Back in May of 2018, FDA held an open workshop regarding the Accreditation Scheme for Conformity Assessment (ASCA) which presented a path for expedited ISO 10993 biocompatibility and IEC 60601 Medical Electronic Equipment evaluation/testing reviews. A review of the background of the ASCA program and what’s coming in future will be coming from us at Biocompatibility Hub soon so stay tuned. At this workshop, the standards group at FDA noted that the number of consensus standards they recognized had gotten a bit out of hand and was becoming difficult to manage. In an effort to streamline the standards review process, and recognition thereof, FDA noted that they would be reducing the number of standards they would be recognizing. This would particularly apply to standards where there was redundancy between documents such as ANSI/AAMI (United States standards bodies) version of a 10993 standard and the actual ISO 10993 standard itself. If you’ve ever completed a Declaration of Conformance before, you know completing this and stating to the right standard could be tedious at times. In addition, ANSI/AAMI recognition of a standard has a more frequent review schedule than the actual standards themselves leading manufacturers to ask CROs to perform testing versions of a 10993 standard that didn’t actually exist. It was certainly confusing to manufacturers in some instances.
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Well, here we are in the middle of 2019 and FDA held true to their word and in July they launched an updated set of recognized standards which can be found here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm The list of overall recognized standards has been reduced either by consolidation or removal and the total list is much more manageable for most of the database. Where the two versions (ANSI/AAMI and ISO) would have individual recognition numbers, now they’re combined into a single recognition number. Here’s an example of the new format for ISO 10993-10:
This new format is sure to make lives easier when building submission files for FDA and we hope it helps make your life all the more less complicated. If you have any questions, you can reach out to us at Biocompatibility Hub at http://www.biocompatibilityhub.com/contact.html