FDA Releases Guidance to Industry Concerning Procedures for Requesting Information on Medical Device Classifications

On April 6, 2012, the Food and Drug Administration (FDA) released a guidance document for the medical device industry and FDA staff, addressing the procedures for submitting, reviewing and responding to requests submitted in accordance with section 513(g) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 360c(g).

Click the link below to read the full alert.