27 Jul '16, 4pm

by @eetimes

WASHINGTON—Medical device developers preparing pre-market submissions to the Food and Drug Administration (FDA) can refer to new and updated guidance. Published by FDA in mid-June, the recommendations help determine if an adverse biological effect is likely when a medical device comes into direct or indirect contact with the human body through patient tissues or a clinical practitioner. Many new items appear in this broad scope of recommendations (International Organization for Standardization (ISO) 10993-1 standard ), which build on the 1995 ISO standard and its 2009 revision. As a first step, FDA advises applicants to use a risk management process when conducting their biological evaluation of a proposed medical device or component. This approach may eliminate unneeded biocompatibility testing and animal testing. Other recommendations include suggestions for chemical ass...

Full article: http://www.eetimes.com/document.asp?doc_id=1330200

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