The FDA released two final guidances and a new draft guidance today to increase the regulatory clarity around medical devices, including software as a medical device. The agency also announced the ...
The FDA has extended the comment period on it “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” document until Nov. 28, according to a Mass Device ...
A new FDA draft guidance specifies what kinds of changes in existing medical devices would require new 510(k) submissions, according to an FDA release. For example, changes in device features, such as ...
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