### §360e–3. Breakthrough devices

#### (a) Purpose

The purpose of this section is to encourage the Secretary, and provide the Secretary with sufficient authority, to apply efficient and flexible approaches to expedite the development of, and prioritize the Food and Drug Administration's review of, devices that represent breakthrough technologies.

#### (b) Establishment of program

The Secretary shall establish a program to expedite the development of, and provide for the priority review for, devices, as determined by the Secretary—

(1) that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions; and

(2)(A) that represent breakthrough technologies;

(B) for which no approved or cleared alternatives exist;

(C) that offer significant advantages over existing approved or cleared alternatives, including the potential, compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients' ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or

(D) the availability of which is in the best interest of patients.

#### (c) Request for designation

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.

#### (d) Designation process

#### (1) In general

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.

#### (2) 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.

#### (3) Withdrawal

The Secretary may not withdraw a designation granted under this section on the basis of the criteria under subsection (b) no longer applying because of the subsequent clearance or approval of another device that—

(A) was designated under this section; or

(B) was given priority review under section 360e(d)(5) of this title, as in effect prior to December 13, 2016.

#### (e) Expedited development and priority review

#### (1) Actions

For purposes of expediting the development and review of devices designated under subsection (d) the Secretary shall—

(A) assign a team of staff, including a team leader with appropriate subject matter expertise and experience, for each device for which a request is submitted under subsection (c);

(B) provide for oversight of the team by senior agency personnel to facilitate the efficient development of the device and the efficient review of any submission described in subsection (c) for the device;

(C) adopt an efficient process for timely dispute resolution;

(D) provide for interactive and timely communication with the sponsor of the device during the development program and review process;

(E) expedite the Secretary's review of manufacturing and quality systems compliance, as applicable;

(F) disclose to the sponsor, not less than 5 business days in advance, the topics of any consultation the Secretary intends to undertake with external experts or an advisory committee concerning the sponsor's device and provide the sponsor the opportunity to recommend such external experts;

(G) provide for advisory committee input, as the Secretary determines appropriate (including in response to the request of the sponsor) for applications submitted under section 360e(c) of this title; and

(H) assign staff to be available within a reasonable time to address questions by institutional review committees concerning the conditions and clinical testing requirements applicable to the investigational use of the device pursuant to an exemption under section 360j(g) of this title.

#### (2) Additional actions

In addition to the actions described in paragraph (1), for purposes of expediting the development and review of devices designated under subsection (d), the Secretary, in collaboration with the device sponsor, may, as appropriate—

(A) coordinate with the sponsor regarding early agreement on a data development plan;

(B) take steps to ensure that the design of clinical trials is as efficient and flexible as practicable, when scientifically appropriate;

(C) facilitate, when scientifically appropriate, expedited and efficient development and review of the device through utilization of timely postmarket data collection with regard to application for approval under section 360e(c) of this title; and

(D) agree in writing to clinical protocols that the Secretary will consider binding on the Secretary and the sponsor, subject to—

(i) changes to such protocols agreed to in writing by the sponsor and the Secretary; or

(ii) a decision, made by the director of the office responsible for reviewing the device submission, that a substantial scientific issue essential to determining the safety or effectiveness of such device exists, provided that such decision is in writing, and is made only after the Secretary provides to the device sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant are present and at which the director documents the substantial scientific issue.

#### (f) Priority review guidance

#### (1) Content

Not later than 1 year after December 13, 2016, the Secretary shall issue guidance on the implementation of this section. Such guidance shall—

(A) set forth the process by which a person may seek a designation under subsection (d);

(B) provide a template for requests under subsection (c);

(C) identify the criteria the Secretary will use in evaluating a request for designation under this section; and

(D) identify the criteria and processes the Secretary will use to assign a team of staff, including team leaders, to review devices designated for expedited development and priority review, including any training required for such personnel to ensure effective and efficient review.

#### (2) Process

Prior to finalizing the guidance under paragraph (1), the Secretary shall seek public comment on a draft version of that guidance.

#### (g) Rule of construction

Nothing in this section shall be construed to affect—

(1) the criteria and standards for evaluating an application pursuant to section 360e(c) of this title, a report and request for classification under section 360c(f)(2) of this title, or a report under section 360(k) of this title, including the recognition of valid scientific evidence as described in section 360c(a)(3)(B) of this title and consideration and application of the least burdensome means of evaluating device effectiveness or demonstrating substantial equivalence between devices with differing technological characteristics, as applicable;

(2) the authority of the Secretary with respect to clinical holds under section 360j(g)(8)(A) of this title;

(3) the authority of the Secretary to act on an application pursuant to section 360e(d) of this title before completion of an establishment inspection, as the Secretary determines appropriate; or

(4) the authority of the Secretary with respect to postmarket surveillance under sections 360i(h) and 360l of this title.

(June 25, 1938, ch. 675, §515B, formerly §515C, as added Pub. L. 114–255, div. A, title III, §3051(a), Dec. 13, 2016, 130 Stat. 1121; renumbered §515B and amended Pub. L. 115–52, title IX, §901(f), (g), Aug. 18, 2017, 131 Stat. 1076, 1077.)

#### **Editorial Notes**

#### Amendments

2017—Pub. L. 115–52, §901(f)(1), made technical amendment to directory language of Pub. L. 114–255, §3051(a), which added this section.

Subsec. (f)(2). Pub. L. 115–52, §901(g), substituted "a draft version of that guidance" for "a proposed guidance".

#### **Statutory Notes and Related Subsidiaries**

#### Effective Date of 2017 Amendment

Pub. L. 115–52, title IX, §901(f), Aug. 18, 2017, 131 Stat. 1076, provided that the renumbering and amendment made by section 901(f) is effective as of the enactment of Pub. L. 114–255.