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.
Anesthesia
Biocompatibility
Cardiovascular
Dental/ENT
General
General Hospital/General Plastic Surgery
IVD
Materials
Nanotechnology
OB-GYN/Gastroenterology
Ophthalmic
Orthopedics
Physical Medicine
Radiology
Software/Informatics
Sterility
Tissue Engineering
The list is available at http://www.gpo.gov/fdsys/pkg/FR-2011-03-14/html/2011-5815.htm