By Medilink member, Three Circles
A potential silver lining for medical device developers and manufacturers exists in the FDA’s response to 2016 “21st Century Cures Act”, with publication of a draft Guidance document outlining the agencies planned changes to the medical device approvals process and their oversight activities.
The 22 page document makes for heavy reading, so we’ve highlighted some of the key points that you should be aware of as you manufacture or develop medical devices for the US market. Many of the changes will have a positive impact upon your preparations for marketing authorisation submissions; 510(k), PMA, De Novo, IDE, etc.
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