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510(k) Summary or Statement

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 been submitted, requests for copies of it are legally supposed to be furnished by FDA through the FOI process within 30 days after determining that the device is substantially equivalent to another device. A complete information about the essential components of a Summary can be found on FDA’s website.

510(k) Statements: If a 510(k) submitter chooses instead to provide a 510(k) statement, it must be on a separate letterhead page, clearly identified as "510(k) Statement," and signed by the certifier.
Written requests by any individual for a copy of the 510(k) must be fulfilled by the statement certifier within 30 days of receipt of the request. Only patient identifiers, trade secrets, and confidential commercial information may be purged from the statement. Those submitting 510(k) applications are not permitted to charge requesters for compiling and disseminating these data.

To read more about the 510(k) filing visit DeviceLink.

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