Title: Realizing Intended Safety for Certain 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]
[S. 1070 Introduced in Senate (IS)]

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115th CONGRESS
  1st Session
                                S. 1070

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 8, 2017

 Mr. Roberts (for himself, Mr. Donnelly, and Mr. Burr) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


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

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Realizing Intended Safety for 
Certain Accessories Act of 2017''.

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--
            (1) by striking ``(9) The Secretary'' and inserting 
        ``(9)(A) The Secretary''; and
            (2) by adding at the end the following:
    ``(B) The classification of any accessory classified prior to 
December 13, 2016, based on the intended use or uses of such accessory, 
shall continue to apply, notwithstanding the classification of any 
other device with which such accessory is intended to be used.
    ``(C)(i) If--
            ``(I) an accessory has been cleared or approved based on 
        the classification of another device with which such accessory 
        is intended to be used; and
            ``(II) the Secretary has established a classification for 
        such accessory based on the intended use or uses of the 
        accessory, in accordance with subparagraph (A),
the manufacturer of such accessory may identify the classification 
described in subclause (II) in a written notification to the Secretary.
    ``(ii) Unless the Secretary notifies a manufacturer within 30 
calendar days of receipt of a written notification described in clause 
(i) that the Secretary does not agree that the classification 
identified in such written notification is appropriate for the 
accessory, the accessory shall be automatically reclassified in 
accordance with the classification identified in such written 
notification.
    ``(iii) A written notification that the Secretary disagrees with 
the classification identified in a written notification described in 
clause (ii) shall include a detailed description and justification for 
the determination to disagree.
    ``(D)(i) A manufacturer of an accessory that has been previously 
classified by the Secretary based on the intended use of another device 
with which the accessory is intended to be used, through an application 
for such other device under section 515(c), a report under section 
510(k), or a petition for classification under section 513(f)(2), and 
that has not been classified by the Secretary based on the intended use 
or uses of the accessory as described in subparagraph (A) or (C), may 
submit to the Secretary a written recommendation for the appropriate 
classification of such accessory based on its intended use or uses. 
Such submission shall include such information to support the 
recommendation as the Secretary may require.
    ``(ii) The Secretary shall respond to a submission under clause (i) 
within 60 calendar days by approving or denying the recommended 
classification of the accessory. If the Secretary does not agree with 
the recommendation for classification submitted by the sponsor, the 
response shall include a detailed description and justification for 
such determination to disagree. The Secretary shall provide an 
opportunity for a manufacturer to meet with appropriate personnel to 
discuss appropriate classification of such accessory prior to 
submitting a written recommendation.
    ``(E) At the time a sponsor submits an application for premarket 
approval for a class III device pursuant to section 515(c), the sponsor 
of such application may include a recommendation and supporting 
information for the proper classification of such accessory pursuant to 
subparagraph (A). If such device is intended to be used with an 
accessory that has not been classified by the Secretary based on its 
intended use or uses as described in subparagraph (A) or (C), the 
Secretary shall--
            ``(i) approve or deny the application pursuant to section 
        515(d); and
            ``(ii) approve or deny the classification of the accessory 
        proposed in the application submitted under this clause.
    ``(F) A manufacturer may at any time use the classification process 
described in section 513(f)(2) to obtain classification of an 
accessory.''.
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