S 1700: Medical Device Regulatory Improvement Act

LEGISLATIVE INFORMATION PAGE

Bill Number: S. 1700

Title: Medical Device Regulatory Improvement Act
Author: Klobuchar (D-MN) 2 Co-sponsors (Burr, Bennet)
Introduced: 10/13/11; Referred to HELP Committee

Summary:
1) The bill would change and clarify directives to the FDA Secretary regarding key language in the premarket approval process:

“Least Burdensome”
The bill clarifies provisions requiring the least burdensome means of determining device effectiveness, by directing the Secretary to:

• Not request information unrelated or irrelevant to demonstrating reasonable assurance of safety and effectiveness
• Consider alternative evaluation techniques in order to reduce time, effort and cost
• Use all reasonable mechanisms to lessen review times and render decisions
• Determine whether pre-clinical data including bench or animal testing can meet threshold for approval
• Rely on alternatives to randomized clinical trials when practicable

“Substantial Equivalence Determinations”
The bill adds directives to the FDA’s process for making substantial equivalence determinations by requiring the Secretary to:

• Focus on whether the device has the same intended use as the predicate device and is as safe and effective as a legally marketed device
• Not request or accept information unrelated to substantial equivalence evaluation
• Limit review of devices to the intended use as described on a product’s label
• Consider alternative approaches to evaluating substantial equivalence which reduce time, effort and cost
• Use all reasonable mechanisms to lessen review times and render decisions

2) The bill also relaxes current rules about FDA federal advisory committees by requiring them to adhere to standard Ethics in Government Act rules.

3) Lastly, the bill would require a review of the management and regulatory processes at the Center for Devices and Radiological Health to ensure that actions taken by the Center take into consideration the potential impacts on innovation with respect to devices.

CHI Position:	Learn More about S 1700:

California Delegation Co-Sponsors:

None