FDA Drug to Device Transition: 4 Things You Need to Know

The U.S. Food and Drug Administration's plans to transition certain products regulated as drugs to device status are causing concern in the pharmaceutical sector. What is happening, and what can you do if your product is impacted? Andrew Papas, Vice President of Pharmaceutical Services Regulatory Affairs at NSF, looks at this issue.

• Why is the FDA transitioning drug products to medical device status?
• What products have been impacted by the FDA's decision to transition products?
• How has the pharmaceutical industry reacted to the FDA's decision to transition products?
• What should you do if the decision impacts your company?

In August 2021, the agency announced in a Federal Register notice that it would be publishing a list of drug products that it determined should be reclassified as medical devices. The decision was made based on a legal case in the U.S. Court of Appeals, DC Circuit Court of Genus Medical Technologies LLC v. the FDA.

The case centered on a ruling that the FDA does not have the sweeping discretion to classify a product (barium sulfate, in this case) that meets both the definition of a drug and a device automatically as a drug. The agency's preference to classify borderline products as drugs has brought about this change.

In August 2021, the agency announced in a Federal Register notice that it would be publishing a list of drug products that it determined should be reclassified as medical devices. The decision was made based on a legal case in the U.S. Court of Appeals, DC Circuit Court of Genus Medical Technologies LLC v. the FDA.

The case centered on a ruling that the FDA does not have the sweeping discretion to classify a product (barium sulfate, in this case) that meets both the definition of a drug and a device automatically as a drug. The agency's preference to classify borderline products as drugs has brought about this change.