Modifications to the initial list of recognized standards were announced on October 24, 2019, when the latest list of recognized standards “Recognition List Number: 052” was published in the Federal Register.
The latest list includes additions, withdrawals, corrections and revisions of certain consensus standards recognized by the FDA. Several areas have been impacted, such as: anesthesiology, biocompatibility, in vitro diagnostics (IVD), materials, nanotechnology, ophthalmic and orthopedic.
On September 14, 2018, FDA announced their guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices” describing how FDA has implemented its standards recognition program.
Among the most important new-entries in the list of recognized standards, we cite:
Dental/Ear, Nose and Throat (ENT):
- ISO 14801 (Third edition 2016-11-01) Dentistry—Implants—Dynamic loading test for endosseous dental implants;
- ISO 15142-1 (First edition 2003-08-01) Implants for surgery—Metal intramedullary nailing systems—Part 1-3;
- ISO 14242-4 (First edition 2018-05) Implants for surgery—Wear of total hip-joint prostheses—Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading;
- ISO 7206-10 (Second edition 2018-08) Implants for surgery—Partial and total hip-joint prostheses—Part 10: Determination of resistance to static load of modular femoral heads;
- ANSI/AAMI/UL 2800-1:2019 (American National Standard) Standard for Safety for Medical Device Interoperability.
Published on October 30, 2019.