Medical Devices; Effective Date of Requirement for Premarket Approval for Class III Preamendments Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 868, 870, 872, 876, 880, 882, 884, 888, and 890

[Docket No. 95N-0084]

RIN 0910-AA31

Medical Devices; Effective Date of Requirement for Premarket

Approval for Class III Preamendments Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final

rule to require the filing of a premarket approval application (PMA) or

a notice of completion of product development protocol (PDP) for 41

class III medical devices. The agency has summarized its findings

regarding the degree of risk of illness or injury designed to be

eliminated or reduced by requiring the devices to meet the statute's

approval requirements and the benefits to the public from the use of

the devices.

EFFECTIVE DATE: September 27, 1996.

FOR FURTHER INFORMATION CONTACT: Melpomeni K. Jeffries, Center for

Devices and Radiological Health (HFZ-404), Food and Drug

Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-

2186.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of May 6, 1994 (59 FR 23731), FDA issued a

notice of availability of a preamendments class III devices strategy

document. The strategy document set forth FDA's plans for implementing

the provisions of section 515(i) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 360e(i)) for preamendments class III

devices for which FDA had not yet required premarket approval. FDA

divided the devices into three groups as referenced in the May 6, 1994,

notice.

[[Page 50705]]

In the Federal Register of September 7, 1995 (60 FR 46718), FDA

published a proposed rule to require the filing under section 515(b) of

the act of a PMA or a notice of completion of a PDP for 43 class III

medical devices. In accordance with section 515(b)(2)(A) of the act,

FDA included in the preamble to the proposal the agency's proposed

findings with respect to the degree of risk of illness or injury

designed to be eliminated or reduced by requiring the device to meet

the premarket approval requirements of the act, and the benefits to the

public from use of the device (60 FR 46718 at 46743). The September 7,

1995, proposed rule also provided an opportunity for interested persons

to submit comments on the proposed rule and the agency's proposed

findings. Under section 515(b)(2)(B) of the act, FDA provided an

opportunity for interested persons to request a change in the

classification of the device based on new information relevant to its

classification. Any petition requesting a change in the classification

of the 43 class III devices was required to be submitted by September

22, 1995. The comment period closed on January 5, 1996.

FDA received two citizens petitions requesting a change in the

classification for the Automated Cell Counting Devices and the

Obstetric Data Analyzer from class III to class II or I. FDA reviewed

the petitions and identified the deficiencies in each one and followed

up with a deficiency letter on January 16, 1996, for the Automated Cell

Counting Devices, and on March 7, 1996, for the Obstetric Data

Analyzer. FDA will make a decision on whether to finalize the rule to

require PMA's for these devices after reviewing any additional

information submitted in support of reclassification.

II. Findings With Respect to Risks and Benefits

Under section 515(b)(3) of the act, FDA is adopting the findings as

published in the proposed rule of September 7, 1995. As required by

section 515(b) of the act, FDA published its findings regarding: (1)

The degree of risk of illness or injury designed to be eliminated or

reduced by requiring that these devices have an approved PMA or a

declared completed PDP; and (2) the benefits to the public from the use

of the device.

These findings are based on the reports and recommendations of the

advisory committees (panels) for the classification of these devices

along with any additional information that FDA discovered. Additional

information can be found in the proposed and final rules classifying

these devices as listed below:

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

Devices Proposed rule Final rule

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

Anesthesiology 1982 (21 CFR part November 2, 1979 July 16, 1982 (47

868). (44 FR 63292). FR 31130).

Cardiovascular (21 CFR part 870) March 9, 1979 (44 February 5, 1980

FR 13284). (45 FR 7904).

Dental (21 CFR part 872)........ December 30, 1980 August 12, 1987

(45 FR 85962). (52 FR 30082).

Gastroenterology-Urology (21 CFR January 23, 1981 November 23, 1983

part 876). (46 FR 7562). (48 FR 53012).

General Hospital and Personal August 24, 1979 October 21, 1980

Use (21 CFR part 880). (44 FR 49844). (45 FR 69678).

Neurological (21 CFR part 882).. November 28, 1978 September 4, 1979

(43 FR 55640). (44 FR 51726).

Obstetrical and Gynecological... April 3, 1979 (44 February 26, 1980

FR 19894). (45 FR 12682).

Orthopedic (21 CFR part 888).... July 2, 1982 (47 September 4, 1987

FR 29052). (52 FR 33686).

Physical Medicine (21 CFR part August 28, 1979 November 23, 1983

890). (44 FR 50458). (48 FR 53032).

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

III. Final Rule

Under section 515(b)(3) of the act, FDA is adopting the findings as

published in the preamble to the proposed rule and is issuing this

final rule to require premarket approval of the generic type of devices

for class III preamendments devices by revising parts 868, 870, 872,

876, 880, 882, 884, 888, and 890 (21 CFR parts 868, 870, 872, 876, 880,

882, 884, 888, and 890).

Under the final rule, a PMA or a notice of completion of a PDP is

required to be filed with FDA within 90 days of the effective date of

this regulation for any of these class III preamendment devices that

were in commercial distribution before May 28, 1976, or any device that

FDA has found to be substantially equivalent to such a device on or

before December 26, 1996. An approved PMA or declared completed PDP is

required to be in effect for any such device on or before 180 days

after FDA files the application. Any other class III preamendment

device subject to this rule that was not in commercial distribution

before May 28, 1976, or that FDA has not found, on or before December

26, 1996, to be substantially equivalent to any class III preamendment

device that was in commercial distribution before May 28, 1976, is

required to have an approved PMA or declared completed PDP in effect

before it may be marketed.

If a PMA or notice of completion of a PDP for any of these class

III preamendment devices is not filed on or before December 26, 1996,

that device will be deemed adulterated under section 501(f)(1)(A) of

the act (21 U.S.C. 351(f)(1)(A)), and commercial distribution of the

device will be required to cease immediately. The device may, however,

be distributed for investigational use, if the requirements of the

investigational device exemption (IDE) regulations (part 812 (21 CFR

part 812)) are met.

Under Sec. 812.2(d) of the IDE regulations, FDA hereby stipulates

that the exemptions from the IDE requirements in Sec. 812.2(c)(1) and

(c)(2) will no longer apply to clinical investigations of these class

III preamendment devices. Further, FDA concludes that investigational

class III preamendment devices subject to this rule are significant

risk devices as defined in Sec. 812.3(m) and advises that as of the

effective date of parts 868, 870, 872, 876, 880, 882, 884, 888, and 890

requirements of the IDE regulations regarding significant risk devices

will apply to any clinical investigation of these class III

preamendment devices. For any of these class III preamendment devices

that is not subject to a timely filed PMA or notice of completion of a

PDP or notice of completion of a PDP, an IDE must be in effect under

Sec. 812.20 on or before December 26, 1996, or distribution of the

device for investigational purposes must cease. FDA advises all persons

currently sponsoring a clinical investigation involving any of these

class III preamendment devices to submit an IDE application to FDA no

later than 60 days after the effective date of this regulation, to

avoid the interruption of ongoing investigations.

IV. Environmental Impact

The agency has determined under 21 CFR 25.24(a)(8) and (e)(4) 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.

[[Page 50706]]

V. Analysis of Impacts

FDA has examined the impacts of the final rule under Executive

Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).

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 agency believes that

this final rule is consistent with the regulatory philosophy and

principles identified in the Executive Order. In addition, the final

rule is not a significant regulatory action as defined by the Executive

Order and so is not subject to review under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities. As noted above, FDA published a notice of

availability of a preamendments strategy, which identified these

devices as ones that FDA believed were no longer being marketed.

Following publication of that notice and following publication of the

proposed rule upon which this final rule is based, FDA did not receive

any comments stating that there was any interest in marketing these 41

devices. Therefore, the agency certifies that the final rule will not

have a significant economic impact on a substantial number of small

entities. Therefore, under the Regulatory Flexibility Act, no further

analysis is required.

List of Subjects

21 CFR Parts 868, 870, 872, 876, 880, 882, 884, 888, and 890

Medical devices.

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

authority delegated to the Commissioner of Food and Drugs, 21 CFR parts

868, 870, 872, 876, 880, 882, 884, 888, and 890 are amended as follows:

PART 868--ANESTHESIOLOGY DEVICES

1. The authority citation for 21 CFR part 868 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

2. Section 868.5400 is amended by revising paragraph (c) to read as

follows:

Sec. 868.5400 Electroanesthesia apparatus.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

notice of completion of a PDP is required to be filed with the Food and

Drug Administration on or before December 26, 1996 for any

electroanesthesia apparatus that was in commercial distribution before

May 28, 1976, or that has, on or before December 26, 1996 been found to

be substantially equivalent to an electroanesthesia apparatus that was

in commercial distribution before May 28, 1976. Any other

electroanesthesia apparatus shall have an approved PMA or a declared

completed PDP in effect before being placed in commercial distribution.

PART 870--CARDIOVASCULAR DEVICES

3. The authority citation for 21 CFR part 870 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

4. Section 870.1350 is amended by revising paragraph (c) to read as

follows:

Sec. 870.1350 Catheter balloon repair kit.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

notice of completion of a PDP is required to be filed with the Food and

Drug Administration on or before December 26, 1996 for any catheter

balloon repair kit that was in commercial distribution before May 28,

1976, or that has, on or before December 26, 1996 been found to be

substantially equivalent to a catheter balloon repair kit that was in

commercial distribution before May 28, 1976. Any other catheter balloon

repair kit shall have an approved PMA or a declared completed PDP in

effect before being placed in commercial distribution.

5. Section 870.1360 is amended by revising paragraph (c) to read as

follows:

Sec. 870.1360 Trace microsphere.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

notice of completion of a PDP is required to be filed with the Food and

Drug Administration on or before December 26, 1996 for any trace

microsphere that was in commercial distribution before May 28, 1976, or

that has, on or before December 26, 1996 been found to be substantially

equivalent to a trace microsphere that was in commercial distribution

before May 28, 1976. Any other trace microsphere shall have an approved

PMA or a declared completed PDP in effect before being placed in

commercial distribution.

6. Section 870.3850 is amended by revising paragraph (c) to read as

follows:

Sec. 870.3850 Carotid sinus nerve stimulator.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any carotid

sinus nerve stimulator that was in commercial distribution before May

28, 1976, or that has, on or before December 26, 1996 been found to be

substantially equivalent to a carotid sinus nerve stimulator that was

in commercial distribution before May 28, 1976. Any other carotid sinus

nerve stimulator shall have an approved PMA or a declared completed PDP

in effect before being placed in commercial distribution.

7. Section 870.5300 is amended by revising paragraph (c) to read as

follows:

Sec. 870.5300 DC-defibrillator (including paddles).

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any DC-

defibrillator (including paddles) described in paragraph (b)(1) of this

section that was in commercial distribution before May 28, 1976, or

that has, on or before December 26, 1996 been found to be substantially

equivalent to a DC-defibrillator (including paddles) described in

paragraph (b)(1) of this section that was in commercial distribution

before May 28, 1976. Any other DC-defibrillator (including paddles)

described in paragraph (b)(1) of this section shall have an approved

PMA or declared completed PDP in effect before being placed in

commercial distribution.

PART 872--DENTAL DEVICES

8. The authority citation for 21 CFR part 872 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

9. Section 872.3400 is amended by revising paragraph (c) to read

as follows:

Sec. 872.3400 Karaya and sodium borate with or without acacia denture

adhesive.

* * * * *

[[Page 50707]]

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any karaya

and sodium borate with or without acacia denture adhesive that was in

commercial distribution before May 28, 1976, or that has, on or before

December 26, 1996 been found to be substantially equivalent to a karaya

and sodium borate with or without acacia denture adhesive that was in

commercial distribution before May 28, 1976. Any other karaya and

sodium borate with or without acacia denture adhesive shall have an

approved PMA or a declared completed PDP in effect before being placed

in commercial distribution.

10. Section 872.3420 is amended by revising paragraph (c) to read

as follows:

Sec. 872.3420 Carboxymethylcellulose sodium and cationic

polyacrylamide polymer denture adhesive.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any

carboxymethylcellulose sodium and cationic polyacrylamide polymer

denture adhesive that was in commercial distribution before May 28,

1976, or that has, on or before December 26, 1996 been found to be

substantially equivalent to a carboxymethylcellulose sodium and

cationic polyacrylamide polymer denture adhesive that was in commercial

distribution before May 28, 1976. Any other carboxymethylcellulose

sodium and cationic polyacrylamide polymer denture adhesive shall have

an approved PMA or a declared completed PDP in effect before being

placed in commercial distribution.

11. Section 872.3480 is amended by revising paragraph (c) to read

as follows:

Sec. 872.3480 Polyacrylamide polymer (modified cationic) denture

adhesive.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any

polyacrylamide polymer (modified cationic) denture adhesive that was in

commercial distribution before May 28, 1976, or that has, on or before

December 26, 1996 been found to be substantially equivalent to a

polyacrylamide polymer (modified cationic) denture adhesive that was in

commercial distribution before May 28, 1976. Any other polyacrylamide

polymer (modified cationic) denture adhesive shall have an approved PMA

or a declared completed PDP in effect before being place in commercial

distribution.

12. Section 872.3500 is amended by revising paragraph (c) to read

as follows:

Sec. 872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid

copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any

polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and

carboxymethylcellulose sodium (NACMC) denture adhesive that was in

commercial distribution before May 28, 1976, or that has, on or before

December 26, 1996 been found to be substantially equivalent to a

polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and

carboxymethylcellulose sodium (NACMC) denture adhesive that was in

commercial distribution before May 28, 1976. Any other

polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and

carboxymethylcellulose sodium (NACMC) denture adhesive shall have an

approved PMA or a declared completed PDP in effect before being placed

in commercial distribution.

13. Section 872.3560 is amended by revising paragraph (c) to read

as follows:

Sec. 872.3560 OTC denture reliner.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any OTC

denture reliner that was in commercial distribution before May 28,

1976, or that has, on or before December 26, 1996 been found to be

substantially equivalent to an OTC denture reliner that was in

commercial distribution before May 28, 1976. Any other OTC denture

reliner shall have an approved PMA or a declared completed PDP in

effect before being placed in commercial distribution.

14. Section 872.3820 is amended by revising paragraph (c) to read

as follows:

Sec. 872.3820 Root canal filling resin.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any root

canal filling resin described in paragraph (b)(2) of this section that

was in commercial distribution before May 28, 1976, or that has, on or

before December 26, 1996 been found to be substantially equivalent to a

root canal filling resin described in paragraph (b)(2) of this section

that was in commercial distribution before May 28, 1976. Any other root

canal filling resin shall have an approved PMA or a declared completed

PDP in effect before being placed in commercial distribution.

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

15. The authority citation for 21 CFR part 876 is revised to read

as follows:

Authority: Secs. 501, 510, 513, 515, 520, 522, 701 of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c,

360e, 360j, 360l, 371).

16. Section 876.5220 is amended by revising paragraph (c) to read

as follows:

Sec. 876.5220 Colonic irrigation system.

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any colonic

irrigation system described in paragraph (b)(2) of this section that

was in commercial distribution before May 28, 1976, or that has, on or

before December 26, 1996 been found to be substantially equivalent to a

colonic irrigation system described in paragraph (b)(2) of this section

that was in commercial distribution before May 28, 1976. Any other

colonic irrigation system shall have an approved PMA in effect before

being placed in commercial distribution.

17. Section 876.5270 is amended by revising paragraph (c) to read

as follows:

Sec. 876.5270 Implanted electrical urinary continence device.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any

implanted electrical urinary continence device that was in commercial

distribution before May 28, 1976, or that has, on or before December

26, 1996 been found to be substantially equivalent to an implanted

electrical urinary continence device that was in commercial

distribution before May 28, 1976. Any other implanted electrical

urinary continence device shall have an approved PMA or a declared

completed

[[Page 50708]]

PDP in effect before being placed in commercial distribution.

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

18. The authority citation for 21 CFR part 880 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

19. Section 880.5760 is amended by revising paragraph (c) to read

as follows:

Sec. 880.5760 Chemical cold pack snakebite kit.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any chemical

cold pack snakebite kit that was in commercial distribution before May

28, 1976, or that has, on or before December 26, 1996 been found to be

substantially equivalent to a chemical cold pack snakebite kit that was

in commercial distribution before May 28, 1976. Any other chemical cold

pack snakebite kit shall have an approved PMA or a declared completed

PDP in effect before being placed in commercial distribution.

PART 882--NEUROLOGICAL DEVICES

20. The authority citation for 21 CFR part 882 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

21. Section 882.1825 is amended by revising paragraph (c) to read

as follows:

Sec. 882.1825 Rheoencephalograph.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any

rheoencephalograph that was in commercial distribution before May 28,

1976, or that has, on or before December 26, 1996 been found to be

substantially equivalent to a rheoencephalograph that was in commercial

distribution before May 28, 1976. Any other rheoencephalograph shall

have an approved PMA or a declared completed PDP in effect before being

placed in commercial distribution.

22. Section 882.5150 is amended by revising paragraph (c) to read

as follows:

Sec. 882.5150 Intravascular occluding catheter.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any

intravascular occluding catheter that was in commercial distribution

before May 28, 1976, or that has, on or before December 26, 1996 been

found to be substantially equivalent to an intravascular occluding

catheter that was in commercial distribution before May 28, 1976. Any

other intravascular occluding catheter shall have an approved PMA or a

declared completed PDP in effect before being placed in commercial

distribution.

23. Section 882.5850 is amended by revising paragraph (c) to read

as follows:

Sec. 882.5850 Implanted spinal cord stimulator for bladder

evacuation.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any

implanted spinal cord stimulator for bladder evacuation that was in

commercial distribution before May 28, 1976, or that has, on or before

December 26, 1996 been found to be substantially equivalent to an

implanted spinal cord stimulator for bladder evacuation that was in

commercial distribution before May 28, 1976. Any other implanted spinal

cord stimulator for bladder evacuation shall have an approved PMA or a

declared completed PDP in effect before being placed in commercial

distribution.

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

24. The authority citation for 21 CFR part 884 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

25. Section 884.2620 is amended by revising paragraph (c) to read

as follows:

Sec. 884.2620 Fetal electroencephalographic monitor.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any fetal

electroencephalographic monitor that was in commercial distribution

before May 28, 1976, or that has, on or before December 26, 1996 been

found to be substantially equivalent to a fetal electroencephalographic

monitor in commercial distribution before May 28, 1976. Any other fetal

electroencephalographic monitor shall have an approved PMA or a

declared completed PDP in effect before being placed in commercial

distribution.

26. Section 884.2685 is amended by revising paragraph (c) to read

as follows:

Sec. 884.2685 Fetal scalp clip electrode and applicator.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any fetal

scalp clip electrode and applicator that was in commercial distribution

before May 28, 1976, or that has, on or before December 26, 1996 been

found to be substantially equivalent to a fetal scalp clip electrode

and applicator that was in commercial distribution before May 28, 1976.

Any other fetal scalp clip electrode and applicator shall have an

approved PMA or a declared completed PDP in effect before being placed

in commercial distribution.

27. Section 884.4250 is amended by revising paragraph (c) to read

as follows:

Sec. 884.4250 Expandable cervical dilator.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any

expandable cervical dilator that was in commercial distribution before

May 28, 1976, or that has, on or before December 26, 1996 been found to

be substantially equivalent to an expandable cervical dilator that was

in commercial distribution before May 28, 1976. Any other expandable

cervical dilator shall have an approved PMA or a declared completed PDP

in effect before being placed in commercial distribution.

28. Section 884.4270 is amended by revising paragraph (c) to read

as follows:

Sec. 884.4270 Vibratory cervical dilators.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any

vibratory cervical dilator that was in commercial

[[Page 50709]]

distribution before May 28, 1976, or that has, on or before December

26, 1996 been found to be substantially equivalent to a vibratory

cervical dilator that was in commercial distribution before May 28,

1976. Any other vibratory cervical dilator shall have an approved PMA

or a declared completed PDP in effect before being placed in commercial

distribution.

29. Section 884.5050 is amended by revising paragraph (c) to read

as follows:

Sec. 884.5050 Metreurynter-balloon abortion system.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any

metreurynter-balloon abortion system that was in commercial

distribution before May 28, 1976, or that has, on or before December

26, 1996 been found to be substantially equivalent to a metreurynter-

balloon abortion system that was in commercial distribution before May

28, 1976. Any other metreurynter-balloon abortion system shall have an

approved PMA or a declared completed PDP in effect before being placed

in commercial distribution.

30. Section 884.5225 is amended by revising paragraph (c) to read

as follows:

Sec. 884.5225 Abdominal decompression chamber.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any

abdominal decompression chamber that was in commercial distribution

before May 28, 1976, or that has, on or before December 26, 1996 been

found to be substantially equivalent to an abdominal decompression

chamber that was in commercial distribution before May 28, 1976. Any

other abdominal decompression chamber shall have an approved PMA or a

declared completed PDP in effect before being placed in commercial

distribution.

PART 888--ORTHOPEDIC DEVICES

31. The authority citation for 21 CFR part 888 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c,360e, 360j,

371).

32. Section 888.3120 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3120 Ankle joint metal/polymer non-constrained cemented

prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any ankle

joint metal/polymer non-constrained cemented prosthesis that was in

commercial distribution before May 28, 1976, or that has, on or before

December 26, 1996, been found to be substantially equivalent to a ankle

joint metal/polymer non-constrained cemented prosthesis that was in

commercial distribution before May 28, 1976. Any other ankle joint

metal/polymer non-constrained cemented prosthesis shall have an

approved PMA or a declared completed PDP in effect before being placed

in commercial distribution.

33. Section 888.3180 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3180 Elbow joint humeral (hemi-elbow) metallic uncemented

prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any elbow

joint humeral (hemi-elbow) metallic uncemented prosthesis that was in

commercial distribution before May 28, 1976, or that has, on or before

December 26, 1996 been found to be substantially equivalent to an elbow

joint humeral (hemi-elbow) metallic uncemented prosthesis that was in

commercial distribution before May 28, 1976. Any other elbow joint

humeral (hemi-elbow) metallic uncemented prosthesis shall have an

approved PMA or a declared completed PDP in effect before being placed

in commercial distribution.

34. Section 888.3200 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3200 Finger joint metal/metal constrained uncemented

prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any finger

joint metal/metal constrained uncemented prosthesis that was in

commercial distribution before May 28, 1976, or that has, on or before

December 26, 1996 been found to be substantially equivalent to a finger

joint metal/metal constrained uncemented prosthesis that was in

commercial distribution before May 28, 1976. Any other finger joint

metal/metal constrained uncemented prosthesis shall have an approved

PMA or a declared completed PDP in effect before being placed in

commercial distribution.

35. Section 888.3210 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3210 Finger joint metal/metal constrained cemented

prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any finger

joint metal/metal constrained cemented prosthesis that was in

commercial distribution before May 28, 1976, or that has, on or before

December 26, 1996 been found to be substantially equivalent to a finger

joint metal/metal constrained cemented prosthesis that was in

commercial distribution before May 28, 1976. Any other finger joint

metal/metal constrained cemented prosthesis shall have an approved PMA

or a declared completed PDP in effect before being placed in commercial

distribution.

36. Section 888.3220 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3220 Finger joint metal/polymer constrained cemented

prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any finger

joint metal/polymer constrained cemented prosthesis that was in

commercial distribution before May 28, 1976, or that has, on or before

December 26, 1996 been found to be substantially equivalent to a finger

joint metal/polymer constrained cemented prosthesis that was in

commercial distribution before May 28, 1976. Any other finger joint

metal/polymer constrained cemented prosthesis shall have an approved

PMA or a declared completed PDP in effect before being placed in

commercial distribution.

37. Section 888.3300 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3300 Hip joint metal constrained cemented or uncemented

prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any hip

joint metal constrained cemented or uncemented

[[Page 50710]]

prosthesis that was in commercial distribution before May 28, 1976, or

that has, on or before December 26, 1996 been found to be substantially

equivalent to a hip joint metal constrained cemented or uncemented

prosthesis that was in commercial distribution before May 28, 1976. Any

other hip joint metal constrained cemented or uncemented prosthesis

shall have an approved PMA or a declared completed PDP in effect before

being placed in commercial distribution.

38. Section 888.3310 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3310 Hip joint metal/polymer constrained cemented or

uncemented prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any hip

joint metal/polymer constrained cemented or uncemented prosthesis that

was in commercial distribution before May 28, 1976, or that has, on or

before December 26, 1996 been found to be substantially equivalent to a

hip joint metal/polymer constrained cemented or uncemented prosthesis

that was in commercial distribution before May 28, 1976. Any other hip

joint metal/polymer constrained cemented or uncemented prosthesis shall

have an approved PMA or a declared completed PDP in effect before being

placed in commercial distribution.

39. Section 888.3370 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3370 Hip joint (hemi-hip) acetabular metal cemented

prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any hip

joint (hemi-hip) acetabular metal cemented prosthesis that was in

commercial distribution before May 28, 1976, or that has, on or before

December 26, 1996 been found to be substantially equivalent to a hip

joint (hemi-hip) acetabular metal cemented prosthesis that was in

commercial distribution before May 28, 1976. Any other hip joint metal

(hemi-hip) acetabular metal cemented prosthesis shall have an approved

PMA or a declared completed PDP in effect before being placed in

commercial distribution.

40. Section 888.3380 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3380 Hip joint femoral (hemi-hip) trunnion-bearing metal/

polyacetal cemented prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any hip

joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented

prosthesis that was in commercial distribution before May 28, 1976, or

that has, on or before December 26, 1996 been found to be substantially

equivalent to a hip joint femoral (hemi-hip) trunnion-bearing metal/

polyacetal cemented prosthesis that was in commercial distribution

before May 28, 1976. Any other hip joint femoral (hemi-hip) trunnion-

bearing metal/polyacetal cemented prosthesis shall have an approved PMA

or a declared completed PDP in effect before being placed in commercial

distribution.

41. Section 888.3480 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3480 Knee joint femorotibial metallic constrained cemented

prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any knee

joint femorotibial metallic constrained cemented prosthesis that was in

commercial distribution before May 28, 1976, or that has, on or before

December 26, 1996 been found to be substantially equivalent to a knee

joint femorotibial metallic constrained cemented prosthesis that was in

commercial distribution before May 28, 1976. Any other knee joint

femorotibial metallic constrained cemented prosthesis shall have an

approved PMA or a declared completed PDP in effect before being placed

in commercial distribution.

42. Section 888.3540 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3540 Knee joint patellofemoral polymer/metal semi-

constrained cemented prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any knee

joint patellofemoral polymer/metal semi-constrained cemented prosthesis

that was in commercial distribution before May 28, 1976, or that has,

on or before December 26, 1996 been found to be substantially

equivalent to a knee joint patellofemoral polymer/metal semi-

constrained cemented prosthesis that was in commercial distribution

before May 28, 1976. Any other knee joint patellofemoral polymer/metal

semi-constrained cemented prosthesis shall have an approved PMA or a

declared completed PDP in effect before being placed in commercial

distribution.

43. Section 888.3550 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3550 Knee joint patellofemorotibial polymer/metal/metal

constrained cemented prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any knee

joint patellofemorotibial polymer/metal/metal constrained cemented

prosthesis that was in commercial distribution before May 28, 1976, or

that has, on or before December 26, 1996 been found to be substantially

equivalent to a knee joint patellofemorotibial polymer/metal/metal

constrained cemented prosthesis that was in commercial distribution

before May 28, 1976. Any other knee joint patellofemorotibial polymer/

metal/metal constrained cemented prosthesis shall have an approved PMA

or a declared completed PDP in effect before being placed in commercial

distribution.

44. Section 888.3570 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3570 Knee joint femoral (hemi-knee) metallic uncemented

prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any knee

joint femoral (hemi-knee) metallic uncemented prosthesis that was in

commercial distribution before May 28, 1976, or that has, on or before

December 26, 1996 been found to be substantially equivalent to a knee

joint femoral (hemi-knee) metallic uncemented prosthesis that was in

commercial distribution before May 28, 1976. Any other knee joint

femoral (hemi-knee) metallic uncemented prosthesis shall have an

approved PMA or a declared completed PDP in effect before being placed

in commercial distribution.

[[Page 50711]]

45. Section 888.3580 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3580 Knee joint patellar (hemi-knee) metallic resurfacing

uncemented prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any knee

joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis

described in paragraph (b)(2) of this section that was in commercial

distribution before May 28, 1976, or that has, on or before December

26, 1996 been found to be substantially equivalent to a knee joint

patellar (hemi-knee) metallic resurfacing uncemented prosthesis that

was in commercial distribution before May 28, 1976. Any other knee

joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis

shall have an approved PMA or a declared completed PDP in effect before

being placed in commercial distribution.

46. Section 888.3640 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3640 Shoulder joint metal/metal or metal/polymer constrained

cemented prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any shoulder

joint metal/metal or metal/polymer constrained cemented prosthesis that

was in commercial distribution before May 28, 1976, or that has, on or

before December 26, 1996 been found to be substantially equivalent to a

shoulder joint metal/metal or metal/polymer constrained cemented

prosthesis that was in commercial distribution before May 28, 1976. Any

other shoulder joint metal/metal or metal/polymer constrained cemented

prosthesis shall have an approved PMA or a declared completed PDP in

effect before being placed in commercial distribution.

47. Section 888.3680 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3680 Shoulder joint glenoid (hemi-shoulder) metallic

cemented prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any shoulder

joint glenoid (hemi-shoulder) metallic cemented prosthesis that was in

commercial distribution before May 28, 1976, or that has, on or before

December 26, 1996 been found to be substantially equivalent to a

shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis

that was in commercial distribution before May 28, 1976. Any other

shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis

shall have an approved PMA or a declared completed PDP in effect before

being placed in commercial distribution.

48. Section 888.3790 is amended by revising paragraph (c) to read

as follows:

Sec. 888.3790 Wrist joint metal constrained cemented prosthesis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any wrist

joint metal constrained cemented prosthesis that was in commercial

distribution before May 28, 1976, or that has, on or before December

26, 1996 been found to be substantially equivalent to a wrist joint

metal constrained cemented prosthesis that was in commercial

distribution before May 28, 1976. Any other wrist joint metal

constrained cemented prosthesis shall have an approved PMA or a

declared completed PDP in effect before being placed in commercial

distribution.

PART 890--PHYSICAL MEDICINE DEVICES

49. The authority citation for 21 CFR part 890 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

50. Section 890.3610 is amended by revising paragraph (c) to read

as follows:

Sec. 890.3610 Rigid pneumatic structure orthosis.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before December 26, 1996 for any rigid

pneumatic structure orthosis that was in commercial distribution before

May 28, 1976, or that has, on or before December 26, 1996 been found to

be substantially equivalent to a rigid pneumatic structure orthosis

that was in commercial distribution before May 28, 1976. Any other

rigid pneumatic structure orthosis shall have an approved PMA or a

declared completed PDP in effect before being placed in commercial

distribution.

Dated: September 9, 1996.

D.B. Burlington,

Director, Center for Devices and Radiological Health.

[FR Doc. 96-24753 Filed 9-26-96; 8:45 am]

BILLING CODE 4160-01-F