FDA Approval

FDA Plans to Launch Updated Submission Portal for New Tobacco Product Applications in 2025

The FDA’s Center for Tobacco Products (CTP) has announced its plans to unveil the CTP Portal Next Generation (“CTP Portal NG”) in 2025, an improved…

Read More

Supreme Court Agrees to Hear Case Challenging FDA’s Vape Regulation

Supreme Court Grants FDA’s Petition for Certiorari in Wages and White Lion Investments v. Food & Drug Administration In a significant move that could reshape…

Read More

Triton Files Brief in Opposition to FDA’s Supreme Court Petition to Review PMTA Reversal

As previously posted, a federal appeals court (Fifth Circuit Court of Appeals) overturned the Marketing Denial Orders (MDOs) handed down by the U.S. Food and…

Read More

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…

Read More

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…

Read More

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….

Read More

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…

Read More

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)…

Read More

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 following a sale, for…

Read More

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…

Read More

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 90-days of…

Read More

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 is no single…

Read More