FDA News Update

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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Coronavirus EUA Submission

Coronavirus EUA Submission– Importing N95 Masks and Hand Sanitizers As the novel COVID-19 Coronavirus continues to spread our office has been flooded with Coronavirus EUA…

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FDA Flavor Ban

The FDA flavor ban was announced today through a new Guidance document (link here). It is important to emphasize that this is not a new…

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FDA Vape Ban

FDA Vape Ban The FDA annouced a proposal to ban vape (e-cigarette) flavored products including mint and menthol. The details are just emerging but here’s…

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Out of Date Drug Listings

FDA to deactivate out-of-date drug listings in its database The US Food and Drug Administration (FDA) has announced that it will deactivate out of date…

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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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Plasma Microneedling

Plasma microneedling is a new medical device raising a number of questions. The most common question received is, “is it FDA cleared or FDA approved?”…

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HPHC

HPHC or Harmful and Potentially Harmful Constituents is a submission required under the 2016 Deeming Regulation. By November 8, 2019, vape (e-liquids and hardware), hookah…

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Redacting a FOIA Request

Redacting a FOIA Request – Tips & Insights The Freedom of Information Act Amendments of 1996 (FOIA). FOIA allows members of the public to request…

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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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FDA Due Dilligenc​e Review

FDA Due Diligence Review Congratulations, you sold or are planning to sell your company. Whether that’s a medical device, drug, food, dietary supplement or cosmetic…

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