A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications.
Latest action · Feb 15, 2017 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedFeb 15, 2017
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
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.Cosponsors 3
Members who signed on, in the order they did. Signatures ran from Feb 15, 2017 to Apr 27, 2017, with 1 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-CO | Michael F. Bennet | Original | Feb 15, 2017 |
| D-IN | Joe Donnelly | Apr 27, 2017 | |
| R-IN | Todd Young | Apr 27, 2017 |
Actions 2
Everything that happened, newest first.
- Feb 15, 2017Introduced in Senate
- Feb 15, 2017Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 1736 | To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. | Identical bill | Mar 31, 2017 |
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Feb 15, 2017Introduced in Senate
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.