You’ve Got Mail, and Twice the Time to Respond! Two Device Companies Find Themselves with 30 Business Days to Respond to FDA’s Warning Letters

No company wants to be on the receiving end of a Warning Letter, which is FDA’s primary tool for communicating to a company that it has been found to be in significant violation of regulatory requirements.  Typically, a company who receives a Warning Letter must submit a comprehensive response within 15 business days for the Agency to consider it to be timely.  This time period goes quickly, as the days are filled with investigations into FDA’s cited violations and corrective actions to address them, reports to management, consultations with outside experts, drafting and revising the response, and preparing and pulling together supporting evidence of the company’s actions.  All of this effort is intended to show FDA that the company understands the Agency’s concerns, that they are fully addressed, and that no further enforcement action is needed.  Under all that stress, companies often wish they had an extra day or two to respond.

A review of recently published Warning Letters reveals an interesting development; amidst a sea of 15-day response periods: the 30-business day response time.  On September 30 and October 7, FDA issued Warning Letters to FC Company and Dongguan Rainbow Tech alleging that the companies’ medical devices are adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) due to Quality System Regulation violations.  The underlying violations in the Warning Letter would not otherwise be blogworthy, but we find it notable that FDA offered these two companies 30 business days to respond to the Warning Letter.  In our firm’s decades of experience, the standard practice is for companies to have 15 business days to complete the activities necessary to submit an adequate original response to a Warning Letter.  Indeed, our experience is confirmed by our review of approximately 200 Warning Letters issued by FDA’s Center for Devices and Radiological Health (CDRH) over the past five years, which identified only the two instances identified above, issued just a week apart, in which FDA provided a 30-business day response period.

We recognize that the 15-business day response period is not a strict regulatory requirement. The Regulatory Procedures Manual (RPM) states:  “[a] request for correction and a written response within a specific period of time after the date of receipt of the letter, usually fifteen (15) working days.”  RPM, at 20 (emphasis added).   Accordingly, FDA is not acting contrary to its own procedures, but it is deviating from its standard protocol.

Also notable is that FDA is even more flexible with the response times it expects for Untitled Letters: “[t]he letter requests (rather than requires) a written response from the firm within a reasonable amount of time (e.g., “Please respond within 30 days”), unless more specific instructions are provided in a relevant Compliance Program.”  RPM, at 37.  Interestingly, a review of recently published Untitled Letters also reveals that FDA has often requested a 15-day response period, despite the more permissive framework.  See here, here, and here.

Is it a mistake?  On one hand, the RPM details a rigorous and structured process for Warning Letter submission and review.  On the other hand, like many government agencies, FDA has faced significant operational upheaval since January, including reductions-in-force (RIFs) and shifting internal expectations.  Many senior leaders and support staff in FDA’s inspection programs have departed over the past year, either by choice or as part of a RIF, with whispers (or shouts) of a draining morale.

Adding to this instability, FDA recently announced plans to merge all of its medical product and clinical research inspectorates – transitioning inspectors from specialized roles to generalized “medical product” inspectors – and to reverse a 2017 “program alignment” initiative that had ensured inspectors were experts in specific commodities.  While this so-called “Simple Reform” aims to enhance flexibility in deploying inspectional resources and to create surge capacity to meet fluctuating inspection demands, it has raised concerns among inspection experts about maintaining depth of knowledge and expertise.  Training inspectors to competently conduct a broader range of inspections, especially in technically complex areas, is resource-intensive and could risk diminishing inspection quality.

Finally, the federal government shutdown at the start of the new fiscal year may also have affected internal operations.  Although one of the two 30-business day Warning Letters was issued just before the shutdown (on September 30), FDA may have already been experiencing disruptions in the lead-up to the funding lapse.

We will keep an eye out for more response time variations.  In the meantime, we do not expect that the 30-business day response period will be routinely added to future Warning Letters.  At this point, they are still an anomaly!