S. 1622: FDA Device Accountability Act of 2016
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S. 1622: FDA Device Accountability Act of 2016
114th Congress · introduced 2015-06-18 · Health · Latest: Placed on Senate Legislative Calendar under General Orders. Calendar No. 426.
federal
Follow this bill, step by step
- Where it came from: introduced 2015-06-18 · official record
- Who proposed it: Sen. Burr, Richard [R-NC] · what a sponsor is
- What happened next: no floor votes in our records yet. Why?
- Where it stands now: Placed on Senate Legislative Calendar under General Orders. Calendar No. 426. 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
FDA Device Accountability Act of 2016
Plain summary
FDA Device Accountability Act of 2016 (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to eliminate the requirement for the Institutional Review Board supervising the clinical testing of an investigational or humanitarian medical device to be local. (Sec. 3) The Food and Drug Administration (FDA) must revise the guidance entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” (Sec. 4) The FDA must ensure that employees who review premarket submissions of medical devices receive training on least burdensome means requirements. (Currently, the FDA is required to consider the least burdensome appropriate means for a sponsor to demonstrate the effectiveness of a medical device or demonstrate a device’s substantial equivalence to an approved medical device.) The FDA must periodically assess the implementation of those requirements. The ombudsman for any applicable unit of the FDA must audit and report on the training. The FDA must consider the least burdensome appropriate means necessary to demonstrate medical device safety and effectiveness when requesting additional information from a device sponsor to support a premarket approval application, including the role of postmarket information in such a demonstration. The FDA’s documented rationale for a significant decision regarding a medical device must include a statement regarding how the least burdensome requirements were considered and applied.
Congressional Research Service summary (Reported to Senate with amendment(s)), 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.
PSI Sci description of the legislative step (not an opinion).
What does this mean? (plain words)
Official text
FDA Device Accountability Act of 2016
Source: Congressional Research Service summary (Reported to Senate with amendment(s))
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The strongest published arguments
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Alternatives
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How did my representative vote? · This bill's floor votes
Officials and money
Sponsor: Sen. Burr, Richard [R-NC] · 4 cosponsors
Cost estimate: CBO cost estimate: S. 1622, FDA Device Accountability Act of 2016 (2016-07-12)
Cosponsors on this site
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 (2)
- Appropriation
- Money a legislature sets aside by law for a specific purpose. Government agencies may spend public money only as it has been appropriated.
- 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 (Reported to Senate with amendment(s))
- Congress.gov
- Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-114s1622.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/114/s>
Record fed-us-cong114-s1622 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114