Posts by Marc Sanchez
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 be wrong. Typically, we talk about FDA Warning Letters, which is a precursor to formal enforcement actions by the Agency. An FDA IHCTOA Letter, however, is a private letter (i.e.,…
Read MoreMicroneedling 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) filed following the formal issuance of the Microneedling Classification Order this summer (link to Classification Order here). The FDA Atty firm worked with Esthetic Education LLC to file a microneedling 510(k) for…
Read More510(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 example, a particularly important process to follow. The FDA published a draft guidance entitled “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers” in December 2014 (See, Docket No. FDA-2014-D-1837). The draft…
Read MoreCoronavirus 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 submission requests. Many questions are about how to import medical devices and drugs, in particular, and 95 masks and hand sanitizers. It is important to remember that the FDA continues…
Read MoreFDA 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 law. FDA guidance documents are not a source of law but an interpretation of existing law (1). Also, the Guidance Document makesclear that the FDA through this flavor ban is…
Read MoreFDA 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 what’s been released so far. “FDA intends to finalize a compliance policy in the coming weeks that would prioritize the agency’s enforcement of the premarket authorization requirements for non-tobacco-flavored e-cigarettes, including mint and…
Read MoreOut 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FDA to deactivate out-of-date drug listings in its database The US Food and Drug Administration (FDA) has announced that it will deactivate out of date drug listings in its database including any that have not been recently updated or are inaccurate, as required by regulation, or that include an establishment with an expired registration. “FDA…
Read MoreFDA 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 and Cosmetic Act (FDC&A). The FDA can issue a seizure or an injunction but both require a court order, which can take time to obtain. Many states, like California, allow…
Read More510(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 FDA review time tells only half the story. There are many factors that can impact the timing to complete the 510(k) process. Preparing and Pre-Submissions Naturally, before the 90-day statutory…
Read MorePlasma 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?” Based on a search of the De Novo, PMA, and 510(k) databases at the time of this post, no entry could be found for plasma microneedling. That means any plasma…
Read MoreHPHC
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 and cigar companies (manufacturers, importers or agents) will need to file an HPHC. There’s been confusion about what an HPHC submission involves. In particular, since the last FDA Guidance was…
Read MoreRedacting 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 copies of records not normally prepared for public distribution. This includes regulatory submissions (e.g., NDAs, 510(k)s, PMTA, etc.) and enforcement materials and correspondence (e.g., Warning Letter responses, Form 483s, It…
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