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., not published on FDA’s website but remain subject to disclosure pursuant to FOIA request) that provides a critical opportunity to avoid an FDA Warning Letter.

30-Days

Most FDA IHCTOA Letters provide 30-days to respond. This is more than the 15-days provided to respond to a Warning Letter or Form 483 or the 7-days required to respond to a Notice of Action when importing. It’s important not to rush a response and use the time wisely by reviewing claims, confirming registrations or classifications, and verifying what the regulations permit.

CDRH

In certain situations, CDRH may become aware a company may be promoting a medical device product in a way that potentially violates the Federal Food, Drug, and Cosmetic Act. CDRH issues an IHCTOA Letter to the company as an early communication to gather additional information and provide the company to respond with evidence of compliance or corrective actions.

CTP

In 2019 FDA CTP used the IHCTOA Letter to verify compliance with the Deeming Regulation. In particular, FDA sought evidence of when a tobacco product entered the market. The FDA took the extra step of publishing these letters, such as this example.

IHCTOA Response Tips

When responding to FDA it’s important to read the letter carefully and respond in a timely and professional manner. Be sure to clearly understand what FDA is asking for and respond with the specific information needed. Don’t be afraid to take responsibility, such as acknowledging claims that were problematic and providing proof of revisions. And always, if in doubt consult with an expert.