[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]
BILLING CODE 4160-01-F