Draft Guidance on Resolving Scientific Disputes Concerning the Regulation of Medical Devices; Administrative Procedures on Use of the Medical Devices Dispute Resolution Panel; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-0239]

Draft Guidance on Resolving Scientific Disputes Concerning the

Regulation of Medical Devices; Administrative Procedures on Use of the

Medical Devices Dispute Resolution Panel; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability of the draft guidance entitled ``Resolving Scientific

Disputes Concerning the Regulation of Medical Devices: An

Administrative Procedures Guide to Use of the Medical Devices Dispute

Resolution Panel.'' Section 404 of the Food and Drug Administration

Modernization Act of 1997 (FDAMA) directed FDA to ensure that it has

effective processes to resolve the scientific disputes that

occasionally arise between FDA and the regulated industry, including a

review by an appropriate panel of experts to advise the agency on

issues upon which industry and FDA professionals differ. This guidance

is neither final nor is it in effect at this time.

DATES: Written comments concerning this guidance must be received by

July 26, 1999. Written comments concerning the information collection

requirements must be received by June 28, 1999.

ADDRESSES: Written comments concerning this guidance must be submitted

to the Dockets Management Branch, (HFA-305), Food and Drug

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Comments should be identified with the docket number found in brackets

in the heading of this document. See the SUPPLEMENTARY INFORMATION

section for information on electronic access to the guidance. Submit

written requests for single copies on a ``3.5'' diskette of the draft

guidance document entitled ``Resolving Scientific Disputes Concerning

the Regulation of Medical Devices: An Administrative Procedures Guide

to Use of the Medical Devices Dispute Resolution Panel'' to the

Division of Small Manufacturers Assistance (HFZ-220), Center for

Devices and Radiological Health, Food and Drug Administration, 1350

Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive

labels to assist that office in processing your request, or fax your

request to 301-443-8818. Submit written comments on the collection of

information requirements to the Dockets Management Branch (address

above). Comments should be identified with the docket number found in

brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: James G. Norman, Center for Devices

and Radiological Health (HFZ-2), Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850, 301-443-4690.

SUPPLEMENTARY INFORMATION:

I. Background

FDA provides various mechanisms by which the device industry can

obtain reconsideration of FDA decisions and actions under the Federal

Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.), the

Administrative Procedure Act (5 U.S.C. 551 et seq.), and agency

regulations. These processes are summarized in a guidance document

entitled ``Medical Device Appeals and Complaints Guidance on Dispute

Resolutions,'' which is available from the CDRH web site at ``http://

www.fda.gov/cdrh/resolvingdisputes''.

Section 404 of FDAMA added to these various mechanisms by

directing FDA to ensure it has effective processes by which a medical

device ``sponsor, applicant, or manufacturer'' can obtain independent

review of a ``scientific controversy'' between that person and FDA. In

the Federal Register of June 16, 1998 (63 FR 32733 and 32772), FDA

published a direct final rule and a companion proposed rule amending

Sec. 10.75 (21 CFR 10.75) to add another method of resolving scientific

controversies. This amendment stated that sponsors, applicants, or

manufacturers of drugs (including human drugs, animal drugs, and human

biologics), or devices may request review of scientific controversies

by an appropriate scientific advisory panel or advisory committee.

(Hereafter in this document, the term advisory committee includes

scientific advisory panels.) By this amendment, FDA clarified that

sponsors, applicants, and manufacturers of drugs, biologics, and

devices are not limited solely to requesting internal supervisory

review, but also have the right to request review of scientific

controversies by appropriate advisory committees. FDA believes that in

appropriate circumstances, advisory committees can provide the agency

with useful insight and advice about the resolution of scientific

controversies.

FDA initially used the direct final rule because it believed the

amendment to Sec. 10.75 was noncontroversial and in accord with FDAMA.

In accordance with FDA's procedures for direct final rulemaking, the

direct final rule stated that if FDA received no significant adverse

comments, the direct final rule would go into effect on October 29,

1998. The direct final rule stated further that if FDA received any

significant adverse comments, it would withdraw the direct final rule

and consider all comments received on the companion proposed rule in

the development of a final rule using the usual notice and comment

rulemaking procedures. The comment period for the companion proposed

rule ended on August 31, 1998. FDA received significant adverse

comments in response to the direct final rule and the companion

proposed rule. Therefore, in the Federal Register of September 23,

1998 (63 FR 50757), FDA withdrew the direct final rule.

Significant adverse comments asserted that the amendment to

Sec. 10.75 failed to provide a procedure that sponsors, applicants, and

manufacturers could follow to request reviews under section 404 of

FDAMA (section 404 reviews). The comments suggested that the regulation

called for by section 404 of FDAMA should contain information such as

the process for selecting members of an advisory committee convened to

conduct a section 404 review, the timeframes for conducting the

reviews, the standards for granting or denying a section 404 review,

and the weight to be given to advisory committee recommendations.

In a final rule issued in the Federal Register on November 18,

1998 (63 FR 63978), FDA acknowledged the usefulness of much of this

kind of information, but concluded that it should not be included in

Sec. 10.75. Because of the significant differences among FDA centers in

applicable statutory provisions, existing appeal and dispute resolution

mechanisms, and approaches to advisory committee management, FDA is

adopting a center-based approach to the implementation of section 404

of FDAMA. Each affected center is responsible for developing and

administering its own processes for handling requests for section 404

reviews and is issuing a guidance document containing specific

information of the type suggested by the comments. The substantive

differences in the programs in the affected centers, and the different

matters that could be

[[Page 22618]]

the subject of a request for advisory committee review, preclude

inclusion of this type of information in Sec. 10.75.

The final rule amended Sec. 10.75 by redesignating paragraph (b)

as paragraph (b)(1) and by adding paragraph (b)(2) to read as follows:

A sponsor, applicant, or manufacturer of a drug or device

regulated under the act or the Public Health Service Act (42 U.S.C.

262), may request review of a scientific controversy by an

appropriate scientific advisory panel as described in section 505(n)

of the act, or an advisory committee as described in section

515(g)(2)(B) of the act. The reason(s) for any denial of a request

for such review shall be briefly set forth in writing to the

requester. Persons who receive a center denial of their request

under this section may submit a request for review of the denial.

The request should be sent to the Chief Mediator and Ombudsman.

To implement the new provision and to comply with Sec. 10.75, as

amended, the Center for Devices and Radiological Health has created the

Medical Devices Dispute Resolution Panel, which will operate under

FDA's Medical Devices Advisory Committee. In addition to serving as a

useful forum in which scientific disputes in general can be aired, the

Medical Devices Dispute Resolution Panel will implement four provisions

of the Federal Food, Drug, and Cosmetic Act:

(1) Section 514(b)(5)(B) of the act requires the establishment of

an advisory committee to take referrals of any matter concerning the

establishment, amendment, or revocation of a performance standard which

requires the exercise of scientific judgment.

(2) Section 515(g)(2)(B) of the act requires the establishment of

an advisory committee to take referrals of petitions for review of:

(a) the approval, denial, or withdrawal of approval of a premarket

approval application, or

(b) the revocation of an approved product development protocol

(PDP), a declaration that an approved PDP has not been completed, or a

revocation of an approved Notice of Completion that permitted marketing

of a device developed under a PDP.

(3) Section 522(b) of the act, which was added by section 212 of

FDAMA, requires a process to resolve any disputes concerning the need

for FDA to order a manufacturer to conduct postmarket surveillance for

more than 36 months.

(4) Section 562 of the act requires FDA to provide a procedure for

review of all scientific disputes regarding the regulation of medical

devices, including review by an appropriate scientific advisory panel,

but only to the extent that other provisions of the act or FDA

regulations do not already provide a right of review. FDA believes its

current procedures already provide methods to obtain review of most, if

not all, scientific disputes. The establishment of the Dispute

Resolution Panel provides an additional, more focused, procedure for

the timely review of scientific disputes.

This draft guidance document sets forth guidelines that will

govern the operation of the Medical Devices Dispute Resolution Panel.

Those guidelines include the appointment of a CDRH Ombudsman, who will

be designated to receive, review, and make recommendations with respect

to requests for review by the resolution panel. CDRH intends to ensure

that a center ombudsman is in place before final guidance goes into

effect.

II. Significance of Guidance

This draft guidance document represents the agency's current

thinking on ``Resolving Scientific Disputes Concerning the Regulation

of Medical Devices: An Administrative Procedures Guide to Use of the

Medical Devices Dispute Resolution Panel.'' It does not create or

confer any rights for or on any person and does not operate to bind FDA

or the public. An alternative approach may be used if such approach

satisfies the applicable statute, regulations, or both.

The agency has adopted Good Guidance Practices (GGP's), which set

forth the agency's policies and procedures for the development,

issuance, and use of guidance documents (62 FR 8961, February 27,

1997). This draft guidance document is issued as a Level 1 guidance,

consistent with GGP's.

III. Electronic Access

In order to receive ``Resolving Scientific Disputes Concerning the

Regulation of Medical Devices: An Administrative Procedures Guide to

Use of the Medical Devices Dispute Resolution Panel'' via your fax

machine, call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or

301-827-0111 from a touch-tone telephone. At the first voice prompt

press 1 to access DSMA Facts, at second voice prompt press 2, and then

enter the document number 1121 followed by the pound sign (#). Then

follow the remaining voice prompts to complete your request.

Persons interested in obtaining a copy of the guidance may also do

so using the World Wide Web (WWW). CDRH maintains an entry on the WWW

for easy access to information including text, graphics, and files that

may be downloaded to a personal computer with access to the WWW.

Updated on a regular basis, the CDRH home page includes ``Resolving

Scientific Disputes Concerning the Regulation of Medical Devices: An

Administrative Procedures Guide to Use of the Medical Devices Dispute

Resolution Panel,'' device safety alerts, Federal Register reprints,

information on pre-market submissions (including lists of approved

applications and manufacturers' addresses), small manufacturers'

assistance, information on video conferencing and electronic

submissions, mammography matters, and other device-oriented

information. The CDRH home page may be accessed at ``http://

www.fda.gov/cdrh''. ``Resolving Scientific Disputes Concerning the

Regulation of Medical Devices: An Administrative Procedures Guide to

Use of the Medical Devices Dispute Resolution Panel'' will be available

at ``http://www.fda.gov/cdrh/resolvingdisputes''.

IV. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.

3501-3520), Federal agencies must obtain approval from the Office of

Management and Budget (OMB) for each collection of information they

conduct or sponsor. ``Collection of information'' is defined in 44

U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or

requirements that members of the public submit reports, keep records,

or provide information to a third party. Section 3506(c)(2)(A) of the

PRA (44 U.S.C. 3506 (c)(2)(A)) requires Federal agencies to provide a

60-day notice in the Federal Register concerning each proposed

collection of information before submitting the collection to OMB for

approval. To comply with this requirement, FDA is publishing notice of

the proposed collection of information set forth below.

With respect to the following collection of information, FDA

invites comments on: (1) Whether the proposed collection of information

is necessary for the proper performance of FDA's functions, including

whether the information will have practical utility; (2) the accuracy

of FDA's estimate of the burden of the proposed collection of

information, including the validity of the methodology and assumptions

used; (3) ways to enhance the quality, utility, and clarity of the

information to be collected; and (4) ways to minimize the burden of the

collection of information on respondents, including through the use of

automated collection techniques, when appropriate, and other forms of

information technology.

[[Page 22619]]

Title: Request for Resolution of Scientific Disputes Concerning the

Regulation of Medical Devices

Description: Section 404 of the Food and Drug Administration

Modernization Act of 1997 (FDAMA) is intended to ensure that FDA has

effective processes to resolve the scientific disputes that

occasionally arise between FDA and the regulated industry. Section 404

added new section 562 of the act which requires FDA to establish, by

regulation, a procedure under which a person who is a sponsor,

applicant, or manufacturer may request a review of a scientific

controversy, when no other provision of the act or regulation provides

such review.

In a final rule issued in the Federal Register on November 18,

1998 (63 FR 63978), FDA amended 21 CFR 10.75 to reflect the provisions

of FDAMA. Each affected FDA center is responsible for developing and

administering its own processes for handling requests for section 404

reviews and is issuing a guidance document containing specific

information of the type suggested by the comments. The draft guidance

document outlines the requirements for persons who are sponsors,

applicants, or manufacturers of medical devices and who wish to file a

request for a review of a scientific dispute by the panel as set out in

the guidance. Persons filing a request for review should provide a CDRH

ombudsman with a concise summary of the scientific issue in dispute,

including a summary of the particular FDA action or decision to which

the requesting party objects, any prior advisory panel action and the

results of all efforts that have been made to resolve the dispute, and

a clear articulated summary of the arguments and relevant data and

information. They may also provide material outside the official

administrative record and not in the possession of FDA at the time the

decision or action in dispute was made if it has a significant bearing

on the issue or related public health considerations. The information

that is collected will form the basis for resolving the dispute between

the requester and FDA.

The likely respondents to this collection of information are

medical device sponsors, applicants, or manufacturers who have a

scientific dispute with FDA and who request a review of the matter by

the Medical Devices Dispute Resolution Panel.

FDA estimates the burden of this collection of information as

follows:

Table 1.--Estimated Annual Reporting Burden1

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Annual

No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

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6............ 1 6 20 120

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\1\ There are no capital costs or operating and maintenance costs

associated with this collection of information.

The Medical Devices Dispute Resolution Panel represents a new

process for resolving scientific disputes. In arriving at the estimates

in Table 1 of this document for the burden imposed in connection with a

request for review by the Medical Devices Dispute Resolution Panel, FDA

considered the number and substance of similar appeals of various types

made to FDA in recent years, knowledge of similar submissions and

discussions with manufacturers.

V. Comments

Interested persons may, on or before July 26, 1999, submit to

Dockets Management Branch (address above) written comments regarding

this draft guidance. 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. Written comments concerning the information collection

requirements must be received by the Dockets Management Branch by June

28, 1999. The guidance document and received comments may be seen in

the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through

Friday.

Dated: March 30, 1999.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center for Devices and

Radiological Health.

[FR Doc. 99-10446 Filed 4-26-99; 8:45 am]

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