Blog

Read the blog for important updates to FDA and USDA rules and regulations that could affect your business.

All
  • All
  • FDA Approval
  • FDA Enforcement
  • FDA News Update
  • FDA Q&A

FDA IHCTOA Letter

What does IHCTOA mean? FDA IHCTOA Letter is an acronym for It Has Come to Our Attention Letter, which is an early alert something may…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

Out of Date Drug Listings

FDA to deactivate out-of-date drug listings in its database The US Food and Drug Administration (FDA) has announced that it will deactivate out of date…

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

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…

Read More

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?”…

Read More

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…

Read More

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…

Read More