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 · introduced 2017-03-27 · Health · Latest: Referred to the Subcommittee on Health.

federal

Follow this bill, step by step

Where it came from: introduced 2017-03-27 · official record
Who proposed it: Rep. Bucshon, Larry [R-IN-8] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Referred to the Subcommittee on Health. Not final yet: this can still change. We check for updates every day.
If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

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

Plain summary

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.

Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

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What does this mean? (plain words)

Official text

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

Source: Congressional Research Service summary (Introduced in House)

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Bucshon, Larry [R-IN-8] · 8 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Scott H. Peters (D-CA), Marsha Blackburn (R-TN), Jim Banks (R-IN), Richard Hudson (R-NC), Josh Gottheimer (D-NJ)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (1)

Bill: A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).

Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Introduced in House)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-115hr1736.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/115/hr>

Record fed-us-cong115-hr1736 · catalog fed-us-congress-bills-cong115 · updated 2026-11-15 by psicol fed-bills-cong115