On March 14, 2011 the FDA issued Updated Recognition List #26. Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.
This new recognition list updates previous recognitions and identifies other standards recognized for the first time.
The announcement breaks the recognized standards into the categories listed below.
General Hospital/General Plastic Surgery
The list is available at http://www.gpo.gov/fdsys/pkg/FR-2011-03-14/html/2011-5815.htm