close
114th Congress: We're updating with new data as it becomes available.

H.R.3209 - Premarket Predictability Act of 2011

To amend the Federal Food, Drug, and Cosmetic Act to provide predictability, consistency, and transparency to the premarket review process. view all titles (2)

All Bill Titles

  • Official: To amend the Federal Food, Drug, and Cosmetic Act to provide predictability, consistency, and transparency to the premarket review process. as introduced.
  • Short: Premarket Predictability Act of 2011 as introduced.

This Bill currently has no wiki content. If you would like to create a wiki entry for this bill, please Login, and then select the wiki tab to create it.

Bill’s Views

  • Today: 2
  • Past Seven Days: 6
  • All-Time: 2,225
 
Introduced
 
House
Passes
 
Senate
Passes
 
President
Signs
 

 
10/14/11
 
 
 
 
 
 
 

Sponsor

S000364

Representative

John Shimkus

R-IL

View Co-Sponsors (20)

Official Summary

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)

Official Summary

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.

...Read the Rest




Vote on This Bill

-% Users Support Bill

0 in favor / 0 opposed
 

Send Your Rep a Letter

about this bill Support Oppose Tracking
Track with MyOC