FDA PRIA Reference SBA Size Standards Update

The FDA has updated its PRIA Reference document to reflect current Small Business Administration (SBA) size standards. This update is primarily informational, providing revised benchmarks for classifying businesses as small entities for the purposes of the PRIA process. The document is available for download from regulations.gov.

While this update does not introduce new compliance obligations, regulated entities, particularly drug and medical device manufacturers, should be aware of the revised size standards. These standards may affect how their business is classified for certain FDA regulatory submissions and processes. Compliance officers should ensure they are referencing the most current SBA size standards when interacting with the FDA's PRIA process.