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fda 510k premarket notification

How to Determine Substantial Equivalence for an FDA 510k

fda 510k substantial equivalence
An FDA 510(k) Premarket Notification is a document containing information required under 21 CFR 807 Subpart. It is based on the concept of substantial equivalence (SE) to a medical device legally marketed in the USA (or predicate device). An FDA 510(k) Premarket Notification...
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