Lakemedelsverket (Medical Products Agency), Uppsala.

United Kingdom: Medicines Control Agency, London. Veterinary

Medicines Directorate, Addlestone.

European Union: European Commission, Brussels. European Agency for

the Evaluation of Medicinal Products (EMEA), London.

Appendix C of Subpart A--Indicative List of Products Covered by Subpart

Recognizing that precise definition of medicinal products and drugs

are to be found in the legislations referred to above, an indicative

list of products covered by this arrangement is given below:

- human medicinal products including prescription and

nonprescription drugs;

- human biologicals including vaccines, and immunologicals;

- veterinary pharmaceuticals, including prescription and

nonprescription drugs, with the exclusion of veterinary

immunologicals (Under 9 CFR 101.2 ``veterinary immunologicals'' are

referred to as ``veterinary biologicals.'');

- premixes for the preparation of veterinary medicated feeds

(EC), Type A medicated articles for the preparation of veterinary

medicated feeds (United States);

- intermediate products and active pharmaceutical ingredients or

bulk pharmaceuticals (United States)/starting materials (EC).

Appendix D of Subpart A--Criteria for Assessing Equivalence for Post-

and Preapproval

I. Legal/Regulatory authority and structures and procedures providing

for post- and preapproval:

A. Appropriate statutory mandate and jurisdiction.

B. Ability to issue and update binding requirements on GMP's and

guidance documents.

C. Authority to make inspections, review and copy documents, and to

take samples and collect other evidence.

D. Ability to enforce requirements and to remove products found in

violation of such requirements from the market.

E. Substantive current good manufacturing requirements.

F. Accountability of the regulatory authority.

G. Inventory of current products and manufacturers.

H. System for maintaining or accessing inspection reports, samples

and other analytical data, and other firm/product information

relating to matters covered by subpart A of this part.

II. Mechanisms in place to assure appropriate professional standards

and avoidance of conflicts of interest.

III. Administration of the regulatory authority:

A. Standards of education/qualification and training.

B. Effective quality assurance systems measures to ensure adequate

job performance.

C. Appropriate staffing and resources to enforce laws and

regulations.

IV. Conduct of inspections:

A. Adequate preinspection preparation, including appropriate

expertise of investigator/team, review of firm/product and

databases, and availability of appropriate inspection equipment.

B. Adequate conduct of inspection, including statutory access to

facilities, effective response to refusals, depth and competence of

evaluation of operations, systems, and documentation; collection of

evidence; appropriate duration of inspection and completeness of

written report of observations to firm management.

C. Adequate postinspection activities, including completeness of

inspectors' report, inspection report review where appropriate, and

conduct of followup inspections and other activities where

appropriate, assurance of preservation and retrieval of records.

V. Execution of regulatory enforcement actions to achieve corrections,

designed to prevent future violations, and to remove products found in

violation of requirements from the market.

VI. Effective use of surveillance systems:

A. Sampling and analysis.

B. Recall monitoring.

C. Product defect reporting system.

D. Routine surveillance inspections.

E. Verification of approved manufacturing process changes to

marketing authorizations/approved applications.

VII. Additional specific criteria for preapproval inspections:

A. Satisfactory demonstration through a jointly developed and

administered training program and joint inspections to assess the

regulatory authorities' capabilities.

B. Preinspection preparation includes the review of appropriate

records, including site plans and drug master file or similar

documentation to enable adequate inspections.

C. Ability to verify chemistry, manufacturing, and control data

supporting an application is authentic and complete.

D. Ability to assess and evaluate research and development data as

scientifically sound, especially transfer technology of pilot, scale

up and full scale production batches.

E. Ability to verify conformity of the onsite processes and

procedures with those described in the application.

F. Review and evaluate equipment installation, operational and

performance qualification data, and evaluate test method validation.

Appendix E of Subpart A--Elements to be Considered in Developing a Two-

way Alert System

1. Documentation

- Definition of a crisis/emergency and under what circumstances an

alert is required

- Standard Operating Procedures (SOP's)

- Mechanism of health hazards evaluation and classification

- Language of communication and transmission of information

2. Crisis Management System

- Crisis analysis and communication mechanisms

- Establishment of contact points

- Reporting mechanisms

3. Enforcement Procedures

- Followup mechanisms

- Corrective action procedures

4. Quality Assurance System

- Pharmacovigilance programme

- Surveillance/monitoring of implementation of corrective action

5. Contact Points

For the purpose of subpart A of this part, the contact points for

the alert system will be:

A. For the European Community:

the Executive Director of the European Agency for the Evaluation of

Medicinal Products, 7, Westferry Circus, Canary Wharf, UK - London

E14 4HB, England. Telephone 44-171-418 8400, Fax 418 8416.

B. For the United States :

Division of Emergency and Investigational Operations (DEIO), Food

and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

Telephone 301-443-1240, Fax 301-443-3757.

Subpart B--Specific Sector Provisions for Medical Devices

Sec. 26.31 Purpose.

(a) The purpose of this subpart is to specify the conditions under

which a party will accept the results of quality system-related

evaluations and inspections and premarket evaluations of the other

party with regard to medical devices as conducted by listed conformity

assessment bodies (CAB's) and to provide for other related cooperative

activities.

(b) This subpart is intended to evolve as programs and policies of

the parties evolve. The parties will review this subpart periodically,

in order to assess progress and identify potential enhancements to this

subpart as FDA and European Community (EC) policies evolve over time.

Sec. 26.32 Scope.

(a) The provisions of this subpart shall apply to the exchange and,

where appropriate, endorsement of the following types of reports from

conformity assessment bodies (CAB's) assessed to be equivalent:

[[Page 17753]]

(1) Under the U.S. system, surveillance/postmarket and initial/

preapproval inspection reports;

(2) Under the U.S. system, premarket (510(k)) product evaluation

reports;

(3) Under the European Community (EC) system, quality system

evaluation reports; and

(4) Under the EC system, EC type examination and verification

reports.

(b) Appendix A of this subpart names the legislation, regulations,

and related procedures under which:

(1) Products are regulated as medical devices by each party;

(2) CAB's are designated and confirmed; and

(3) These reports are prepared.

the EC are capable of conducting product and quality systems

evaluations against U.S. regulatory requirements in a manner equivalent

to those conducted by FDA; and CAB's in the United States are capable

of conducting product and quality systems evaluations against EC

regulatory requirements in a manner equivalent to those conducted by EC

CAB's.

Sec. 26.33 Product coverage.

(a) There are three components to this subpart each covering a

discrete range of products:

(1) Quality System Evaluations. U.S.-type surveillance/postmarket

and initial/preapproval inspection reports and European Community (EC)-

type quality system evaluation reports will be exchanged with regard to

all products regulated under both U.S. and EC law as medical devices.

(2) Product Evaluation. U.S.-type premarket (510(k)) product

evaluation reports and EC-type-testing reports will be exchanged only

with regard to those products classified under the U.S. system as Class

I/Class II-Tier 2 medical devices which are listed in Appendix B of

this subpart.

(3) Postmarket Vigilance Reports. Postmarket vigilance reports will

be exchanged with regard to all products regulated under both U.S. and

EC law as medical devices.

(b) Additional products and procedures may be made subject to this

subpart by agreement of the parties.

Sec. 26.34 Regulatory authorities.

The regulatory authorities shall have the responsibility of

implementing the provisions of this subpart, including the designation

and monitoring of conformity assessment bodies (CAB's). Regulatory

authorities will be specified in Appendix C of this subpart.. Each

party will promptly notify the other party in writing of any change in

the regulatory authority for a country.

Sec. 26.35 Length and purpose of transition period.

There will be a 3-year transition period immediately following the

date described in Sec. 26.80(a). During the transition period, the

parties will engage in confidence-building activities for the purpose

of obtaining sufficient evidence to make determinations concerning the

equivalence of conformity assessment bodies (CAB's) of the other party

with respect to the ability to perform quality system and product

evaluations or other reviews resulting in reports to be exchanged under

this subpart.

Sec. 26.36 Listing of CAB's.

Each party shall designate conformity assessment bodies (CAB's) to

participate in confidence-building activities by transmitting to the

other party a list of CAB's which meet the criteria for technical

competence and independence, as identified in Appendix A of this

subpart. The list shall be accompanied by supporting evidence.

Designated CAB's will be listed in Appendix D of this subpart for

participation in the confidence building activities once confirmed by

the importing party. Nonconfirmation would have to be justified based

on documented evidence.

Sec. 26.37 Confidence building activities.

(a) At the beginning of the transitional period, the Joint Sectoral

Group will establish a joint confidence building program calculated to

provide sufficient evidence of the capabilities of the designated

conformity assessment bodies (CAB's) to perform quality system or

product evaluations to the specifications of the parties.

(b) The joint confidence building program should include the

following actions and activities:

(1) Seminars designed to inform the parties and CAB's about each

party's regulatory system, procedures, and requirements;

(2) Workshops designed to provide the parties with information

regarding requirements and procedures for the designation and

surveillance of CAB's;

(3) Exchange of information about reports prepared during the

transition period;

(4) Joint training exercises; and

(5) Observed inspections.

identified with a CAB may be the subject of cooperative activities, as

resources allow and as agreed to by the regulatory authorities, aimed

at resolving the problem.

(d) Both parties will exercise good faith efforts to complete the

confidence building activities as expeditiously as possible to the

extent that the resources of the parties allow.

(e) Both the parties will each prepare annual progress reports

which will describe the confidence building activities undertaken

during each year of the transition period. The form and content of the

reports will be determined by the parties through the Joint Sectoral

Committee.

Sec. 26.38 Other transition period activities.

(a) During the transition period, the parties will jointly

determine the necessary information which must be present in quality

system and product evaluation reports.

(b) The parties will jointly develop a notification and alert

system to be used in case of defects, recalls, and other problems

concerning product quality that could necessitate additional actions

(e.g., inspections by the parties of the importing country) or

suspension of the distribution of the product.

Sec. 26.39 Equivalence assessment.

(a) In the final 6 months of the transition period, the parties

shall proceed to a joint assessment of the equivalence of the

conformity assessment bodies (CAB's) that participated in the

confidence building activities. CAB's will be determined to be

equivalent provided they have demonstrated proficiency through the

submission of a sufficient number of adequate reports. CAB's may be

determined to be equivalent with regard to the ability to perform any

type of quality system or product evaluation covered by this subpart

and with regard to any type of product covered by this subpart. The

parties shall develop a list contained in Appendix E of this subpart of

CAB's determined to be equivalent which shall contain a full

explanation of the scope of the equivalency determination, including

any appropriate limitations, with regard to performing any type of

quality system or product evaluation.

(b) The parties shall allow CAB's not listed for participation in

this subpart, or listed for participation only as to certain types of

evaluations, to apply for participation in this subpart once the

necessary measures have been taken or sufficient experience has been

gained, in accordance with Sec. 26.46.

by both parties.

[[Page 17754]]

Sec. 26.40 Start of the operational period.

(a) The operational period will start at the end of the transition

period after the parties have developed the list of conformity

assessment bodies (CAB's) found to be equivalent. The provisions of

Secs. 26.40, 26.41, 26.42, 26.43, 26.44, 26.45, and 26.46 will apply

only with regard to listed CAB's and only to the extent of any

specifications and limitations contained on the list with regard to a

CAB.

(b) The operational period will apply to quality system evaluation

reports and product evaluation reports generated by CAB's listed in

accordance with this subpart for the evaluations performed in the

respective territories of the parties, except if the parties agree

otherwise.

Sec. 26.41 Exchange and endorsement of quality system evaluation

reports.

(a) Listed European Community (EC) conformity assessment bodies

(CAB's) will provide FDA with reports of quality system evaluations, as

follows:

(1) For preapproval quality system evaluations, EC CAB's will

provide full reports; and

(2) For surveillance quality system evaluations, EC CAB's will

provide abbreviated reports.

(b) Listed U.S. CAB's will provide to the EC Notified Body of the

manufacturer's choice:

(1) Full reports of initial quality system evaluations;

(2) Abbreviated reports of quality systems surveillance audits.

information, the importing party may request additional clarification

from the CAB.

(d) Based on the determination of equivalence in light of the

experience gained, the quality system evaluation reports prepared by

the CAB's listed as equivalent will normally be endorsed by the

importing party, except under specific and delineated circumstances.

Examples of such circumstances include indications of material

inconsistencies or inadequacies in a report, quality defects identified

in postmarket surveillance or other specific evidence of serious

concern in relation to product quality or consumer safety. In such

cases, the importing party may request clarification from the exporting

party which may lead to a request for reinspection. The parties will

endeavor to respond to requests for clarification in a timely manner.

Where divergence is not clarified in this process, the importing party

may carry out the quality system evaluation.

Sec. 26.42 Exchange and endorsement of product evaluation reports.

(a) European Community (EC) conformity assessment bodies (CAB's)

listed for this purpose will, subject to the specifications and

limitations on the list, provide to FDA 510(k) premarket notification

assessment reports prepared to U.S. medical device requirements.

(b) U.S. CAB's will, subject to the specifications and limitations

on the list, provide to the EC Notified Body of the manufacturer's

choice, type examination, and verification reports prepared to EC

medical device requirements.

experience gained, the product evaluation reports prepared by the CAB's

listed as equivalent will normally be endorsed by the importing party,

except under specific and delineated circumstances. Examples of such

circumstances include indications of material inconsistencies,

inadequacies, or incompleteness in a product evaluation report, or

other specific evidence of serious concern in relation to product

safety, performance, or quality. In such cases, the importing party may

request clarification from the exporting party which may lead to a

request for a reevaluation. The parties will endeavor to respond to

requests for clarification in a timely manner. Endorsement remains the

responsibility of the importing party.

Sec. 26.43 Transmission of quality system evaluation reports.

Quality system evaluation reports covered by Sec. 26.41 concerning

products covered by this subpart shall be transmitted to the importing

party within 60 calendar days of a request by the importing party.

Should a new inspection be requested, the time period shall be extended

by an additional 30 calendar days. A party may request a new

inspection, for cause, identified to the other party. If the exporting

party cannot perform an inspection within a specified period of time,

the importing party may perform an inspection on its own.

Sec. 26.44 Transmission of product evaluation reports.

Transmission of product evaluation reports will take place

according to the importing party's specified procedures.

Sec. 26.45 Monitoring continued equivalence.

Monitoring activities will be carried out in accordance with

Sec. 26.69.

Sec. 26.46 Listing of additional CAB's.

(a) During the operational phase, additional conformity assessment

bodies (CAB's) will be considered for equivalence using the procedures

and criteria described in Secs. 26.36, 26.37, and 26.39, taking into

account the level of confidence gained in the overall regulatory system

of the other party.

(b) Once a designating authority considers that such CAB's, having

undergone the procedures of Secs. 26.36, 26.37, and 26.39, may be

determined to be equivalent, it will then designate those bodies on an

annual basis. Such procedures satisfy the procedures of Sec. 26.66(a)

and (b).

confirmation of CAB's under Sec. 26.66(c) and (d) shall apply.

Sec. 26.47 Role and composition of the Joint Sectoral Committee.

(a) The Joint Sectoral Committee for this subpart is set up to

monitor the activities under both the transitional and operational

phases of this subpart.

(b) The Joint Sectoral Committee will be cochaired by a

representative of the Food and Drug Administration (FDA) for the United

States and a representative of the European Community (EC) who will

each have one vote. Decisions will be taken by unanimous consent.

(1) Making a joint assessment of the equivalence of conformity

assessment bodies (CAB's);

(2) Developing and maintaining the list of equivalent CAB's,

including any limitation in terms of their scope of activities and

communicating the list to all authorities and the Joint Committee

described in subpart C of this part;

(3) Providing a forum to discuss issues relating to this subpart,

including concerns that a CAB may no longer be equivalent and

opportunity to review product coverage; and

(4) Consideration of the issue of suspension.

Sec. 26.48 Harmonization.

During both the transitional and operational phases of this

subpart, both parties intend to continue to participate in the

activities of the Global Harmonization Task Force and utilize the

results of those activities to the extent possible. Such participation

involves developing and reviewing documents developed by the Global

Harmonization Task Force and jointly determining whether they are

applicable to the implementation of this subpart.

Sec. 26.49 Regulatory cooperation.

(a) The parties and authorities shall inform and consult with one

another, as permitted by law, of proposals to

[[Page 17755]]

introduce new controls or to change existing technical regulations or

inspection procedures and to provide the opportunity to comment on such

proposals.

(b) The parties shall notify each other in writing of any changes

to Appendix A of this subpart.

Sec. 26.50 Alert system and exchange of postmarket vigilance reports.

(a) An alert system will be set up during the transition period and

maintained thereafter by which the parties will notify each other when

there is an immediate danger to public health. Elements of such a

system will be described in an Appendix F of this subpart. As part of

that system, each party shall notify the other party of any confirmed

problem reports, corrective actions, or recalls. These reports are

regarded as part of ongoing investigations.

(b) Contact points will be agreed between both parties to permit

authorities to be made aware with the appropriate speed in case of

quality defect, batch recalls, counterfeiting and other problems

concerning quality, which could necessitate additional controls or

suspension of the distribution of the product.

Appendix A of Subpart B--Relevant Legislation, Regulations and

Procedures

1. For the European Community (EC) the following legislation applies to

Sec. 26.42(a) of this subpart:

[Copies of EC documents may be obtained from the European

Document Research, 1100 17th St. NW., suite 301, Washington, DC

20036.]

a. Council Directive 90/385/EEC of 20 June 1990 on active

implantable medical devices

OJ No. L 189, 20.7. 1990, p. 17. Conformity assessment

procedures.

Annex 2 (with the exception of section 4)

Annex 4

Annex 5

b. Council Directive 93/42/EEC of 14 June 1993 on Medical Devices OJ

No. L 169,12.7.1993, p.1. Conformity assessment procedures.

Annex 2 (with the exception of section 4)

Annex 3

Annex 4

Annex 5

Annex 6

2. For the United States, the following legislation applies to

Sec. 26.32(a):

[Copies of FDA documents may be obtained from the Government

Printing Office, 1510 H St. NW., Washington, DC 20005. FDA documents

may be viewed on FDA's Internet web site at ``http://www.fda.gov''.]

a. The Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321 et seq.

b. The Public Health Service Act, 42 U.S.C. 201 et seq.

c. Regulations of the United States Food and Drug Administration

found at 21 CFR, in particular, Parts 800 to 1299.

d. Medical Devices; Third Party Review of Selected Premarket

Notifications; Pilot Program, 61 FR 14789-14796 (April 3, 1996).

Appendix B of Subpart B--Scope of Product Coverage

1. Initial Coverage of the Transition Period

Upon entry into force of this subpart as described in Sec. 26.80 (it

is understood that the date of entry into force will not occur prior

to June 1, 1998, unless the parties decide otherwise), products

qualifying for the transitional arrangements under this subpart

include:

a. All Class I products requiring premarket evaluations in the

United States--see Table 1.

b. Those Class II products listed in Table 2.

2. During the Transition Period

The parties will jointly identify additional product groups,

including their related accessories, in line with their respective

priorities as follows:

a. Those for which review may be based primarily on written

guidance which the parties will use their best efforts to prepare

expeditiously; and

b. Those for which review may be based primarily on

international standards, in order for the parties to gain the

requisite experience.

The corresponding additional product lists will be phased in on an

annual basis. The parties may consult with industry and other

interested parties in determining which products will be added.

3. Commencement of the Operational Period

a. At the commencement of the operational period, product

coverage shall extend to all Class I/II products covered during the

transition period.

b. FDA will expand the program to categories of Class II devices

as is consistent with the results of the pilot, and with FDA's

ability to write guidance documents if the device pilot for the

third party review of medical devices is successful. The MRA will

cover to the maximum extent feasible all Class II devices listed in

Table 3 for which FDA-accredited third party review is available in

the United States.

4. Unless explicitly included by joint decision of the parties, this

part does not cover any U.S. Class II-tier 3 or any Class III product

under either system.

[FDA is codifying the lists of medical devices contained in the

following tables as they appear in the medical device annex of the

``Agreement on Mutual Recognition Between the United States of

America and the European Community.'' As a result of the Food and

Drug Administration Modernization Act of 1997, however, the medical

devices included in these tables will change.]

Table 1.--Class I Products Requiring Premarket Evaluations in the United

States, Included in Scope of Product Coverage at Beginning of Transition

Period\1\

------------------------------------------------------------------------

21 CFR Section No. Regulation Name

------------------------------------------------------------------------

Product Code--Device Name

------------------------------------------------------------------------

Anesthesiology Panel (21 CFR Part

868)

868.1910 Esophageal Stethoscope

BZW--Stethoscope, Esophageal

868.5620 Breathing Mouthpiece

BYP--Mouthpiece, Breathing

868.5640 Medicinal Nonventilatory

Nebulizer (Atomizer)

CCQ--Nebulizer, Medicinal,

Nonventilatory (Atomizer)

868.5675 Rebreathing Device

BYW--Device, Rebreathing

868.5700 Nonpowered Oxygen Tent

FOG--Hood, Oxygen, Infant

BYL--Tent, Oxygen

868.6810 Tracheobronchial Suction Catheter

BSY--Catheters, Suction,

Tracheobronchial

[[Page 17756]]

Cardiovascular Panel

(None)

Dental Panel (21 CFR Part 872)

872.3400 Karaya and Sodium Borate With or

Without Acacia Denture Adhesive

KOM--Adhesive, Denture, Acacia

and Karaya With Sodium Borate

872.3700 Dental Mercury (U.S.P.)

ELY--Mercury

872.4200 Dental Handpiece and Accessories

EBW--Controller, Food, Handpiece

and Cord

EFB--Handpiece, Air-Powered,

Dental

EFA--Handpiece, Belt and/or Gear

Driven, Dental

EGS--Handpiece, Contra- and Right-

Angle Attachment, Dental

EKX--Handpiece, Direct Drive, AC-

Powered

EKY--Handpiece, Water-Powered

872.6640 Dental Operative Unit and

Accessories

EIA--Unit, Operative Dental

Ear, Nose, and Throat Panel (21 CFR

Part 874)

874.1070 Short Increment Sensitivity Index

(SISI) Adapter

ETR--Adapter, Short Increment

Sensitivity Index (SISI)

874.1500 Gustometer

ETM--Gustometer

874.1800 Air or Water Caloric Stimulator

KHH--Stimulator, Caloric-Air

ETP--Stimulator, Caloric-Water

874.1925 Toynbee Diagnostic Tube

ETK--Tube, Toynbee Diagnostic

874.3300 Hearing Aid

LRB--Face Plate Hearing-Aid

ESD--Hearing-aid, Air-Conduction

874.4100 Epistaxis Balloon

EMX--Balloon, Epistaxis

874.5300 ENT Examination and Treatment

Unit

ETF--Unit, Examining/Treatment,

ENT

874.5550 Powered Nasal Irrigator

KMA--Irrigator, Powered Nasal

874.5840 Antistammering Device

KTH--Device, Anti-Stammering

Gastroenterology--Urology Panel (21

CFR Part 876)

876.5160 Urological Clamp for Males

FHA--Clamp, Penile

876.5210 Enema Kit

FCE--Kit, Enema, (for Cleaning

Purpose)

876.5250 Urine Collector and Accessories

FAQ--Bag, Urine Collection, Leg,

for External Use

General Hospital Panel (21 CFR Part

880)

880.5270 Neonatal Eye Pad

FOK--Pad, Neonatal Eye

880.5420 Pressure Infusor for an I.V. Bag

KZD--Infusor, Pressure, for I.V.

Bags

880.5680 Pediatric Position Holder

FRP--Holder, Infant Position

880.6250 Patient Examination Glove

LZB--Finger Cot

FMC--Glove, Patient Examination

LYY--Glove, Patient Examination,

Latex

LZA--Glove, Patient Examination,

Poly

LZC--Glove, Patient Examination,

Speciality

LYZ--Glove, Patient Examination,

Vinyl

880.6375 Patient Lubricant

KMJ--Lubricant, Patient

880.6760 Protective Restraint

BRT--Restraint, Patient,

Conductive

FMQ--Restraint, Protective

Neurology Panel (21 CFR Part 882)

882.1030 Ataxiagraph

GWW--Ataxiagraph

882.1420 Electroencephalogram (EEG) Signal

Spectrum Analyzer

GWS--Analyzer, Spectrum,

Electroencephalogram Signal

[[Page 17757]]

882.4060 Ventricular Cannula

HCD--Cannula, Ventricular

882.4545 Shunt System Implantation

Instrument

GYK--Instrument, Shunt System

Implantation

882.4650 Neurosurgical Suture Needle

HAS--Needle, Neurosurgical Suture

882.4750 Skull Punch

GXJ--Punch, Skull

Obstetrics and Gynecology Panel

(None)

Ophthalmology Panel (21 CFR Part 886)

886.1780 Retinoscope

HKM--Retinoscope, Battery-Powered

886.1940 Tonometer Sterilizer

HKZ--Sterilizer, Tonometer

886.4070 Powered Corneal Burr

HQS--Burr, Corneal, AC-Powered

HOG--Burr, Corneal, Battery-

Powered

HRG--Engine, Trephine,

Accessories, AC-Powered

HFR--Engine, Trephine,

Accessories, Battery-Powered

HLD--Engine, Trephine,

Accessories, Gas-Powered

886.4370 Keratome

HNO--Keratome, AC-Powered

HMY--Keratome, Battery-Powered

886.5850 Sunglasses (Nonprescription)

HQY--Sunglasses (Nonprescription

Including Photosensitive)

Orthopedic Panel (21 CFR Part 888)

888.1500 Goniometer

KQX--Goniometer, AC-Powered

888.4150 Calipers for Clinical Use

KTZ--Caliper

Physical Medicine Panel (21 CFR Part

890)

890.3850 Mechanical Wheelchair

LBE--Stroller, Adaptive

IOR--Wheelchair, Mechanical

890.5180 Manual Patient Rotation Bed

INY--Bed, Patient Rotation,

Manual

890.5710 Hot or Cold Disposable Pack

IMD--Pack, Hot or Cold,

Disposable

Radiology Panel (21 CFR Part 892)

892.1100 Scintillation (Gamma) Camera

IYX--Camera, Scintillation

(Gamma)

892.1110 Positron Camera

IZC--Camera, Positron

892.1300 Nuclear Rectilinear Scanner

IYW--Scanner, Rectilinear,

Nuclear

892.1320 Nuclear Uptake Probe

IZD--Probe, Uptake, Nuclear

892.1330 Nuclear Whole Body Scanner

JAM--Scanner, Whole Body, Nuclear

892.1410 Nuclear Electrocardiograph

Synchronizer

IVY--Synchronizer,

Electrocardiograph, Nuclear

892.1890 Radiographic Film Illuminator

IXC--Illuminator, Radiographic-

Film

JAG--Illuminator, Radiographic-

Film, Explosion-Proof

892.1910 Radiographic Grid

IXJ--Grid, Radiographic

892.1960 Radiographic Intensifying Screen

WAM--Screen, Intensifying,

Radiographic

892.1970 Radiographic ECG/Respirator

Synchronizer

IXO--Synchronizer, ECG/

Respirator, Radiographic

892.5650 Manual Radionuclide Applicator

System

IWG--System, Applicator,

Radionuclide, Manual

General and Plastic Surgery Panel (21

CFR Part 878)

878.4200 Introduction/Drainage Catheter

and Accessories

KGZ--Accessories, Catheter

GCE--Adaptor, Catheter

FGY--Cannula, Injection

GBA--Catheter, Balloon Type

[[Page 17758]]

GBZ--Catheter, Cholangiography

GBQ--Catheter, Continuous

Irrigation

GBY--Catheter, Eustachian,

General & Plastic Surgery

JCY--Catheter, Infusion

GBX--Catheter, Irrigation

GBP--Catheter, Multiple Lumen

GBO--Catheter, Nephrostomy,

General & Plastic Surgery

GBN--Catheter, Pediatric, General

& Plastic Surgery

GBW--Catheter, Peritoneal

GBS--Catheter, Ventricular,

General & Plastic Surgery

GCD--Connector, Catheter

GCC--Dilator, Catheter

GCB--Needle, Catheter

878.4320 Removable Skin Clip

FZQ--Clip, Removable (Skin)

878.4460 Surgeon's Gloves

KGO--Surgeon's Gloves

878.4680 Nonpowered, Single Patient,

Portable Suction Apparatus

GCY--Apparatus, Suction, Single

Patient Use, Portable,

Nonpowered

878.4760 Removable Skin Staple

GDT--Staple, Removable (Skin)

878.4820 AC-Powered, Battery-Powered, and

Pneumatically Powered Surgical

Instrument Motors and

Accessories/Attachments

GFG--Bit, Surgical

GFA--Blade, Saw, General &

Plastic Surgery

DWH--Blade, Saw, Surgical,

Cardiovascular

BRZ--Board, Arm (With Cover)

GFE--Brush, Dermabrasion

GFF--Bur, Surgical, General &

Plastic Surgery

KDG--Chisel (Osteotome)

GFD--Dermatome

GFC--Driver, Surgical, Pin

GFB--Head, Surgical, Hammer

GEY--Motor, Surgical Instrument,

AC-Powered

GET--Motor, Surgical Instrument,

Pneumatic Powered

DWI--Saw, Electrically Powered

KFK--Saw, Pneumatically Powered

HAB--Saw, Powered, and

Accessories

878.4960 Air or AC-Powered Operating Table

and Air or AC-Powered Operating

Chair & Accessories

GBB--Chair, Surgical, AC-Powered

FQO--Table, Operating-Room, AC-

Powered

GDC--Table, Operating-Room,

Electrical

FWW--Table, Operating-Room,

Pneumatic

JEA--Table, Surgical with

Orthopedic Accessories, AC-

Powered

880.5090 Liquid Bandage

KMF--Bandage, Liquid

------------------------------------------------------------------------

\1\Descriptive information on product codes, panel codes, and other

medical device identifiers may be viewed on FDA's Internet Web Site at

``http://www.fda.gov/cdrh/prodcode.html''.

Table 2.--Class II Medical Devices Included in Scope of Product Coverage

at Beginning of Transition Period (United States to develop guidance

documents identifying U.S. requirements and European Community (EC) to

identify standards needed to meet EC requirements)\1\

------------------------------------------------------------------------

Panel 21 CFR Section Regulation Name

---------------- No. --------------------------------------

------------------

Product Code--Device Name

------------------------------------------------------------------------

RA 892.1000 Magnetic Resonance Diagnostic Device

MOS--COIL, Magnetic Resonance,

Specialty

LNH--System, Nuclear Magnetic

Resonance Imaging

LNI--System, Nuclear Magnetic

Resonance Spectroscopic

Diagnostic

Ultrasound:

RA 892.1540 Nonfetal Ultrasonic Monitor

JAF--Monitor, Ultrasonic, Nonfetal

RA 892.1550 Ultrasonic Pulsed Doppler Imaging

System

IYN--System, Imaging, Pulsed Doppler,

Ultrasonic

[[Page 17759]]

RA 892.1560 Ultrasonic Pulsed Echo Imaging System

................ IYO--System, Imaging, Pulsed Echo,

Ultrasonic

RA 892.1570 Diagnostic Ultrasonic Transducer

................ ITX--Transducer, Ultrasonic,

Diagnostic

Diagnostic X-

Ray Imaging

Devices

(except

mammographic x-

ray systems):

RA 892.1600 Angiographic X-Ray System

IZI--System, X-Ray, Angiographic

RA 892.1650 Image-Intensified Fluoroscopic X-Ray

System

MQB--Solid State X-Ray Imager (Flat

Panel/Digital Imager)

JAA--System, X-Ray, Fluoroscopic,

Image-Intensified

RA 892.1680 Stationary X-Ray System

KPR--System, X-Ray, Stationary

RA 892.1720 Mobile X-Ray System

IZL--System, X-Ray, Mobile

RA 892.1740 Tomographic X-Ray System

IZF--System, X-Ray, Tomographic

RA 892.1750 Computed Tomography X-Ray System

JAK--System, X-Ray, Tomography,

Computed

ECG-Related

Devices:

CV 870.2340 Electrocardiograph

................ DPS--Electrocardiograph

................ MLC--Monitor, ST Segment

CV 870.2350 Electrocardiograph Lead Switching

Adaptor

DRW--Adaptor, Lead Switching,

Electrocardiograph

CV 870.2360 Electrocardiograph Electrode

DRX--Electrode, Electrocardiograph

CV 870.2370 Electrocardiograph Surface Electrode

Tester

KRC--Tester, Electrode, Surface,

Electrocardiographic

NE 882.1400 Electroencephalograph

GWQ--Electroencephalograph

HO 880.5725 Infusion Pump (external only)

MRZ--Accessories, Pump, Infusion

FRN--Pump, Infusion

LZF--Pump, Infusion, Analytical

Sampling

MEB--Pump, Infusion, Elastomeric

LZH--Pump, Infusion, Enteral

MHD--Pump, Infusion, Gallstone

Dissolution

LZG--Pump, Infusion, Insulin

MEA--Pump, Infusion, PCA

Ophthalmic

Instruments:

OP 886.1570 Ophthalmoscope

HLI--Ophthalmoscope, AC-Powered

HLJ--Ophthalmoscope, Battery-Powered

OP 886.1780 Retinoscope

HKL--Retinoscope, AC-Powered

OP 886.1850 AC-Powered Slit-Lamp Biomicroscope

HJO--Biomicroscope, Slit-Lamp, AC-

Powered

OP 886.4150 Vitreous Aspiration and Cutting

Instrument

MMC--Dilator, Expansive Iris

(Accessory)

HQE--Instrument, Vitreous Aspiration

and Cutting, AC-Powered

HKP--Instrument, Vitreous Aspiration

and Cutting, Battery-Powered

MLZ--Vitrectomy, Instrument Cutter

OP 886.4670 Phacofragmentation System

HQC--Unit, Phacofragmentation

SU 878.4580 Surgical Lamp

HBI--Illuminator, Fiberoptic,

Surgical Field

FTF--Illuminator, Nonremote

FTG--Illuminator, Remote

HJE--Lamp, Fluorescein, AC-Powered

FQP--Lamp, Operating-Room

FTD--Lamp, Surgical

GBC--Lamp, Surgical, Incandescent

FTA--Light, Surgical, Accessories

FSZ--Light, Surgical, Carrier

FSY--Light, Surgical, Ceiling Mounted

[[Page 17760]]

FSX--Light, Surgical, Connector

FSW--Light, Surgical, Endoscopic

FST--Light, Surgical, Fiberoptic

FSS--Light, Surgical, Floor Standing

FSQ--Light, Surgical, Instrument

NE 882.5890 Transcutaneous Electrical Nerve

Stimulator for Pain Relief

GZJ--Stimulator, Nerve,

Transcutaneous, For Pain Relief

Noninvasive Blood Pressure

Measurement Devices:

CV 870.1120 Blood Pressure Cuff

DXQ--Cuff, Blood-Pressure

CV 870.1130 Noninvasive Blood Pressure

Measurement System (except

nonoscillometric)

DXN--System, Measurement, Blood-

Pressure, Noninvasive

HO 880.6880 Steam Sterilizer (greater than 2

cubic feet)

FLE--Sterilizer, Steam

Clinical

Thermometers:

HO 880.2910 Clinical Electronic Thermometer

(except tympanic or pacifier)

FLL--Thermometer, Electronic,

Clinical

AN 868.5630 Nebulizer

CAF--Nebulizer (Direct Patient

Interface)

AN 868.5925 Powered Emergency Ventilator

Hypodermic

Needles and

Syringes

(except

antistick and

self-

destruct):

HO 880.5570 Hypodermic Single Lumen Needle

MMK--Container, Sharpes

FMI--Needle, Hypodermic, Single Lumen

MHC--Port, Intraosseous, Implanted

HO 880.5860 Piston Syringe

FMF--Syringe, Piston

OR 888.3020 Intramedullary Fixation Rod

HSB--ROD, Fixation, Intramedullary

and Accessories

External

Fixators

(except

devices with

no external

components):

OR 888.3030 Single/Multiple Component Metallic

Bone Fixation Appliances and

Accessories

KTT--Appliance, Fixation, Nail/Blade/

Plate Combination, Multiple

Component

OR 888.3040 Smooth or Threaded Metallic Bone

Fixation Fastener

JEC--Component, Traction, Invasive

HTY--Pin, Fixation, Smooth

JDW--Pin, Fixation, Threaded

Selected Dental

Materials:

DE 872.3060 Gold-Based Alloys and Precious Metal

Alloys for Clinical Use

EJT--Alloy, Gold Based, For Clinical

Use

EJS--Alloy, Precious Metal, For

Clinical Use

DE 872.3200 Resin Tooth Bonding Agent

KLE--Agent, Tooth Bonding, Resin

DE 872.3275 Dental Cement

EMA--Cement, Dental

EMB--Zinc Oxide Eugenol

DE 872.3660 Impression Material

ELW--Material, Impression

DE 872.3690 Tooth Shade Resin Material

EBF--Material, Tooth Shade, Resin

DE 872.3710 Base Metal Alloy

EJH--Metal, Base

Latex Condoms:

OB 884.5300 Condom

HIS--Condom

------------------------------------------------------------------------

\1\Descriptive information on product codes, panel codes, and other

medical device identifiers may be viewed on FDA's Internet Web Site at

``http://www.fda.gov/cdrh/prodcode.html''.

[[Page 17761]]

Table 3.--Medical Devices for Possible Inclusion in Scope of Product

Coverage During Operational Period\1\

------------------------------------------------------------------------

Product Family 21 CFR Section No Device Name Tier

------------------------------------------------------------------------

Anesthesiology

Panel

Anesthesia 868.5160 Gas machine for 2

Devices anesthesia or

analgesia

868.5270 Breathing system 2

heater

868.5440 Portable oxygen 2

generator

868.5450 Respiratory gas 2

humidifier

868.5630 Nebulizer 2

868.5710 Electrically 2

powered oxygen

tent

868.5880 Anesthetic 2

vaporizer

Gas Analyser 868.1040 Powered 2

Algesimeter

868.1075 Argon gas 2

analyzer

868.1400 Carbon dioxide 2

gas analyzer

868.1430 Carbon monoxide 2

gas analyzer

868.1500 Enflurane gas 2

analyzer

868.1620 Halothane gas 2

analyzer

868.1640 Helium gas 2

analyzer

868.1670 Neon gas 2

analyzer

868.1690 Nitrogen gas 2

analyzer

868.1700 Nitrous oxide 2

gas analyzer

868.1720 Oxygen gas 2

analyzer

868.1730 Oxygen uptake 2

computer

Peripheral 868.2775 Electrical 2

Nerve peripheral

Stimulators nerve

stimulator

Respiratory 868.1750 Pressure 2

Monitoring plethysmograph

868.1760 Volume 2

plethysmograph

868.1780 Inspiratory 2

airway pressure

meter

868.1800 Rhinoanemometer 2

868.1840 Diagnostic 2

spirometer

868.1850 Monitoring 2

spirometer

868.1860 Peak-flow meter 2

for spirometry

868.1880 Pulmonary- 2

function data

calculator

868.1890 Predictive 2

pulmonary-

function value

calculator

868.1900 Diagnostic 2

pulmonary-

function

interpretation

calculator

868.2025 Ultrasonic air 2

embolism

monitor

868.2375 Breathing 2

frequency

monitor (except

apnea

detectors)

868.2480 Cutaneous carbon 2

dioxide (PcCO2)

monitor

868.2500 Cutaneous oxygen 2

monitor (for an

infant not

under gas

anesthesia)

868.2550 Pneumotachomomet 2

868.2600 Airway pressure 2

monitor

868.5665 Powered 2

percussor

868.5690 Incentive 2

spirometer

Ventilator 868.5905 Noncontinuous 2

ventilator

(IPPB)

868.5925 Powered 2

emergency

ventilator

868.5935 External 2

negative

pressure

ventilator

868.5895 Continuous 2

ventilator

868.5955 Intermittent 2

mandatory

ventilation

attachment

868.6250 Portable air 2

compressor

Cardiovascular

Panel

Cardiovascula 870.1425 Programmable 2

r Diagnostic diagnostic

computer

870.1450 Densitometer 2

870.2310 Apex cardiograph 2

(vibrocardiogra

ph)

870.2320 Ballistocardiogr 2

aph

870.2340 Electrocardiogra 2

870.2350 Electrocardiogra 1

ph lead

switching

adaptor

870.2360 Electrocardiogra 2

ph electrode

870.2370 Electrocardiogra 2

ph surface

electrode

tester

870.2400 Vectorcardiograp 1

870.2450 Medical cathode- 1

ray tube

display

[[Page 17762]]

870.2675 Oscillometer 2

870.2840 Apex 2

cardiographic

transducer

870.2860 Heart sound 2

transducer

Cardiovascula Valve, pressure

r Monitoring relief,

cardiopulmonary

bypass

870.1100 Blood pressure 2

alarm

870.1110 Blood pressure 2

computer

870.1120 Blood pressure 2

cuff

870.1130 Noninvasive 2

blood pressure

measurement

system

870.1140 Venous blood 2

pressure

manometer

870.1220 Electrode 2

recording

catheter or

electrode

recording probe

870.1270 Intracavitary 2

phonocatheter

system

870.1875 Stethoscope 2

(electronic)

870.2050 Biopotential 2

amplifier and

signal

conditioner

870.2060 Transducer 2

signal

amplifier and

conditioner

870.2100 Cardiovascular 2

blood flow-

meter

870.2120 Extravascular 2

blood flow

probe

870.2300 Cardiac monitor 2

(including

cardiotachomete

r and rate

alarm)

870.2700 Oximeter 2

870.2710 Ear oximeter 2

870.2750 Impedance 2

phlebograph

870.2770 Impedance 2

plethysmograph

870.2780 Hydraulic, 2

pneumatic, or

photoelectric

plethysmographs

870.2850 Extravascular 2

blood pressure

transducer

870.2870 Catheter tip 2

pressure

transducer

870.2880 Ultrasonic 2

transducer

870.2890 Vessel occlusion 2

transducer

870.2900 Patient 2

transducer and

electrode cable

(including

connector)

870.2910 Radiofrequency 2

physiological

signal

transmitter and

receiver

870.2920 Telephone 2

electrocardiogr

aph transmitter

and receiver

870.4205 Cardiopulmonary 2

bypass bubble

detector

870.4220 Cardiopulmonary 2

bypass heart-

lung machine

console

870.4240 Cardiovascular 2

bypass heat

exchanger

870.4250 Cardiopulmonary 2

bypass

temperature

controller

870.4300 Cardiopulmonary 2

bypass gas

control unit

870.4310 Cardiopulmonary 2

bypass coronary

pressure gauge

870.4330 Cardiopulmonary 2

bypass on-line

blood gas

monitor

870.4340 Cardiopulmonary 2

bypass level

sensing monitor

and/or control

870.4370 Roller-type 2

cardiopulmonary

bypass blood

pump

870.4380 Cardiopulmonary 2

bypass pump

speed control

870.4410 Cardiopulmonary 2

bypass in-line

blood gas

sensor

Cardiovascula 870.5050 Patient care 2

r suction

Therapeutic apparatus

870.5900 Thermal 2

regulation

system

Defibrillator 870.5300 DC- 2

defribrillator

(including

paddles)

870.5325 Defibrillator 2

tester

[[Page 17763]]

Echocardiogra 870.2330 Echocardiograph 2

Pacemaker & 870.1750 External 2

Accessories programmable

pacemaker pulse

generator

870.3630 Pacemaker 2

generator

function

analyzer

870.3640 Indirect 2

pacemaker

generator

function

analyzer

870.3720 Pacemaker 2

electrode

function tester

Miscellaneous 870.1800 Withdrawal- 2

infusion pump

870.2800 Medical magnetic 2

tape recorder

None Batteries,

rechargeable,

class II

devices

Dental Panel

Dental 872.1720 Pulp tester 2

Equipment

872.1740 Caries detection 2

device

872.4120 Bone cutting 2

instrument and

accessories

872.4465 Gas-powered jet 2

injector

872.4475 Spring-powered 2

jet injector

872.4600 Intraoral 2

ligature and

wire lock

872.4840 Rotary scaler 2

872.4850 Ultrasonic 2

scaler

872.4920 Dental 2

electrosurgical

unit and

accessories

872.6070 Ultraviolet 2

activator for

polymerization

872.6350 Ultraviolet 2

detector

Dental 872.3050 Amalgam alloy 2

Material

872.3060 Gold-based 2

alloys and

precious metal

alloys for

clinical use

872.3200 Resin tooth 2

bonding agent

872.3250 Calcium 2

hydroxide

cavity liner

872.3260 Cavity varnish 2

872.3275 Dental cement 2

(other than

zinc oxide-

eugenol)

872.3300 Hydrophilic 2

resin coating

for dentures

872.3310 Coating material 2

for resin

fillings

872.3590 Preformed 2

plastic denture

tooth

872.3660 Impression 2

material

872.3690 Tooth shade 2

resin material

872.3710 Base metal alloy 2

872.3750 Bracket adhesive 2

resin and tooth

conditioner

872.3760 Denture 2

relining,

repairing, or

rebasing resin

872.3765 Pit and fissure 2

sealant and

conditioner

872.3770 Temporary crown 2

and bridge

resin

872.3820 Root canal 2

filling resin

(other than

chloroform use)

872.3920 Porcelain tooth 2

Dental X-ray 872.1800 Extraoral source 2

x-ray system

872.1810 Intraoral source 2

x-ray system

Dental 872.4880 Intraosseous 2

Implants fixation screw

or wire

872.3890 Endodontic 2

stabilizing

splint

Orthodontic 872.5470 Orthodontic 2

plastic bracket

Ear/Nose/Throat

Panel

Diagnostic 874.1050 Audiometer 2

Equipment

874.1090 Auditory 2

impedance

tester

874.1120 Electronic noise 2

generator for

audiometric

testing

874.1325 Electroglottogra 2

874.1820 Surgical nerve 2

stimulator/

locator

Hearing Aids 874.3300 Hearing aid (for 2

bone-

conduction)

874.3310 Hearing aid 2

calibrator and

analysis system

874.3320 Group hearing 2

aid or group

auditory

trainer

[[Page 17764]]

874.3330 Master hearing 2

aid

Surgical 874.4250 Ear, nose, and 1

Equipment throat electric

or pneumatic

surgical drill

874.4490 Argon laser for 2

otology,

rhinology, and

laryngology

874.4500 Ear, nose, and 2

throat

microsurgical

carbon dioxide

laser

Gastroenterology/

Urology Panel

Endoscope 876.1500 Endoscope and 2

(including accessories

angioscopes,

laparscopes,

ophthalmic

endoscopes)

876.4300 Endoscopic 2

electrosurgical

unit and

accessories

Gastroenterol 876.1725 Gastrointestinal 1

ogy motility

monitoring

system

Hemodialysis 876.5600 Sorbent 2

regenerated

dialysate

delivery system

for

hemodialysis

876.5630 Peritoneal 2

dialysis system

and accessories

876.5665 Water 2

purification

system for

hemodialysis

876.5820 Hemodialysis 2

system and

accessories

876.5830 Hemodialyzer 2

with disposable

insert (kiil-

type)

Lithotriptor 876.4500 Mechanical 2

lithotriptor

Urology 876.1620 Urodynamics 2

Equipment measurement

system

876.5320 Nonimplanted 2

electrical

continence

device

876.5880 Isolated kidney 2

perfusion and

transport

system and

accessories

General Hospital

Panel

Infusion 880.2420 Electronic 2

Pumps and monitor for

Systems gravity flow

infusion

systems

880.2460 Electrically 2

powered spinal

fluid pressure

monitor

880.5430 Nonelectrically 2

powered fluid

injector

880.5725 Infusion pump 2

Neonatal 880.5400 Neonatal 2

Incubators incubator

880.5410 Neonatal 2

transport

incubator

880.5700 Neonatal 2

phototherapy

unit

Piston 880.5570 Hypodermic 1

Syringes single lumen

needle

880.5860 Piston syringe 1

(except

antistick)

880.6920 Syringe needle 2

introducer

Miscellaneous 880.2910 Clinical 2

electronic

thermometer

880.2920 Clinical mercury 2

thermometer

880.5100 AC-powered 1

adjustable

hospital bed

880.5500 AC-powered 2

patient lift

880.6880 Steam sterilizer 2

(greater than 2

cubic feet)

Neurology Panel

882.1020 Rigidity 2

analyzer

882.1610 Alpha monitor 2

Neuro- 882.1320 Cutaneous 2

Diagnostic electrode

882.1340 Nasopharyngeal 2

electrode

882.1350 Needle electrode 2

882.1400 Electroencephalo 2

graph

882.1460 Nystagmograph 2

882.1480 Neurological 2

endoscope

882.1540 Galvanic skin 2

response

measurement

device

882.1550 Nerve conduction 2

velocity

measurement

device

882.1560 Skin potential 2

measurement

device

882.1570 Powered direct- 2

contact

temperature

measurement

device

[[Page 17765]]

882.1620 Intracranial 2

pressure

monitoring

device

882.1835 Physiological 2

signal

amplifier

882.1845 Physiological 2

signal

conditioner

882.1855 Electroencephalo 2

gram (EEG)

telemetry

system

882.5050 Biofeedback 2

device

Echoencephalo 882.1240 Echoencephalogra 2

graphy ph

RPG 882.4400 Radiofrequency 2

lesion

generator

Neuro Surgery none Electrode, 2

spinal epidural

882.4305 Powered compound 2

cranial drills,

burrs,

trephines, and

their

accessories

882.4310 Powered simple 2

cranial drills

burrs,

trephines, and

their

accessories

882.4360 Electric cranial 2

drill motor

882.4370 Pneumatic 2

cranial drill

motor

882.4560 Stereotaxic 2

instrument

882.4725 Radiofrequency 2

lesion probe

882.4845 Powered rongeur 2

882.5500 Lesion 2

temperature

monitor

Stimulators 882.1870 Evoked response 2

electrical

stimulator

882.1880 Evoked response 2

mechanical

stimulator

882.1890 Evoked response 2

photic

stimulator

882.1900 Evoked response 2

auditory

stimulator

882.1950 Tremor 2

transducer

882.5890 Transcutaneous 2

electrical

nerve

stimulator for

pain relief

Obstetrics/

Gynecology Panel

Fetal 884.1660 Transcervical 2

Monitoring endoscope

(amnioscope)

and accessories

884.1690 Hysteroscope and 2

accessories

(for

performance

standards)

884.2225 Obstetric- 2

gynecologic

ultrasonic

imager

884.2600 Fetal cardiac 2

monitor

884.2640 Fetal 2

phonocardiograp

hic monitor and

accessories

884.2660 Fetal ultrasonic 2

monitor and

accessories

884.2675 Fetal scalp 1

circular

(spiral)

electrode and

applicator

884.2700 Intrauterine 2

pressure

monitor and

accessories

884.2720 External uterine 2

contraction

monitor and

accessories

884.2740 Perinatal 2

monitoring

system and

accessories

884.2960 Obstetric 2

ultrasonic

transducer and

accessories

Gynecological 884.1720 Gynecologic 2

Surgery laparoscope and

Equipment accessories

884.4160 Unipolar 2

endoscopic

coagulator-

cutter and

accessories

884.4550 Gynecologic 2

surgical laser

884.4120 Gynecologic 2

electrocautery

and accessories

884.5300 Condom 2

Ophthalmic 886.3320 Eye sphere 2

Implants implant

Contact Lens 886.1385 Polymethylmethac 2

rylate (PMMA)

diagnostic

contact lens

886.5916 Rigid gas 2

permeable

contact lens

(daily wear

only)

Diagnostic 886.1120 Opthalmic camera 1

Equipment

886.1220 Corneal 1

electrode

886.1250 Euthyscope (AC- 1

powered)

886.1360 Visual field 1

laser

instrument

[[Page 17766]]

886.1510 Eye movement 1

monitor

886.1570 Ophthalmoscope 1

886.1630 AC-powered 1

photostimulator

886.1640 Ophthalmic 1

preamplifier

886.1670 Ophthalmic 2

isotope uptake

probe

886.1780 Retinoscope (AC- 1

powered device)

886.1850 AC-powered slit 1

lamp

biomicroscope

886.1930 Tonometer and 2

accessories

886.1945 Transilluminator 1

(AC-powered

device)

886.3130 Ophthalmic 2

conformer

(Diagnostic/ 886.4670 Phacofragmentati 2

Surgery on system

Equipment)

Ophthalmic 886.3340 Extraocular 2

Implants orbital implant

886.3800 Scleral shell 2

Surgical 880.5725 Infusion pump 2

Equipment (performance

standards)

886.3100 Ophthalmic 2

tantalum clip

886.3300 Absorbable 2

implant

(scleral

buckling

method)

886.4100 Radiofrequency 2

electrosurgical

cautery

apparatus

886.4115 Thermal cautery 2

unit

886.4150 Vitreous 2

aspiration and

cutting

instrument

886.4170 Cryophthalmic 2

unit

886.4250 Ophthalmic 1

electrolysis

unit (AC-

powered device)

886.4335 Operating 1

headlamp (AC-

powered device)

886.4390 Ophthalmic laser 2

886.4392 Nd:YAG laser for 2

posterior

capsulotomy

886.4400 Electronic metal 1

locator

886.4440 AC-powered 1

magnet

886.4610 Ocular pressure 2

applicator

886.4690 Ophthalmic 2

photocoagulator

886.4790 Ophthalmic 2

sponge

886.5100 Ophthalmic beta 2

radiation

source

none Ophthalmoscopes, 1

replacement

batteries, hand-

held

Orthopedic Panel

Implants 888.3010 Bone fixation 2

cerclage

888.3020 Intramedullary 2

fixation rod

888.3030 Single/multiple 2

component

metallic bone

fixation

appliances and

accessories

888.3040 Smooth or 2

threaded

metallic bone

fixation

fastener

888.3050 Spinal 2

interlaminal

fixation

orthosis

888.3060 Spinal 2

intervertebral

body fixation

orthosis

Surgical 888.1240 AC-powered 2

Equipment dynamometer

888.4580 Sonic surgical 2

instrument and

accessories/

attachments

none Accessories, 2

fixation,

spinal

interlaminal

none Accessories, 2

fixation,

spinal

intervertebral

body

none Monitor, 1

pressure,

intracompartmen

tal

none Orthosis, 2

fixation,

spinal

intervertebral

fusion

none Orthosis, spinal

pedicle

fixation

none System, cement 1

removal

extraction

[[Page 17767]]

Physical Medicine

Panel

Diagnostic 890.1225 Chronaximeter 2

Equipment or

(Therapy)

Therapeutic

Equipment

890.1375 Diagnostic 2

electromyograph

890.1385 Diagnostic 2

electromyograph

needle

electrode

890.1450 Powered reflex 2

hammer

890.1850 Diagnostic 2

muscle

stimulator

or (Therapy) 890.5850 Powered muscle 2

stimulator

Therapeutic 890.5100 Immersion 2

Equipment hydrobath

890.5110 Paraffin bath 2

890.5500 Infrared lamp 2

890.5720 Water 2

circulating hot

or cold pack

890.5740 Powered heating 2

pad

Radiology Panel

MRI 892.1000 Magnetic 2

resonance

diagnostic

device

Ultrasound 884.2660 Fetal ultrasonic 2

Diagnostic monitor and

accessories

892.1540 Nonfetal

ultrasonic

monitor

892.1560 Ultrasonic 2

pulsed echo

imaging system

892.1570 Diagnostic 2

ultrasonic

transducer

892.1550 Ultrasonic

pulsed doppler

imaging system

Angiographic 892.1600 Angiographic x- 2

ray system

Diagnostic X- 892.1610 Diagnostic x-ray 2

Ray beam-limiting

device

892.1620 Cine or spot 2

fluorographic x-

ray camera

892.1630 Electrostatic x- 2

ray imaging

system

892.1650 Image- 2

intensified

fluoroscopic x-

ray system

892.1670 Spot film device 2

892.1680 Stationary x-ray 2

system

892.1710 Mammographic x- 2

ray system

892.1720 Mobile x-ray 2

system

892.1740 Tomographic x- 1

ray system

892.1820 Pneumoencephalog 2

raphic chair

892.1850 Radiographic 1

film cassette

892.1860 Radiographic 1

film/cassette

changer

892.1870 Radiographic 2

film/cassette

changer

programmer

892.1900 Automatic 2

radiographic

film processor

892.1980 Radiologic table 1

CT Scanner 892.1750 Computed 2

tomography x-

ray system

Radiation 892.5050 Medical charged- 2

Therapy particle

radiation

therapy system

892.5300 Medical neutron 2

radiation

therapy system

892.5700 Remote 2

controlled

radionuclide

applicator

system

892.5710 Radiation 2

therapy beam-

shaping block

892.5730 Radionuclide 2

brachytherapy

source

892.5750 Radionuclide 2

radiation

therapy system

892.5770 Powered 2

radiation

therapy patient

support

assembly

892.5840 Radiation 2

therapy

simulation

system

892.5930 Therapeutic x- 1

ray tube

housing

assembly

Nuclear 892.1170 Bone 2

Medicine densitometer

892.1200 Emission 2

computed

tomography

system

[[Page 17768]]

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