A bill to allow for devices with a predetermined change control plan to be marketed  without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.
Bill: S.4386 | Sponsor: Sen. Braun, Mike (R-IN)
Policy area: Health

Summary:
This bill allows changes to be made to medical devices without the need for supplemental applications or premarket notifications if the changes are made in accordance with a predetermined change control plan.

To allow for devices with a predetermined change control plan to be 
  marketed without submitting a supplemental application or premarket 
 notification if the changes to such devices are consistent with such 
                                 plan.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. PREDETERMINED CHANGE CONTROL PLANS FOR DEVICES.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 515B 
(21 U.S.C. 360e-3) the following:

``SEC. 515C. PREDETERMINED CHANGE CONTROL PLANS FOR DEVICES.

    ``(a) Approved Devices.--
            ``(1) In general.--Notwithstanding section 515(d)(5)(A), a 
        supplemental application shall not be required for a change to 
        a device approved under section 515, if such change is 
        consistent with a predetermined change control plan that is 
        approved pursuant to paragraph (2).
            ``(2) Predetermined change control plan.--The Secretary may 
        approve a predetermined change control plan submitted in an 
        application, including a supplemental application, under 
        section 515 that describes planned changes that may be made to 
        the device (and that would otherwise require a supplemental 
        application under section 515), if the device remains safe and 
        effective without any change.
            ``(3) Scope.--The Secretary may require that a change 
        control plan include labeling required for safe and effective 
        use of the device as such device changes pursuant to such plan, 
        notification requirements if the device does not function as 
        intended pursuant to such plan, and performance requirements 
        for changes made under the plan.
    ``(b) Cleared Devices.--
            ``(1) In general.--Notwithstanding section 510(k), a 
        premarket notification shall not be required for a change to a 
        device cleared under section 510(k), if such change is 
        consistent with an established predetermined change control 
        plan granted pursuant to paragraph (2).
            ``(2) Predetermined change control plan.--The Secretary may 
        clear a predetermined change control plan submitted in a 
        notification submitted under section 510(k) that describes 
        planned changes that may be made to the device (and that would 
        otherwise require a new notification), if--
                    ``(A) the device remains safe and effective without 
                any such change; and
                    ``(B) the device would remain substantially 
                equivalent to the predicate.
            ``(3) Scope.--The Secretary may require that a change 
        control plan include labeling required for safe and effective 
        use of the device as such device changes pursuant to such plan, 
        notification requirements if the device does not function as 
        intended pursuant to such plan, and performance requirements 
        for changes made under the plan.
    ``(c) Predicate Devices.--In making a determination of substantial 
equivalence pursuant to section 513(i), the Secretary shall not compare 
a device to changed versions of a device implemented in accordance with 
an established predetermined change control plan as a predicate device. 
Only the version of the device cleared or approved, prior to changes 
made under the predetermined change control plan, may be used by a 
sponsor as a predicate device.''.
    (b) Conforming Amendments.--
            (1) Cleared devices.--Section 510(l)(1) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)(1)) is amended, 
        in the first sentence, by inserting ``, or with respect to a 
        change that is consistent with a predetermined change control 
        plan cleared under section 515C'' before the period at the end.
            (2) Approved devices.--Section 515(d)(5)(A)(i) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        360e(d)(5)(A)(i)) is amended by striking ``A supplemental'' and 
        inserting ``Unless the change is consistent with a 
        predetermined change control plan approved under section 515C, 
        a supplemental''.
            (3) Documentation of rationale for significant decisions.--
        Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 360g-1(a)(1)) is amended to read as follows:
            ``(1) In general.--The Secretary shall provide a 
        substantive summary of the scientific and regulatory rationale 
        for any significant decision of the Center for Devices and 
        Radiological Health regarding submission or review of a report 
        under section 510(k), a petition for classification under 
        section 513(f), an application under section 515, or an 
        application for an exemption under section 520(g), including 
        documentation of significant controversies or differences of 
        opinion and the resolution of such controversies or differences 
        of opinion.''.
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