FDA Approval

Microneedling FDA Clearance

Microneedling FDA Clearance Microneedling FDA Clearance has been granted to Esthetic Education LLC for its SkinStylus SteriLock MicroSystem (K200044). Esthetic Education is among the very…

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510(k) Transfer of Ownership

510(k) Transfer of Ownership A 510(k) for a medical device can be thought of as like a patent making a 510(k) transfer of ownership, say…

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FDA Embargo

FDA Embargo FDA embargos typically refer to state embargos since this is not an enforcement tool used by FDA or allowed under the Food Drug…

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510(k) Process

510(k) Process There are many questions about the 510(k) process, but none is more common than, “how long does it take?” The stock answer of…

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FDA Approved Meaning

FDA Approved Meaning One of the most frequently asked questions by clients and the public alike is what FDA approved means. The difficulty is there…

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CBD

Cannabidiol or CBD, is a common ingredient seen in a lot of products, especially dietary supplements. But what is the regulatory status of CBD? This…

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Hemp GRAS

The FDA recognized Hemp as GRAS today. The FDA Atty law firm worked with Fresh Hemp Foods Ltd. (Manitoba Harvest) to file GRN 000765, GRN…

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Microneedling 510(k)

Microneedling 510(k) The first microneedling 510(k) has been filed following the formal issuance of the Microneedling Classification Order this summer (link to Classification Order here). The…

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Microneedling Update

Microneedling Update The FDA formally issued a Microneedling Classification Order on Friday (link here). Unlike before, the Final Order is now codified in the Code of Federal…

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FDA FSVP

FDA FSVP FDA FSVP and FSMA Enforcement Update Marc recently attended the Food and Drug Law Annual conference as a speaker alongside FDA’s interim director…

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Microneedling Classification Order

Microneedling Classification Order The FDA issued a Microneedling Classification Order that will fundamentally reshape how microneedling devices are sold and used. The classification order (link here) was…

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FDA Homeopathic Drugs

FDA Homeopathic Drugs FDA Homeopathic Drugs are subject to a new enforcement policy that could lead to big changes. Current homeopathic drugs are the subject…

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