21 U.S. Code § 360e–3 - Breakthrough devices
A sponsor of a device may request that the Secretary designate such device for expedited development and priority review under this section. Any such request for designation may be made at any time prior to the submission of an application under section 360e(c) of this title, a notification under section 360(k) of this title, or a petition for classification under section 360c(f)(2) of this title.
Not later than 60 calendar days after the receipt of a request under subsection (c), the Secretary shall determine whether the device that is the subject of the request meets the criteria described in subsection (b). If the Secretary determines that the device meets the criteria, the Secretary shall designate the device for expedited development and priority review.
Review of a request under subsection (c) shall be undertaken by a team that is composed of experienced staff and senior managers of the Food and Drug Administration.
Prior to finalizing the guidance under paragraph (1), the Secretary shall seek public comment on a draft version of that guidance.
Subsec. (f)(2). Pub. L. 115–52, § 901(g), substituted “a draft version of that guidance” for “a proposed guidance”.
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