In late October 2019, the U.S. Food and Drug Administration (FDA) published more than 80 additions, withdrawals or modifications to its list of recognized consensus standards for medical devices sold on the U.S. market. The recognized consensus standards are used by the FDA in the pre-market approval process to measure device safety and effectiveness.
Under this process, manufacturers may submit a declaration of conformity with a recognized consensus standard in place of test data and reports demonstrating conformity with a standard.
The recent update covers a wide range of categories. Modification to existing standards include anesthesiology equipment, biocompatibility of devices, safety and performance standards for cardiovascular stents and non-invasive automated sphygmomanometers, equipment connectors, intraocular lenses, pieces for needles and thermometers, standards for lab diagnostics and radiology tests, orthopedic implant testing standards, sterility standards for medical equipment and supplies, and tissue engineering guidelines.
New standard additions include anesthesiology equipment, biocompatibility of devices, endosseous dental implant testing, standby battery standards, safety and performance standards for microwave therapy equipment, lab diagnostic standards, standards for electron spin resonance used to measure reactive oxygen species from metal oxide nanoparticles, lens and microscope standards, orthopedic implant testing standards, standards for nails used to secure implants to bones, wheelchair test standards to accommodate for changes to occupant posture, and new medical software standards.
Established as part of the FDA Modernization Act of 1997, the Recognized Consensus Standards database is a collection of FDA-recognized voluntary standards used to help facilitate the premarket approval process for medical devices.
The FDA updates this database a few times a year and all updates can be found at this link.
By Benjamin Duong
Benjamin Duong is a medical student and freelance writer based in Dothan, Alabama. He has a Masters of Public Health from the George Washington University and majored in microbiology and political science at the University of Florida. He has worked on advocacy for issues ranging from medical education to global maternal and infant mortality.