Traditionally, the FDA’s collaboration with foreign authorities has meant a fairly predictable rate of US FDA inspections for foreign medical device manufacturers selling their products in the US. But with the Trump administration’s FDA exerting a new “America First” perspective, that may be changing. Mike Heyl, partner in the FDA Medical Device practice group at Hogan Lovells’ Washington, DC office, says that foreign device manufacturers should be aware of the growing rate of US FDA inspections at their facilities.
“While the number of overall inspections has fluctuated over the last five years, the one consistent upward trend has been the number of international inspections,” says Heyl, who sees multiple reasons for the FDA’s newly aggressive stance. “It’s not just protectionism in the United States — it’s also the number of operations occurring overseas and an increase in the number of manufacturers sending products into the US.”
The number of foreign device inspections has continued to grow despite recent efforts focused on improving inspection processes between US and foreign manufacturers. “Pilot programs like MDSAP (2014’s Medical Device Single Audit Program) were intended to create one inspection that would be good enough for all of the participating entities,” Heyl says. “Unfortunately, participation in that program has been small and we’re continuing to see a burden on manufacturers to meet multiple sets of regulations.”
With inspections on the rise, Heyl recommends that manufacturers start preparing long before the FDA arrives for a visit. “One thing we do (for clients) is go in and conduct an audit or an inspection as if we’re the FDA,” Heyl says. “We can train personnel at the company to be prepared for the inspection and to live through the types of questions the FDA will be asking.”
Heyl says that when inspection day arrives, being available to answer questions and provide documentation is crucial, and that simple professionalism during the visit will go a long way. “Don’t make things up, and if there is an answer to a question that you don’t know, then just say ‘Let me get back to you’,” he says. “You’re there to do your job, and the FDA is there to do its job, which is to ensure public health and safety.”
After a visit the FDA will issue what’s called a form FDA 483, which identifies what was uncovered during the inspection. The FDA gives companies 15 working days to respond before deciding whether to take additional action, and Heyl says it is essential that companies work with a deeply experienced legal team at this stage. “We can help a company draft a response and submit it to the FDA… help implement corrective actions… in many cases help companies implement their remediation plans, and put them into a language and format that the FDA will be able to understand.”
He says one of the most important things manufacturers can do to manage inspections is look for innovative ways to create a top-to-bottom culture of compliance. “I’ve seen successful companies put pictures up on their walls of patients who use their devices,” he says. “It instills a sense of responsibility at that company if you imagine your making this product for a friend or a loved one.”
Watch the video above for more exclusive insights from Mike Heyl on preparing for FDA inspections.
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