FDA Renewing Efficiency From Outside Reviewer Management Act of 2011
Latest action · Oct 18, 2011 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.
- IntroducedOct 14, 2011
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise and extend through October 1, 2017, provisions authorizing accredited persons to provide classification reports for a medical device and to inspect class II device or class III device facilities.
Deems a recommendation of an accredited person as to the classification of a medical device to be accepted by the Secretary of Health and Human Services (HHS) if the Secretary fails to make a determination with respect to the recommendation within 30 days.
Requires the Secretary to regularly publish: (1) detailed decision summaries for each clearance of a device, classification of a device, approval of an application of a device, or grant of exemption for a device occurring after the enactment of this Act; and (2) total product life cycles information for devices.
Expands the devices for which an accredited person may perform a review to include: (1) a class II device for which clinical data is required in the report, and (2) a class II device which is intended to be permanently implantable or life sustaining or supporting only if notification is provided to the Secretary before such a review. Deems the review permissible if the Secretary does not object within 60 days.
Requires the Secretary to provide for the initial training and periodic updating of training of accredited persons.
Makes accreditation valid for three years. Sets forth provisions regarding reaccreditation.
Prohibits an accredited person from being a sole practitioner. Provides that the prohibitions against an accredited person being owned or controlled by a manufacturer, supplier, or vendor of devices or engaging in the design, manufacture, promotion, or sale of devices shall apply only if the devices are of the same type for which the person is accredited.
Cosponsors 16
Members who signed on, in the order they did. Signatures ran from Oct 14, 2011 to Jan 23, 2012; 13 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-IL | Adam Kinzinger | Original | Oct 14, 2011 |
| R-LA | Bill Cassidy | Original | Oct 14, 2011 |
| R-KY | Brett Guthrie | Original | Oct 14, 2011 |
| R-CA | Brian P. Bilbray | Original | Oct 14, 2011 |
| R-WA | Cathy McMorris Rodgers | Original | Oct 14, 2011 |
| R-MN | Chip Cravaack | Original | Oct 14, 2011 |
| D-PA | Jason Altmire | Original | Oct 14, 2011 |
| R-MN | John Kline | Original | Oct 14, 2011 |
| R-IL | John Shimkus | Original | Oct 14, 2011 |
| R-TN | Marsha Blackburn | Original | Oct 14, 2011 |
| R-CA | Mary Bono | Original | Oct 14, 2011 |
| R-MN | Michele Bachmann | Original | Oct 14, 2011 |
| R-OH | Robert E. Latta | Original | Oct 14, 2011 |
| R-TX | Michael C. Burgess | Oct 25, 2011 | |
| R-TX | John Abney Culberson | Dec 2, 2011 | |
| R-IN | Todd Rokita | Jan 23, 2012 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Oct 14, 2011 |
| Health Subcommittee | Referred Oct 18, 2011 |
Actions 3
Everything that happened, newest first.
- Oct 18, 2011Referred to the Subcommittee on Health.
- Oct 14, 2011Introduced in House
- Oct 14, 2011Referred to the House Committee on Energy and Commerce.
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Constitutional authority
The sponsor’s statement, as printed in the page H6977.
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To amend the Federal Food, Drug, and Cosmetic Act with respect to persons who, with respect to devices, are accredited to perform certain reviews or inspections.
- Short Titles as Introduced
- FDA Renewing Efficiency From Outside Reviewer Management Act of 2011
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Oct 14, 2011Introduced 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; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
