[Federal Register Volume 61, Number 248 (Tuesday, December 24, 1996)]
[Rules and Regulations]
[Pages 67713-67715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32550]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 884
[Docket No. 95N-0139]
Medical Devices; Reclassification and Exemption From Premarket
Notification for Certain Classified Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is reclassifying
scented or scented deodorized menstrual pads from class II into class I
based on new information respecting such device. FDA is also exempting
this device, and one already classified generic type of class I device,
unscented menstrual pads, from the requirement of premarket
notification, with limitations. FDA has determined that manufacturers'
submissions of premarket notifications for these devices are
unnecessary for the protection of the public health and that the
agency's review of such submissions will not advance its public health
mission. These exemptions allow the agency to make better use of its
resources and thus better serve the public.
DATES: Effective February 24, 1997. Beginning on February 24, 1997, all
device manufacturers who have 510(k) submissions pending FDA review for
devices falling within a generic category that is subject to this rule,
will receive a letter stating that the device is exempt from the
premarket notification requirements of the Federal Food, Drug, and
Cosmetic Act.
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 July 28, 1995 (60 FR 38902), FDA issued
a proposed rule to reclassify 112 generic types of class II devices
into class I based on new information respecting such devices and to
exempt the 112 generic types of devices, and 12 already classified
generic types of class I devices, from the requirement of premarket
notification, with limitations. Interested persons were given until
October 11, 1995, to comment on the proposed rule.
In the Federal Register of January 16, 1996 (61 FR 1117), FDA
issued a final rule reclassifying 111 of the 112 generic
[[Page 67714]]
types of class II devices included in the July 28, 1995, proposed rule
into class I and exempting 111 of them, and 11 of the already
classified generic types of class I devices from the requirement of
premarket notification, with limitations. In the preamble to the final
rule, the agency stated the following: (1) FDA was deferring action on
scented or scented deodorized menstrual pads (Sec. 884.5425 (21 CFR
884.5425)) and unscented menstrual pads (Sec. 884.5435 (21 CFR
884.5435)) in order to review the comments more closely and to
reevaluate whether the devices should be reclassified and/or exempted
from the requirement of premarket notification, with limitations; (2)
FDA was considering the comments requesting FDA to add 18 additional
devices to the list of devices that the agency was reclassifying into
class I and/or exempting from the requirement of premarket
notification; (3) FDA was considering expanding the reclassification
and exemption for the endoscope and accessories to include additional
endoscope accessories; and (4) FDA would address all these comments in
a future issue of the Federal Register.
During the comment period, FDA received three comments questioning
the appropriateness of the proposed reclassification and exemption for
scented or scented deodorized menstrual pads (Sec. 884.5425) and the
proposed exemption for unscented menstrual pads (Sec. 884.5435).
After careful review of the comments and reconsideration of the
appropriateness of the proposed reclassification and exemption for
scented or scented deodorized menstrual pads (Sec. 884.5425) and the
proposed exemption for unscented menstrual pads (Sec. 884.5435), the
agency has decided to revise: (1) The limitation placed upon the
proposed reclassification into class I; (2) the exemptions from the
requirement of premarket notification; and (3) the proposed
requirements for safety testing.
FDA will address the comments regarding the other devices included
in the July 28, 1995, proposed rule in a future issue of the Federal
Register.
Three comments questioned the appropriateness of the proposed
reclassification and exemption for scented or scented deodorized
menstrual pads (Sec. 884.5425) and the proposed exemption for unscented
menstrual pads (Sec. 884.5435). All three comments requested that the
``made from cotton or rayon'' limitation placed upon the proposed
reclassification into class I and the exemption from the requirement of
premarket notification be eliminated or revised to provide for a wider
range of materials that are currently in use. In addition, two of the
comments said that the proposed requirements for safety testing were
inappropriate and unnecessary.
The agency has decided to revise the limitation placed upon the
reclassification and exemption for scented or scented deodorized
menstrual pads (Sec. 884.5425) into class I and the exemption for
unscented menstrual pads (Sec. 884.5435). FDA has concluded, based on
new information that, when these devices are made of common cellulosic
and synthetic material with an established safety profile, general
controls will provide reasonable assurance of the safety and
effectiveness of these devices. Finally, FDA has concluded that the
exemption for class I scented or scented deodorized menstrual pads
(Sec. 884.5425) and unscented menstrual pads (Sec. 884.5435) will be
limited and would apply only to menstrual pads made of common
cellulosic and synthetic material with an established safety profile.
For the two devices for which exemptions are being granted, FDA has
concluded that manufacturers' submissions of premarket notifications
are unnecessary for the protection of the public health and that the
agency's review of such submissions will not advance its public health
mission.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(2) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IV. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).
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. Because this final rule would reduce the regulatory
burden for all manufacturers of menstrual pads covered by this rule,
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 in 21 CFR Part 884
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, and
redelegated to the Director of the Center for Devices and Radiological
Health, 21 CFR part 884 is amended as follows:
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
1. 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).
2. Section 884.5425 is amended by revising paragraph (b) to read as
follows:
Sec. 884.5425 Scented or scented deodorized menstrual pad.
* * * * *
(b) Classification. (1) Class I (general controls) for menstrual
pads made of common cellulosic and synthetic material with an
established safety profile. The devices subject to this paragraph
(b)(1) are exempt from the premarket notification procedures in subpart
E of part 807 of this chapter. This exemption does not include the
intralabial pads and reusable menstrual pads.
(2) Class II (special controls) for scented or scented deodorized
menstrual pads made of materials not described in paragraph (b)(1).
3. Section 884.5435 is amended by revising paragraph (b) to read as
follows:
Sec. 884.5435 Unscented menstrual pad.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter only when the device is made of common cellulosic
and synthetic material with an established safety
[[Page 67715]]
profile. This exemption does not include the intralabial pads and
reusable menstrual pads.
Dated: December 16, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-32550 Filed 12-23-96; 8:45 am]
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