House Approves New Version of 21st Century Cures Bill

The House voted 392-to-26 to approve a new version of its 21st Century Cures bill — nearly a year-and-a-half after it passed its first version — which seeks to streamline the FDA’s review process for medical devices.

The legislation establishes a program to speed up development of devices featuring “breakthrough” technologies that are designed to diagnose or treat serious conditions and have no approved or cleared alternatives. The program builds on the FDA’s Expedited Access Pathway, chiefly by permitting access to 510(k) devices (IDDM, June 10).

J.C. Scott, head of government affairs for AdvaMed, said the program exemplifies a welcome culture change at the FDA. “Ever since [Medical Device User Fee Amendments] III, there have been better interactions between the FDA and medical technologies that are going through the review process,” he said. “Hopefully this bill and MDUFA IV will continue that positive trajectory.”

Gregory Daniel, deputy director of Duke-Margolis Center for Health Policy, also said the breakthrough device provision is promising, but cited the need for a good way to track performance. He noted that the FDA is taking steps in that direction with the Medical Device National Evaluation System for health Technology (NEST), which will generate real-world evidence across the total product lifecycle of medical devices. “This is a perfect example of the value that NEST can bring,” Daniel said.

The bill further requires the FDA to publish lists of Class I and Class II devices that no longer require 510(k) clearances. The lists are to be published every five years and public comments are to be allowed for the listed Class II devices.

The legislation also identifies five categories of medical software that would not be regulated as a medical device, including:

• Administrative support software, such as maintaining financial records;
• Programs designed to encourage a healthy lifestyle and are unrelated to the diagnosis and treatment of disease;
• Electronic patient records created by health care professionals and maintained by certified health information technology;
• Software for displaying clinical laboratory test results; and
• Software for displaying medical information about a patient, unless it processes or analyzes a medical image or signal from an in vitro diagnostic device.

The bill further requires the FDA to finalize its draft guidance on when a new 510(k) is required by November 2017 (IDDM, Nov. 11). In addition, it:

• Requires FDA reviewers to consider the least burdensome means necessary for demonstrating safety and effectiveness;
• Requires the FDA to recognize national or international standards for medical device review; and
• Removes the requirement that medical device trial sponsors always use a local institutional review board, which will allow the use of centralized models.

The Senate still has to pass the bill before it adjourns Dec. 16. The House originally passed it in July 2015. Its passage later stalled in the Senate, which produced 19 separate bills that made it out of committee but were not brought up for a full vote. However, Scott said that due to bipartisan support in the House and President Obama’s endorsement, he is optimistic that the bill will pass the Senate.

The full, 996-page bill is available here: www.fdanews.com/11-28-16-CenturyCures.pdf.