Medical Devices

FDA is launching a broad effort to revisit implantable device regulation in light of a growing body of data that shows material in some devices could harm certain patients, according to outgoing agency chief Scott Gottlieb and device center head Jeff Shuren.

Several medical device industry lawyers say FDA guidance that outlines how companies can seek feedback on actions they propose to correct problems found during inspections puts industry in a quandary.

As speculation of who could be confirmed to permanently replace FDA Commissioner Scott Gottlieb circulates among the media and stakeholders, consumer advocates say they would prefer someone who has fewer ties to industry while one industry consultant hopes the next commissioner will be an outsider who has familiarity with data and technology yet can still work within the guardrails of FDA.

National Cancer Institute Director Ned Sharples will become acting commissioner of FDA when current Commissioner Scott Gottlieb resigns in early April, HHS Secretary Alex Azar announced at a House hearing Tuesday (March 12).

The medical device lobby applauded a bill rolled out by a bipartisan duo of senators on Thursday (March 7) that would do away with the Affordable Care Act’s 2.3 percent excise tax on 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.