Changing The Paradigm: 510(k) Draft Guidance May Raise New Questions
By
Jessica Bylander / Email the Author / “The Gray Sheet” Jan. 9, 2012, Vol. 38, No. 02
Regulatory / Word Count: 1953 / Article # 01120109020
Executive Summary
New concepts such as “primary predicates” and “reference devices” may be more confusing than clarifying, former FDA staffers say.
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