BayBiotech.NET A premarket notification from a manufacturer must include either a summary of the 510(k) safety and effectiveness information of the product upon which the substantial-equivalence determination is based or a statement that this information will be made available by the 510(k) applicant to any person within 30 days of a written request. As per FDA definition, these are the definition of Summary and Statements: Summaries are released by FDA regarding a 510(k) clearance when requested under the Freedom of Information (FOI) Act whereas Statements are used to arrange for this FOI request to be fulfilled by the 510(k) applicant. 510(k) Summaries: If a summary is included, it must be submitted with the 510(k) notification as per FDA guidelines. The summary must be complete and correct in order for FDA to complete its review of a 510(k) submission. FDA will accept summaries and amendments until it issues a determination of substantial equivalence. If a summary has be...
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