Posted 10 November 2020 | By
The US Food and Drug Administration (FDA) on Monday finalized guidance explaining when it considers microneedling devices to be medical devices subject to premarket notification (510(k)) requirements.
The final guidance, which comes more than three years after being released in draft form, has been revised to reflect the classification of microneedling devices for aesthetic use as Class II devices in response to a De Novo classification request for Bellus Medical’s SkinPen. Since issuing the classification order, FDA has cleared several other microneedling devices including Esthetic Education’s Skinstylus Sterilock Microsystem and Refine USA’s Rejuvapen NXT. (RELATED: FDA steps in to regulate microneedling devices, Regulatory Focus 14 September 2017).
“To date, the FDA has only granted marketing authorization for a limited number of medical devices for specific uses in specified areas of the face and body. The FDA may not have reviewed the use of certain microneedling devices for all locations in the body,” FDA explains.
Other than the revisions relating to 510(k) submissions, much of the guidance is the same as the draft version, with some minor clarifications made throughout.
FDA explains that “a microneedling device for aesthetic use is identified as a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use,” and that in general, microneedling products that do not penetrate living skin that are intended for exfoliation or improved skin appearance, smoothness or luminance are not considered medical devices. FDA notes that the guidance does not apply to dermabrasion devices, which are regulated as Class I devices exempt from 510(k) requirements.
For manufacturers that determine their microneedling products are devices, FDA says manufacturers must submit a 510(k) demonstrating substantial equivalence to a legally marketed predicate device, as well as compliance with the special controls laid out in 21 CFR 878.4430 for microneedling devices.
“For a microneedling device that has new or modified indications for use and/or different technological characteristics when compared to the predicate device, FDA may request clinical performance data in addition to non-clinical testing if needed to make a substantial equivalence determination,” FDA writes.
The clinical performance data requested largely mirrors what FDA had specified in the draft guidance for demonstrating a reasonable assurance of safety and efficacy to support a De Novo classification request.
FDA, Federal Register Notice
The final guidance, which comes more than three years after being released in draft form, has been revised to reflect the classification of microneedling devices for aesthetic use as Class II devices in response to a De Novo classification request for Bellus Medical’s SkinPen. Since issuing the classification order, FDA has cleared several other microneedling devices including Esthetic Education’s Skinstylus Sterilock Microsystem and Refine USA’s Rejuvapen NXT. (RELATED: FDA steps in to regulate microneedling devices, Regulatory Focus 14 September 2017).
“To date, the FDA has only granted marketing authorization for a limited number of medical devices for specific uses in specified areas of the face and body. The FDA may not have reviewed the use of certain microneedling devices for all locations in the body,” FDA explains.
Other than the revisions relating to 510(k) submissions, much of the guidance is the same as the draft version, with some minor clarifications made throughout.
FDA explains that “a microneedling device for aesthetic use is identified as a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use,” and that in general, microneedling products that do not penetrate living skin that are intended for exfoliation or improved skin appearance, smoothness or luminance are not considered medical devices. FDA notes that the guidance does not apply to dermabrasion devices, which are regulated as Class I devices exempt from 510(k) requirements.
For manufacturers that determine their microneedling products are devices, FDA says manufacturers must submit a 510(k) demonstrating substantial equivalence to a legally marketed predicate device, as well as compliance with the special controls laid out in 21 CFR 878.4430 for microneedling devices.
“For a microneedling device that has new or modified indications for use and/or different technological characteristics when compared to the predicate device, FDA may request clinical performance data in addition to non-clinical testing if needed to make a substantial equivalence determination,” FDA writes.
The clinical performance data requested largely mirrors what FDA had specified in the draft guidance for demonstrating a reasonable assurance of safety and efficacy to support a De Novo classification request.
FDA, Federal Register Notice
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November 11, 2020 at 05:00AM
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FDA finalizes guidance on microneedling devices | RAPS - Regulatory Focus
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