To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.
Latest action · Mar 31, 2017 Referred to the Subcommittee on Health.
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.
- IntroducedMar 27, 2017
- Passed HouseNot reached
- Passed SenateNot 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 8
Members who signed on, in the order they did. Signatures ran from Mar 27, 2017 to Jun 21, 2017, with 3 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-NC | G. K. Butterfield | Original | Mar 27, 2017 |
| D-CA | Scott H. Peters | Original | Mar 27, 2017 |
| R-IN | Susan W. Brooks | Original | Mar 27, 2017 |
| R-TN | Marsha Blackburn | Apr 14, 2017 | |
| R-IN | Jim Banks | Apr 25, 2017 | |
| R-NC | Richard Hudson | Apr 27, 2017 | |
| D-NJ | Josh Gottheimer | Jun 21, 2017 | |
| R-IN | Todd Rokita | Jun 21, 2017 |
Actions 3
Everything that happened, newest first.
- Mar 31, 2017Referred to the Subcommittee on Health.
- Mar 27, 2017Introduced in House
- Mar 27, 2017Referred to the House Committee on Energy and Commerce.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 404 | A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications. | Identical bill | Feb 15, 2017 |
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Mar 27, 2017Introduced in House
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.