Medical Devices

FDA device center chief Jeff Shuren says that his agency, in order to consistently be the best in the world at identifying and responding to device safety signals, will need more resources to fuel its real-world evidence-gathering apparatus, the National Evaluation System for health Technology (NEST) and its coordinating center (NESTcc).

FDA on Tuesday (Nov. 13) moved toward fulfilling provisions in the 21st Century Cures Act that allow FDA to waive or alter informed consent regulations for minimal risk clinical investigations as long as there are appropriate human subject protections in place.

Drug industry lawyers are calling for FDA to give more specific feedback during new product reviews to drug applicants, saying the agency’s current process leaves out crucial details and makes the process more frustrating and contentious than necessary.

With a Democratic takeover of the House, the powerful Energy & Commerce Committee will experience leadership and priority shifts. A former congressional aide told Inside Health Policy that Democrats may use the opportunity to push the Creating and Restoring Access to Equivalent Samples (CREATES) Act, seek funding options for opioid-related initiatives, focus more on cosmetics legislation and revisit laboratory-developed test (LDT) legislation.

The Advanced Medical Technology Association (AdvaMed) is confident that the interests of the medical device industry will be well-represented no matter which party controls the House and the Senate after the midterm elections due to the industry's support from both parties.

HHS has rebranded its cybersecurity center to distinguish it in the department's efforts to defend the health care sector's information technology infrastructure, an HHS spokesperson told Inside Health Policy.

CMS is working on a rule to streamline Medicare coverage of breakthrough medical technologies, according to the agency's most recent regulatory agenda, which was unveiled shortly after CMS Administrator Seema Verma complained about Medicare's inability to quickly cover devices.

FDA is planning to move on a range of deregulatory actions in the medical device space, including implementing the timeframes and procedures for how the agency handles internal review of device-related decisions; no longer publishing lists of certain device approvals and denials; and harmonizing domestic and international quality requirements for devices.

A device industry lawyer expressed guarded confidence in a draft guidance FDA released last month that aims to revamp the agency’s 510(k) third-party review program, where qualified organizations review 510(k) submissions for certain low-risk devices.