US Congress House Bill 3209 (Prior Session Legislation)

---

October 18 2011 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

Premarket Predictability Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to assign a tracking number to a medical device upon submission of: (1) an application for an exemption of a device for investigational use, (2) a request to classify a device, or (3) a premarket report or notification related to a device. Requires the Secretary to use the tracking number to record interactions between the Secretary and applicant with respect to the device. Directs the Secretary to: (1) assign a reviewer with prior review experience with the type of of device or technology involved or other relevant expertise to review an application for an exemption of a device for investigational use, and (2) evaluate whether the investigational study can be conducted ethically with reasonable risk in determining whether to grant an exemption for investigational use. Prohibits the Secretary from disapproving an application because the investigation does not or may not meet any requirement relating to the approval or clearance of a device because the Secretary believes that a different clinical testing design or plan could produce data more relevant to an approval or clearance decision. Revises the procedures relating to submission of an application to investigate a class II or a class III device, which may include a plan for determining whether the device is substantially equivalent to or is at least as safe and effective as a legally marketed device that is not subject to premarket approval requirements. Sets forth requirements for the Secretary to meet in determining the least burdensome appropriate means of evaluating medical device effectiveness that would have a reasonable likelihood of resulting in approval. Requires the Secretary to document the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding device review, approval, or exemption. Sets forth appeal procedures. Requires the Secretary to regularly publish detailed decision summaries for each clearance of a device not requiring premarket approval.

Premarket Predictability Act of 2011

Rep Shimkus, John	Rep Akin, W. Todd	Rep Altmire, Jason	Rep Barton, Joe
Rep Benishek, Dan	Rep Bilbray, Brian P.	Rep Blackburn, Marsha	Rep Burgess, Michael C.
Rep Cassidy, Bill	Rep Culberson, John Abney	Rep Gingrey, Phil	Rep Guthrie, Brett
Rep Lance, Leonard	Rep Latta, Robert E.	Rep Matheson, Jim	Rep McMorris Rodgers, Cathy
Rep Mulvaney, Mick	Rep Paulsen, Erik	Rep Rogers, Mike J.	Rep Rokita, Todd
Rep Walden, Greg

Date	Chamber	Action
2011-10-18	House	Referred to the Subcommittee on Health.
2011-10-14	House	Referred to the House Committee on Energy and Commerce.

Type	Source
Summary	http://thomas.loc.gov/cgi-bin/bdquery/z?d112:HN03209:@@@L&summ2=m&
Text	http://gpo.gov/fdsys/pkg/BILLS-112hr3209ih/pdf/BILLS-112hr3209ih.pdf