The Federal Food, Drug, and Cosmetic Act 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. FDA announced Recognition List Number 23 with the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the agency’s searchable database.
The announcement is at http://edocket.access.gpo.gov/2010/2010-10562.htm
The list modifies standards in the following areas: Biocompatibility, Cardiology, Dental/ENT, General, In Vitro Diagnostics, Materials, Physical Medicine, Sterility, and Tissue Engineering.
The list recognizes new standards in the following areas: Cardiology, In Vitro Diagnostics, Orthopedics, Physical Medicine, and Sterility.
An area of interest is the ISO 10993 family of standards on Biological Evaluation of Medical Devices. The table below shows the changes to this recognition status of this family.
| Standard | Change |
|---|---|
| ANSI/ AAMI/ ISO 10993-1:2003 Biological Evaluation of Medical Devices–Part 1: Evaluation and Testing | Title, Extent of recognition, and Relevant guidance |
| ANSI/AAMI/ISO 10993-3:2003 Biological Evaluation of Medical Devices–Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity | Title, Extent of recognition, and contact person |
| ANSI/AAMI/ISO 10993-5:2009 Biological Evaluation of Medical Devices–Part 5: Tests for in vitro Cytotoxicity | Withdrawn and replaced with newer version |
| ANSI/AAMI/ISO 10993-6:2007 Biological Evaluation of Medical Devices–Part 6: Tests for Local Effects after Implantation | Title and Extent of recognition |
| ISO 10993-10:2002 Biological Evaluation of Medical Devices–Part 10: Tests for Irritation and Delayed-Type Hypersensitivity | Extent of recognition, and Relevant guidance |
| ISO 10993-10:2002/Amd.1:2006(E) Evaluation of Medical Devices–Part 10: Tests for Irritation and Delayed-Type Hypersensitivity AMENDMENT 1 | Extent of recognition, and Relevant guidance |
| ANSI/AAMI/ISO 10993-11:2006 Biological Evaluation of Medical Devices–Part 11: Tests for Systemic Toxicity | Title, Extent of recognition, and Relevant guidance |
| ANSI/ AAMI/ ISO 10993-12:2007 Biological Evaluation of Medical Devices–Part 12: Sample Preparation and Reference Materials | Title, Extent of recognition, and Relevant guidance |