[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
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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).
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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