A premarket notification must include either a summary of the 510(k) safety and effectiveness information 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.129,130 In order to comply with this requirement, manufacturers should familiarize themselves with FDA’s exact definition of the terms summary and statement.131,132
Summaries are released by FDA when requested under the Freedom of Information (FOI) Act; statements are used to arrange for this FOI request to be fulfilled by the 510(k) applicant. The decision whether to include a summary or a statement can be changed any time before the substantial equivalence determination is reached, but not after.
510(k) Summaries. If a summary is included, it must be submitted with the 510(k) notification and clearly marked as such in order for FDA to begin its review. There are specific dos and don’ts in putting together a summary. One absolute is that this summary must be complete and correct in order for FDA to complete its review of a 510(k) submission. The FDA will accept summaries and amendments until it issues a determination of substantial equivalence.133 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.
510(k) Statements. If a 510(k) submitter chooses instead to provide a 510(k) statement to satisfy the aforementioned conditions, that statement must be submitted with the notification in order for the FDA to begin its review. The statement should be on a separate letterhead, clearly identified as “510(k) Statement” and signed by the certifier, and it must include specific words beginning with “I certify… .”134 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 user identifiers, trade secrets, and confidential commercial information may be purged from the statement. The FDA publishes the names of certifiers on the monthly list of premarket notification submissions for which substantial-equivalence determinations have been made.135 Those submitting 510(k) applications are not permitted to charge requesters for compiling and disseminating these data.
If a 510(k) submitter fails to comply with the commitment made in the 510(k) statement, the FDA will provide the public with a purged copy of the 510(k) submission.
Noncompliance with the 510(k) statement is a prohibited act; The FDA will use its enforcement powers to obtain compliance.