Medical Devices

A bipartisan House bill introduced last Thursday (Feb. 28) would give Medicare and Medicaid beneficiaries greater access to their health care records via mobile apps, supporting a proposed rule released by CMS in early February requiring some plans to test application programming interface (API) for health information and to make provider networks available via API.

Within hours of the announcement that FDA Commissioner Scott Gottlieb will be resigning from the agency in a month, an array of stakeholders sent out their near-universal applause of the commissioner’s leadership and policy initiatives.

The medical device lobby applauded a bill that would let FDA collect new user fees during a lapse in agency funding, allowing the agency to continue reviewing device applications in the event of a future government shutdown.

Officials from FDA’s device center say it is too early to answer many of industry’s questions about the agency’s nascent digital health software precertification program, including those asking what new authority FDA needs to implement the program.

FDA stakeholders are applauding the $269 million increase in FDA funding included in a government spending package passed by Congress Thursday (Feb. 14) to avert another shutdown.

Device industry lawyers believe FDA’s move toward allowing use of objective performance criteria to evaluate certain new medical devices, rather than relying on predicate devices, could improve the agency’s 510(k) process by creating a more streamlined pathway for well-understood devices.

In keeping with the goals of the 21st Century Cures Act, FDA on Tuesday (Feb. 5) published draft guidance aimed at laying out predictable premarket review pathways for combination products.

A week after the temporary end of a month-long partial government shutdown, the stakes are high for FDA as lawmakers and the White House resume talks on a possible deal to fund the government when the short-term spending bill ends Feb. 15.

An official in FDA’s medical device center announced the agency has launched a new project intended to encourage device stakeholders to partner with cybersecurity researchers -- also called white hat hackers -- as a means of boosting the resilience, transparency and trustworthiness of medical devices and the health care system overall.