FDA Corrects Errors in Dura Mater/Allografts Notice
02/04/2004
Federal Register Interim final rule: FDA is correcting small errors in an interim final rule that published in the 1/27 Federal Register, which excepted human dura mater and human heart valve allografts, currently subject to application or notification requirements under the Federal Food, Drug, and Cosmetic Act from the scope of the definition of “human cells, tissues, or cellular or tissue-based products (HCT/P's)” subject to the registration and listing requirements contained in 21 CFR Part 1271. To view this interim final rule, click here.
