As medical technologies have become increasingly sophisticated and varied, US FDA has been confronted with the need for a more specialized inspectorate. Similarly, the increasingly globalized nature of medical device production has stretched FDA’s inspection resources, leading the agency to explore ways of working collaboratively with other regulators around the world. In turn, device-makers have had to grapple with FDA’s changing expectations, the potential for varying standards imposed by different regulators across the globe, and a lack of clarity as to FDA’s specific expectations for addressing inspection observations.
About The Authors
Nathan A. Brown (left) is a partner in Akin Gump's health care and life sciences practice who focuses on food and drug law. He formerly served as an...
FDA and Congress have recently taken significant steps to improve regulatory efficiency and predictability in the inspection of medical device facilities. Device-makers will need to adjust their practices to take...
