Medical Devices

The medical device industry may soon have more opportunities to use a faster premarket review program, thanks to proposals included in a draft FDA guidance that would expand the agency’s special 510(k) pathway for reviewing changes in certain devices.

The Advanced Medical Technology Association (AdvaMed) President and CEO Scott Whitaker is upset the Senate tucked into its recently passed opioid bill a provision expanding the sunshine law to require that drug and medical device makers also publicly disclose payments made to nurse practitioners, physician assistants and midwives – not just doctors and hospitals – for promotional talks, consulting and other interactions.

A White House budget official said that the administration is doing “a lot of work right now on medical device stuff that nobody knows about,” and that he hopes to see some of those ideas start coming from CMS in the next six months.

FDA’s recent proposal to establish “a collaborative community” of stakeholders to support the agency in its decision-making process for diagnostics regulation could also serve as “a compelling new paradigm” for the cancer research community, Commissioner Scott Gottlieb said at a Friends of Cancer Research event Thursday (Sept. 13).

A device industry lawyer said a draft guidance FDA issued Sept. 5 shows the agency is willing to accept greater premarket risk in the device development process, as long as postmarket controls and data collection procedures are in place.

The House on Wednesday (Sept. 12) is set to consider, likely under suspension of the rules, several bills passed by the Ways & Means Committee last week, including legislation to make CMS' Local Coverage Decision process more transparent and to direct HHS to finish updating regulations for the Programs of All-Inclusive Care for the Elderly, according to House Majority Leader Kevin McCarthy's (R-CA) weekly schedule.

The House Ways & Means Committee passed a tweaked version of a bill backed by the medical device industry to clarify and make CMS' local coverage determination process more transparent.

The House Ways & Means Committee passed four bipartisan health care bills on Wednesday (Sept. 5) -- which would test the use of smart cards to stem fraud, codify a Medicare enrollment fix, require final regulations for the Programs of All-Inclusive Care for the Elderly program and tweak the local coverage determination process -- but some Democrats complained the measures deal with problems on the periphery of Medicare and the health care system.

The American Clinical Laboratory Association (ACLA) and AdvaMedDx are raising concerns with a draft legislative proposal floated by FDA on Aug. 6 that would overhaul federal regulation of diagnostics, including laboratory-developed tests (LDTs) and in vitro diagnostics (IVDs). ACLA asks lawmakers to reject the proposal in its entirety, while AdvaMedDx calls for more discussion on the plan.