“Medical Device Warning Letters Under the First Nine Months of the Trump Administration” by Evan Phelps

Savvy medical device manufacturers understand that reviewing FDA Warning Letters offers strategic, operational, and compliance benefits. For example, such information can reveal patterns regarding FDA’s evolving priorities and enforcement focus areas, which, in turn, can enable device firms to create focused, data-driven risk mitigation plans. Publicly available records indicate that at least 34 medical device-related Warning Letters have been issued since the Trump administration took office. From these, we can draw the following preliminary conclusions.

Continued Focus on QSR Compliance

Approximately 86% of the Warning Letters issued during this period focused on QSR compliance issues with the top five observations being:

• Corrective and Preventive Action (CAPA) – cited in 26 Warning Letters;
• Design Controls – cited in 25 letters (including failures to evaluate design changes requiring new 510(k) submissions);
• Complaint Files – cited in 23 letters (inadequate complaint investigation and trending);
• Purchasing Controls – cited in 15 letters; and
• Process Validation – cited in 14 letters.

This top five list can be used by firms for internal audit prioritization purposes to better prepare for any potential FDA inspection under the current administration.

Scrutiny of Device Modifications

In addition, our review indicates that FDA is maintaining an aggressive posture on device modifications. Pursuant to 21 C.F.R. § 807.81, 510(k) cleared devices currently in distribution that have been “significantly” changed or modified in design, components, method of manufacture, or intended use require a new 510(k) submission and clearance for the lawful distribution of the modified device. Significant changes include any technological changes that could affect the device’s safety or effectiveness and/or any changes or modifications to the device’s intended use.

At least 32% of the Warning Letters issued during this period cited violations related to device changes made without the required 510(k) clearance. Six of these letters involved technological changes wherein design changes may not have been properly evaluated by the manufacturer pursuant to FDA’s guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which provides FDA’s interpretation of the changes it believes could significantly affect the safety or effectiveness of a device. Ensuring that responsible employees are aware of this guidance and properly trained in its application would, thus, appear to be a timely risk mitigation strategy for companies considering such changes.

FDA Independently Reviewing Firm Websites and Promotional Materials

It appears that FDA is increasing its efforts to proactively review device firms’ websites and other promotional materials to identify changes to intended use that would necessitate a new 510(k) clearance for the subject device.  Seven of the Warning Letters regarding objectionable changes made to an existing device referenced changes that were made to the device’s intended use. The number of Warning Letters that include this type of observation suggests the agency is increasing surveillance and scrutiny of promotional materials.

This proposition is supported by our own experience over the past few months, during which we have noticed an uptick in FDA’s issuance of “It Has Come to Our Attention” (IHCTOA) letters. These letters are not publicly available and are typically issued when FDA believes the company may be inappropriately promoting a device, but the facts do not yet warrant a Warning Letter. Notably, the IHCTOA letters we provided assistance with each directly quoted statements found on the target company’s website and other marketing materials. When combined with the Warning Letter evidence, this strongly suggests to us that the FDA is placing an emphasis on identifying and addressing these types of promotional issues.

Accordingly, it would be advisable to review promotional and other marketing materials to identify and mitigate any potential regulatory risks prior to publication and public dissemination.

About the Author

Evan has been assisting the medical device industry with US FDA regulatory assistance for over 20 years, has been consistently recognized in The Best Lawyers in America for FDA law since 2020, and has previously taught FDA law to FDA officials for the CDRH Staff College and at to students at the George Mason University School of Law.