21 U.S.C. § 360e–3 — Breakthrough devices

(a) Purpose This section exists to encourage the Secretary, and give the Secretary the authority, to use efficient and flexible approaches that speed up the development of, and prioritize FDA review of, devices that represent breakthrough technologies. (b) Establishment of program The Secretary must set up a program to speed up development and give priority review to devices, as the Secretary determines, that (1) provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, and (2) either represent breakthrough technology, have no approved or cleared alternative, offer major advantages over existing approved alternatives (such as avoiding hospitalization, improving quality of life, helping patients manage their own care, or creating long-term clinical efficiencies), or are otherwise in patients' best interest, as the Secretary decides. (c) Request for designation A device's sponsor may ask the Secretary to designate it for this expedited path at any time before submitting a premarket approval application, a premarket notification, or a classification petition. (d) Designation process The Secretary has 60 calendar days after receiving a request to decide whether the device meets the criteria in subsection (b); if it does, the Secretary must designate it for expedited development and priority review. A team of experienced FDA staff and senior managers reviews each request. Once a device is designated, the Secretary cannot withdraw that designation just because a different device — whether designated under this section or given priority review under the older version of section 360e(d)(5) — is later cleared or approved. (e) Expedited development and priority review For every designated device, the Secretary must: assign a dedicated staff team, led by someone with relevant expertise; have senior agency staff oversee that team; use an efficient process to resolve disputes quickly; communicate with the sponsor regularly throughout development and review; speed up review of manufacturing and quality-system compliance; tell the sponsor, at least 5 business days in advance, what topics the Secretary plans to raise with outside experts or an advisory committee, and let the sponsor suggest experts; provide advisory committee input as appropriate, including at the sponsor's request; and make staff available to answer institutional review board questions about the device's investigational testing conditions. Working with the sponsor, the Secretary may also, as appropriate: agree early on a plan for developing the needed data; make clinical trial designs as efficient and flexible as scientifically appropriate; use timely postmarket data collection to support the approval application, when scientifically appropriate; and agree in writing to clinical trial protocols that bind both the Secretary and the sponsor — changeable only if both agree in writing, or if the review office's director decides, in writing and only after giving the sponsor a chance to meet and be heard, that a substantial scientific issue affecting the device's safety or effectiveness has arisen. (f) Priority review guidance Within 1 year of December 13, 2016, the Secretary had to issue guidance on how this section works: the process for requesting designation, a request template, the criteria used to evaluate requests, and the criteria and process (including training) for assigning review teams and team leaders. The Secretary had to seek public comment on a draft of that guidance first. (g) Rule of construction Nothing in this section changes: the standards used to evaluate a premarket approval application, a classification report, or a premarket notification — including how valid scientific evidence is recognized and how the "least burdensome" approach to proving effectiveness or substantial equivalence is applied; the Secretary's authority over clinical holds; the Secretary's authority to act on an approval application before an establishment inspection is finished, as appropriate; or the Secretary's authority over postmarket surveillance.