Medical Innovation Acceleration Act of 2022
This bill exempts noninvasive diagnostic devices from the regulatory authority of the Food and Drug Administration.
The bill defines noninvasive diagnostic device as one that 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.
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.''.
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Medical Innovation Acceleration Act of 2022
To amend the Federal Food, Drug, and Cosmetic Act to exempt from regulation as devices non-invasive diagnostic devices, and for other purposes.
Medical Innovation Acceleration Act of 2022
Rep. Biggs, Andy