21st Century Cures Act Passes Senate, Several Impacts to Device Industry

By MedTech Intelligence Staff
December 12, 2016


• Categories: 04-Product Design & Development, 05-Quality/Regulatory, Combination Products, Market Access, RC - Medtech Regulatory Resource Center

–UPDATE December, 13, 2016: Today President Obama signed the 21st Century Cures Act into law. FDA Commissioner Robert Califf, M.D. provided comments on the Act in FDA Voice (the agency’s blog): “With Cures, great progress has been made towards our shared goal of advancing regulatory science so that we can continue to speed the discovery, development, and delivery of medical products to prevent and cure disease and improve health while sustaining the evidence framework that enables assurance to the public of the safety and effectiveness of medical products.”

–END UPDATE–

Last week the U.S. Senate passed the 21st Century Cures Act, a bill that supporters say will expedite the pathway way for medical technologies. Several provisions impact device manufacturers, including:

• Enhancing combination products review. FDA is charged with identifying the responsibilities of each center within the agency in charge of reviewing medical devices, drugs and biologics.
• Priority review for breakthrough devices.
• Improvements to the medical device regulatory process.
• Training staff in the review of premarket applications, applying a least burdensome approach.
• Expansion of humanitarian device exemptions.
• Institutional review boards charged with reviewing plans for clinical testing would not need to be in the same location as the trial.
• Improving FDA’s scientific expertise and outreach.

Read: Five Important Facts About 21st Century Cures Act

President Obama is expected to sign the bill into law.