[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6513 Introduced in House (IH)]

<DOC>






117th CONGRESS
  2d Session
                                H. R. 6513

   To amend the Federal Food, Drug, and Cosmetic Act to exempt from 
 regulation as devices non-invasive diagnostic devices, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 28, 2022

  Mr. Biggs 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 exempt from 
 regulation as devices non-invasive diagnostic devices, and for other 
                               purposes.

    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 ``Medical Innovation Acceleration Act 
of 2022''.

SEC. 2. EXEMPTING NON-INVASIVE DIAGNOSTIC DEVICES FROM REGULATION AS 
              DEVICES.

    Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(h)) is amended--
            (1) in the second sentence by inserting before the period 
        at the end the following: ``or any non-invasive diagnostic 
        device''; and
            (2) by adding at the end the following: ``For purposes of 
        the preceding sentence, the term `non-invasive' means, with 
        respect to a diagnostic device, that the device does not 
        penetrate the skin or any other membrane of the body, is not 
        inserted or implanted into the body, causes no more than 
        ephemeral compression or temperature changes to in situ bodily 
        tissues, and does not subject bodily tissues to ionizing 
        radiation.''.
                                 <all>