Federal court limits FDA discretion in “drug” vs. “device” classification
By EsqSocial Corporation 21/05/21
The U.S. Court of Appeals for the D.C. Circuit recently decided in Genus Medical Technologies LLC v. U.S. Food and Drug Administration that, when classifying a biomedical product as either a “drug” or a “device,” FDA does not have unfettered discretion to regulate that product as a drug, even if the product could reasonably meet…...
By: Hogan Lovells