Answer

 
 

No. If the biological specimens are used only for testing in a clinical laboratory or for basic scientific research and are not articles intended to prevent, treat, diagnos, or cure diseases, injuries, or conditions in humans, the specimens are not considered to be biological products subject to licensure by FDA in accordance with Section 351(a) [42 USC 262(a)] of the Public Health Service Act (PHS Act), nor would they appear to be a drug or device as defined in sections 201(g) and (h), respectively, of the Food, Drug, and Cosmetic Act, or an HCT/P as defined in 21 CFR 1271.3, which is promulgated under Section 361 of the PHS Act.



Last revised: March 28, 2007