Title: Risk-Based Classification of Accessories Act of 2017
Policy area: Health

Summary:
Risk-Based Classification of Accessories Act of 2017
This bill revises how accessories to medical devices are classified. Specifically, the Food and Drug Administration must classify accessories based on the risks when used as intended, notwithstanding the classification of any other device with which such accessory is intended to be used.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2144 Introduced in House (IH)]

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115th CONGRESS
  1st Session
                                H. R. 2144

 To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
 appropriate, risk-based classification of device accessories based on 
                          their intended uses.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 25, 2017

  Mrs. Mimi Walters of California (for herself and Ms. Kuster of New 
  Hampshire) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
 appropriate, risk-based classification of device accessories based on 
                          their intended uses.

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

SECTION 1. SHORT TITLE.

    (a) Short Title.--This Act may be cited as the ``Risk-Based 
Classification of Accessories Act of 2017''.
    (b) Findings.--The Congress finds that there is a need for an 
appropriate process for the timely classification of device 
accessories, in accordance with the 21st Century Cures Act (Public Law 
114-255), such that accessories are classified in accordance with their 
intended uses.

SEC. 2. RISK-BASED CLASSIFICATION OF ACCESSORIES.

    Section 513(b)(9) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360c(b)(9)) is amended to read as follows:
            ``(9)(A) Subject to the succeeding subparagraphs of this 
        paragraph, the Secretary shall classify an accessory under this 
        section based on the intended use of the accessory, 
        notwithstanding the classification of any other device with 
        which such accessory is intended to be used.
            ``(B) In the case of an accessory that, as of December 13, 
        2016, has been classified in accordance with subparagraph (A), 
        such classification shall continue to apply to such accessory.
            ``(C)(i) In the case of an accessory that has been cleared 
        under section 510(k) or approved under section 515 based on the 
        classification of another device with which such accessory is 
        intended to be used, and the Secretary has established a 
        classification for such accessory in accordance with 
        subparagraph (A), the manufacturer of such accessory may, in 
        lieu of submitting a request for classification of such 
        accessory, submit a written notification to the Secretary 
        identifying such classification.
            ``(ii) Unless the Secretary, not later than 30 days after 
        receiving a notification under clause (i), informs the 
        manufacturer involved that the Secretary does not agree that 
        the classification identified in such notification is 
        appropriate for the accessory, the accessory shall be 
        automatically reclassified in the classification so identified.
            ``(D)(i) In the case of a device intended to be used with 
        an accessory that has not been classified by the Secretary in 
        accordance with subparagraph (A), the person filing an 
        application for premarket approval of such device under section 
        515 or a report under section 510(k) for clearance of such 
        device, may, at the time such application or report (as 
        applicable) is filed, include with such application--
                    ``(I) a recommendation for the proper 
                classification of the accessory pursuant to such 
                subparagraph; and
                    ``(II) such appropriate information to support the 
                recommendation as may be specified by the Secretary.
            ``(ii) The Secretary's response under section 515(d) or 
        section 510(n) (as applicable) to an application or report 
        described in clause (i) shall also contain the Secretary's 
        approval or denial of the proposed classification of the 
        accessory involved.
            ``(iii) The Secretary's evaluation of an accessory under 
        clause (i) shall constitute an order establishing a new 
        classification for such accessory for the specified intended 
        use or uses of such accessory and for any accessory with the 
        same intended use or uses as such accessory.
            ``(E)(i) A manufacturer of an accessory that has been 
        previously classified by the Secretary based on the intended 
        use of another device with which such accessory is intended to 
        be used, through the approval of such other device under 
        section 515(c), the clearance of such device under section 
        510(k), or the submission of a petition for classification 
        under section 513(f)(2), and that has not been classified by 
        the Secretary in accordance with subparagraph (A), may make a 
        written submission to the Secretary containing a recommendation 
        for the appropriate classification of the accessory based on 
        the intended use or uses of the accessory. Such submission may 
        include appropriate information to support the recommendation 
        as may be specified by the Secretary.
            ``(ii) The Secretary shall respond to a submission made 
        under clause (i) not later than 60 days after receiving such 
        submission by approving or denying the recommended 
        classification of the accessory. The Secretary shall provide an 
        opportunity for a manufacturer to meet with appropriate 
        personnel of the Food and Drug Administration to discuss the 
        appropriate classification of such accessory prior to making a 
        written submission.
            ``(F) Nothing in this paragraph may be construed as 
        precluding a manufacturer of an accessory from using the 
        classification process described in section subsection (f)(2) 
        to obtain classification of such accessory.''.

SEC. 3. EFFECTIVE DATE.

    The amendment made by section 2 shall take effect on the date that 
is 60 days after the date of the enactment of this Act.
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