Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg BNA Medical Devices Law & Industry Report, in “Medical Device Decision Guidance Revised in Response to Criticism,” by Dana A. Elfin.
Following is an excerpt:
But the agency could stand to improve its guidance for how the FDA and industry should make decisions regarding product recalls, Thompson said, even if this particular guidance isn’t the appropriate place to do it.
“This guidance provides very little regulatory insight into the proper process for making a recall decision of any sort, whether removal or correction,” he said. “I understand that may be outside the scope of this document, but it is a topic sorely lacking in FDA guidance. And it inhibits the effectiveness of this document because that regulatory analysis has to proceed this scientific analysis.”
“One of the big gaps in FDA guidance I believe is a clear explanation for how FDA and industry should make decisions regarding recalls,” he said.
“The regulations cryptically direct FDA and industry to consider whether there has been a material violation of the law,” Thompson said. “In practice, industry and FDA need to make decisions around risk.”