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]
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
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.
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.
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.
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
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:
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).
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.
- 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