Premarket Predictability Act of 2011

[AI summary unavailable — showing source text] 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 …