510(k) statement

A 510(k) submitter includes either a 510(k) summary or a 510(k) statement. With the statement, the information is shared on request rather than published, but the commitment to respond still applies and has to be managed inside the company.

510(k) statement means a statement, made under section 513(i) of the act, asserting that all information in a premarket notification submission regarding safety and effectiveness will be made available within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information to be made available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret or confidential commercial information, as defined in § 20.61 of this chapter.

21 CFR, 807.3