The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Regulatory Considerations for Microneedling Devices--Draft Guidance for Industry and Food and Drug Administration Staff.'' This draft guidance is being issued to assist industry in understanding when a microneedling product is a device as defined in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not final nor is it in effect at this time.
Document
Regulatory Considerations for Microneedling Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Regulatory Considerations for Microneedling Devices--Draft Guida...
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82 FR 43383
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“Regulatory Considerations for Microneedling Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,” thefederalregister.org (September 15, 2017), https://thefederalregister.org/documents/2017-19614/regulatory-considerations-for-microneedling-devices-draft-guidance-for-industry-and-food-and-drug-administration-staff-a.