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HR 1736 115th Congress House Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Health technology, devices, supplies Manufacturing

To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.

Introduced: March 27, 2017 See on congress.gov
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This bill died when the 115th Congress ended
It never became law before the 115th Congress (2017–2018) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 31, 2017
Referred to the Subcommittee on Health.
Mar 27, 2017
Referred to the House Committee on Energy and Commerce.
Mar 27, 2017
Introduced in House
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 Plain-English summary Congressional Research Service

This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding Food and Drug Administration (FDA): (1) inspections of establishments that manufacture or process medical devices, and (2) certification of medical devices for export.

The biannual inspection schedule for medical device establishments handling higher risk devices is replaced with a risk-based schedule. In establishing the risk-based schedule, the FDA must consider an establishment's participation in international medical device audit programs.

The FDA must adopt a uniform process and uniform standards for inspections of domestic and foreign medical device establishments.

Upon request, the FDA must provide to the person in charge of a medical device establishment feedback regarding the person's proposals to address issues identified during an inspection.

The FDA must provide the basis for denying requests for certification of products for export as meeting FDA requirements for domestic products. A person denied such a certification may request supervisory review of that decision.

Products from a medical device establishment that an inspector found to be contaminated or insanitary may be certified for export if the person in charge of the establishment has agreed to a plan to correct the issues identified during the inspection.
What's happening now March 31, 2017

Referred to the Subcommittee on Health.

 Related & companion bills 1
  • S 404 Identical bill A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishment…
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 6
All 6 Democratic 2 Republican 3
D
Gottheimer, Josh
New Jersey · Jun 21, 2017
 R
Hudson, Richard
North Carolina · Apr 27, 2017
 R
Banks, Jim
Indiana · Apr 25, 2017
 R
Blackburn, Marsha
Tennessee · Apr 14, 2017
Brooks, Susan
· Mar 27, 2017
 D
Peters, Scott H.
California · Mar 27, 2017
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 1736: To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.. 115th Congress. Open America. https://openamerica.io/bill/115-HR-1736/
MLA
"H.R. 1736: To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.." 115th Congress, 2026, Open America, https://openamerica.io/bill/115-HR-1736/.
Bluebook (legal)
H.R. 1736, 115th Cong. (2026), https://openamerica.io/bill/115-HR-1736/.
Markdown link
[H.R. 1736: To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.](https://openamerica.io/bill/115-HR-1736/)
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