21 U.S.C. § 360m — Accredited persons

(a) In general (1) Review and classification of devices By one year after November 21, 1997, the FDA had to start accrediting outside people or organizations to review reports device makers submit under section 360(k) and to recommend how new devices should be classified under section 360c(f)(1). (2) Requirements regarding review (A) When an accredited reviewer recommends a classification, it must tell the FDA in writing why. (B) The FDA then has 30 days after getting that recommendation to decide the device's classification. (C) The FDA can change the classification the reviewer recommended; if it does, it must give both the reviewer and the device maker a detailed written explanation why. (3) Certain devices (A) An accredited reviewer cannot review: (i) a class III device; (ii) certain devices classified or designated under specific other sections; (iii) a device meant to be permanently implanted or to sustain or support life — unless the FDA has specifically determined and listed that device type as eligible; or (iv) any device type the FDA has listed as not eligible. (B) To decide which device types are eligible, the FDA must: (i) issue draft guidance explaining the factors it will use — including the device's risk level, whether it's permanently implanted or life-sustaining/supporting, and whether there's a strong public-health reason to allow accredited review; (ii) finalize that guidance within 24 months after issuing the draft; and (iii) once finalized, publish and keep updated, on the FDA's website, a list of class I and class II device types and whether each is eligible for accredited-reviewer review. (C) Until the FDA posts that updated list, the list in effect on August 18, 2017 stays in effect. (b) Accreditation (1) Programs The FDA can run its accreditation program itself, through other government agencies, or through qualified private organizations. (2) Accreditation (A) Within 180 days after November 21, 1997, the FDA had to publish criteria in the Federal Register for granting or denying accreditation, respond to requests within 60 days, and specify exactly which review activities each accredited person is approved for. (B) The FDA can suspend or withdraw someone's accreditation — after notice and an informal hearing — if that person seriously fails to follow the rules, threatens public health, or acts against the purpose of this section. (C) To make sure accredited reviewers keep meeting standards, the FDA must make periodic on-site visits to audit them, plus take any other steps it thinks appropriate. (D) (i) Accreditation lasts 3 years, unless suspended or withdrawn early. (ii) The FDA must approve or deny a reaccreditation request within 60 days. (iii) Within 120 days after July 9, 2012, the FDA had to publish reaccreditation criteria, specifying which activities and devices each reaccredited person covers. (3) Qualifications To be accredited, a person or organization must: (A) not be a federal employee; (B) be independent — not owned, controlled by, or financially tied to a device maker, supplier, or vendor; (C) be a legally valid entity allowed to do this work; (D) not design, make, promote, or sell devices; (E) follow standard professional and ethical business practices; and (F) commit — when applying and while reviewing — to: (i) certify that what it reports matches the data it reviewed; (ii) only take on work it's actually competent and able to handle; (iii) keep the information, records, and recommendations it receives confidential; (iv) promptly try to resolve complaints about its work; and (v) keep any employee with a financial conflict of interest off a review of that device, and publish yearly disclosures about its compliance with this conflict-of-interest rule. (4) Selection of accredited persons For anyone wanting an accredited reviewer for a section 360(k) report, the FDA must offer a panel of at least two accredited reviewers to choose from. (5) Compensation of accredited persons Whoever hires the accredited reviewer pays for it, at a price the two of them agree on. (c) Duration This accreditation program ends on October 1, 2027.