H.R. 818: DEVICE Act of 2019
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H.R. 818: DEVICE Act of 2019
116th Congress · introduced 2019-01-28 · Health · Latest: Referred to the Subcommittee on Health.
federal
Follow this bill, step by step
- Where it came from: introduced 2019-01-28 · official record
- Who proposed it: Rep. Lieu, Ted [D-CA-33] · 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.
Official title
DEVICE Act of 2019
Plain summary
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2019 or the DEVICE Act of 2019 This bill addresses design changes and reprocessing of medical devices. Reprocessing of medical devices is the process to clean and sterilize or disinfect devices for reuse. Specifically, medical device manufacturers must notify the Food and Drug Administration (FDA) (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device. A device may not be sold if the manufacturer violates these notification requirements. Rapid assessment tests intended to ensure the proper reprocessing of reusable medical devices are defined as medical devices. The FDA must publish a list of the types of rapid assessment tests for which premarket notification must include validated instructions for use and validation data.
Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.
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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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How did my representative vote? · This bill's floor votes
Officials and money
Sponsor: Rep. Lieu, Ted [D-CA-33] · 4 cosponsors
Cost estimate: No cost estimate published yet.
Cosponsors on this site
Judy Chu (D-CA), Eleanor Holmes Norton (D-DC)
Sponsor's campaign money: Rep. Lieu, Ted [D-CA-33] reported raising $2.2 million (2025–2026). Details. Shown for context only; it does not mean any donor supported this bill.
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-116hr818.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/116/hr>
Record fed-us-cong116-hr818 · catalog fed-us-congress-bills-cong116 · updated 2026-11-15 by psicol fed-bills-cong116