[Federal Register Volume 61, Number 189 (Friday, September 27, 1996)]
[Rules and Regulations]
[Pages 50704-50711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24753]


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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