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HR 3205 112th Congress House Health Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government information and archives Health technology, devices, supplies

FDA Renewing Efficiency From Outside Reviewer Management Act of 2011

Introduced: October 14, 2011 See on congress.gov
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 18, 2011
Referred to the Subcommittee on Health.
Oct 14, 2011
Referred to the House Committee on Energy and Commerce.
Oct 14, 2011
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now October 18, 2011

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2