FDA Approval
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…
Is the Premarket Tobacco Product Applications (PMTAs) stagnated?
Over the past few weeks, I continue to hear and receive questions regarding whether the Biden administration has frozen the PMTA process or rule. The short answer is no. The…
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…
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…
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…
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…
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…
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…
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…
The Microneedling Classification 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 Regulations (CFR)….