FDA Approval

eSTAR Medical Device Submissions

The eSTAR (Electronic Submission Template and Resource) is an interactive PDF form designed to assist applicants in preparing comprehensive medical device submissions. It offers various…

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Why was created the Remote Regulatory Assessments (RRA)?

Remote Regulatory Assessments A Remote Regulatory Assessment is a necessity created by the COVID-19 pandemic. Ordinarily, FDA would conduct an on-site audit as part of…

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Is the Premarket Tobacco Product Applications (PMTAs) stagnated?

Over the past few weeks, I have continued to hear and receive questions regarding whether the Biden administration has frozen the PMTA process or rule. The short answer is no….

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Premarket Tobacco Product Applications (PMTAs) Tips

PMTA Tips There are a few tips in preparing a Pre-Market Tobacco Application (PMTA). Since September 9, 2020, the PMTAs deadline for e-cigarettes (also known…

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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 first microneedling 510(k)…

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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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