Standards
This article was originally published in RAJ Devices
Executive Summary
US FDA updates list of recognised standards
US FDA updates list of recognised standards
The US Food and Drug Administration has updated the list of standards it recognises for use in premarket reviews for medical devices1. The publication that contains the changes to the list also establishes a new internal numbering system that is designed to facilitate the use of Form 3654 (Standards Data Report for 510(k)s), which must accompany premarket notifications and serves to standardise certification of conformance with a recognised standard.
The publication, entitled Modifications to the List of Recognized Standards, Recognition List Number: 020, includes 32 newly added standards, including nine from the International Standards Organization concerning dental devices and cardiovascular implants, and nine from the Clinical and Laboratory Standards Institute for in vitrodiagnostics. Other new standards relate to biocompatibility, sphygmomanometers, materials used in devices, ob-gyn/gastroenterology, ophthalmology, physical medicine (relating to platform lifts and chairlifts) and sterility. Many of the other changes to the list relate to standards that have been withdrawn and replaced with a newer version.
The FDA will incorporate these changes into the list of FDA Recognised Consensus Standards in the searchable database on the agency's website at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm. These modifications to the list of recognised standards were effective from 9 September.
The FDA Modernization Act of 1997 (FDAMA) allows the FDA to recognise consensus standards developed by international and national organisations for satisfying portions of device premarket review submissions. Anyone may recommend consensus standards as candidates for recognition by the FDA under the FDAMA. In order to be considered, recommendations should contain the following: the title of the standard; any reference number and date; the name and address of the standards development organisation; a proposed list of devices for which a declaration of conformity to the standard should routinely apply; and a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity.
References
1. Federal Register, 9 September 2008, 73(175), 52358-52385, http://edocket.access.gpo.gov/2008/pdf/E8-20939.pdf