Bill Summary
This is a bill that seeks to amend the Federal Food, Drug, and Cosmetic Act to provide exemptions for non-invasive diagnostic devices from regulation as medical devices. It also defines the term "non-invasive" and outlines the criteria that a device must meet in order to be considered non-invasive. The purpose of this bill is to promote medical innovation and make it easier for non-invasive diagnostic devices to enter the market without strict regulatory barriers. It is also known as the "Medical Innovation Acceleration Act of 2020".
Possible Impacts
1. This legislation could potentially benefit individuals who rely on non-invasive diagnostic devices for their healthcare needs as it exempts these devices from regulation. This could make these devices more accessible and affordable for individuals who may not have had access to them before due to strict regulations.
2. On the other hand, this legislation could also have negative effects on individuals who rely on these devices if the exemption from regulation leads to a decrease in quality control and safety standards. This could potentially put individuals at risk of using faulty or ineffective diagnostic devices.
3. The inclusion of the definition of "non-invasive" in this legislation could also affect individuals, as it sets specific criteria for what qualifies as a non-invasive diagnostic device. This could impact the availability of certain types of diagnostic devices and limit options for individuals who may require more invasive procedures for their healthcare.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6925 Introduced in House (IH)]
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116th CONGRESS
2d Session
H. R. 6925
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
May 19, 2020
Mr. Biggs introduced the following bill; which was referred to the
Committee on Energy and Commerce
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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 2020''.
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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