Combination Product Makers Are Asked to Comment

Manufacturers of combination products have their second chance in three years to comment to the FDA about the range of information the agency requires to determine which division will take primary responsibility for reviewing premarket applications. In a notice published last week in the Federal Register, the agency seeks comments on the request for designation process created under 21 CFR Part 3 in 2003. The agency is asking stakeholders to comment by Oct. 24 on whether the information collection is necessary.
Devices and Diagnostics Letter