Business · 20/05/2010

FDA Releases Draft Guidance on Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program

The FDA is releasing a draft guidance document outlining the implementation of a provision of the Food and Drug Administration Amendments Act of 2007, which amends the Federal Food, Drug, and Cosmetic Act, and describes how the FDA's CDRH and CBER are implementing this provision.