FDA reclassification of needle epilators The following is edited text of a ruling made by FDA on 16 January
1996, reclassifying the needle epilator device.
The relevant passage is in bold at the end (emphasis
mine).
- [Federal Register: January 16, 1996 (Volume 61, Number 10)]
- [Rules and Regulations]
- [Page 1117-1126]
- From the Federal Register Online via GPO Access [wais.access.gpo.gov]
- [DOCID:fr16ja96-5]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
- Food and Drug Administration
- 21 CFR Parts 862, 866, 868, 870, 872, 874, 876, 878, 880,
882, 884,
- 886, 888, 890, and 892
- [Docket No. 95N-0139]
- RIN 0910-AA65
- Medical Devices; Reclassification and Exemption From Premarket
- Notification for Certain Classified Devices
- AGENCY: Food and Drug Administration, HHS.
- ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is reclassifying
111 generic types of class II devices into class I based on new
information respecting such devices. FDA is also exempting the
111 generic types of devices, and 11 already classified generic
types of class I devices, from the requirement of premarket notification,
with limitations. For the exempted devices, FDA has determined
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. The exemptions allow the agency to make better
use of its resources and thus better serve the public. These devices
will remain subject to current good manufacturing practice (CGMP)
regulations and other general controls. This rulemaking is part
of the President's and Vice President's
Government effort.
DATES: Effective February 15, 1996. Beginning on February 15,
1996, all device manufacturers who have 510(k) submissions pending
FDA review for devices falling within a generic category which
is subject to this rule, will receive a letter stating that the
device is exempt from the premarket notification requirements
of the 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.
II. Comments
During the comment period, FDA received three comments requesting
that various devices be added to the list of devices that the
agency was proposing to reclassify into class I and/or exempt
from the requirement of premarket notification. FDA is considering
these comments and will address them in a future issue of the
Federal Register.
FDA also received a comment stating that the proposed reclassification
and exemption for endoscope and accessories (21 CFR 876.1500)
was too narrow. According to this comment, the reclassification
and exemption for endoscope and accessories should be expanded
to include additional endoscope accessories which the comment
felt meets the reclassification and exemption criteria. FDA is
finalizing the endoscope and accessories reclassification and
exemption as proposed. However, FDA is considering expanding the
reclassification and exemption for endoscope and accessories to
include additional endoscope accessories and FDA will address
this device in a future issue of the Federal Register.
FDA received three comments questioning the appropriateness of
the proposed reclassification and exemption for scented or scented
deodorized menstrual pads (21 CFR 884.5425) and the proposed exemption
for unscented menstrual pads (21 CFR 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 revised. In
addition, two of the comments questioned the proposed requirements
for safety testing. FDA is deferring action on these two devices
in order to review these comments more closely and to reevaluate
whether the devices should be reclassified and/or exempted from
the requirement of premarket notification, with limitations. The
agency will address these devices in a future issue of the Federal
Register.
III. Conclusion
FDA received no comments opposing the reclassification into class
I of 111 of the 112 generic types of devices included in the proposed
rule. Moreover, the agency did not receive comments opposing the
proposed exemption from the requirements of premarket notification
for 111 of these 112 generic types of devices, and 11 already
classified generic types of class I devices. For 111 of the 112
devices proposed for reclassification into class I, the agency
has concluded, based on new information respecting such devices
as described in the proposed rule, that general controls will
provide reasonable assurance of the safety and effectiveness of
these devices. For 122 of the 124 devices for which exemptions
have been proposed (including the 111 device types being reclassified),
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. Thus, FDA is finalizing the
reclassification of 111 devices and the exemption from premarket
notification for 122 devices, including the 111 devices being
reclassified and 11 of the devices already classified in class
I. All of these devices remain subject to CGMP requirements and
other general controls under the statute.
IV. 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 or an environmental impact
statement is required.
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. Because this final rule would reduce a regulatory
burden by exempting manufacturers of devices subject to the rule
from the requirements of premarket notification, 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 862, 868, 870, 872, 874, 876, 878, 880, 882, 884,
888, and 890
Medical devices.
[edit]
Therefore, under the Federal Food, Drug, and Cosmetic Act and
under authority delegated to the Commissioner of Food and Drugs,
21 CFR parts 862, 866, 868, 870, 872, 874, 876, 878, 880, 882,
884, 886, 888, 890, and 892 are amended as follows:
[edit]
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
85. The authority citation for 21 CFR part 878 continues 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).
[edit]
87. Section 878.4810 is amended by revising paragraph (b) to
read as follows:
Sec. 878.4810- Laser surgical instrument for use in general and
plastic surgery and in dermatology.
* * * * *
(b) Classification. (1) Class II.
(2) Class I for special laser gas mixtures used as a lasing medium
for this class of lasers. The devices subject to this paragraph
(b)(2) are exempt from the premarket notification procedures in
subpart E of part 807 of this chapter.
88. Section 878.5350 is amended
by revising paragraph (b) to read as follows:
Sec. 878.5350- Needle-type epilator.
* * * * *
(b) Classification. Class I. The
device is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter.
[edit]
- Dated: January 5, 1996.
- William B. Schultz,
- Deputy Commissioner for Policy.
- [FR Doc. 96-418 Filed 1-11-96; 2:00 pm]
- BILLING CODE 4160-01-F
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