Medical Devices

A leading pediatric neurologist said he welcomed FDA’s approval of the first-ever device for treating attention-deficit/hyperactivity disorder (ADHD).

CMS proposes raising the add-on pay for new technology and providing a path for breakthrough devices approved by the FDA to access add-on payments as part of the proposed fiscal 2020 hospital inpatient pay rule released Tuesday (April 23) -- a move the medical device lobby praised for including several of the industry’s suggestions.

A month after reporting it received tens of thousands of adverse events associated with surgical staplers and staples, FDA is stepping up its regulation of the devices by: issuing a proposed order to upclassify the Class I devices as Class II; issuing draft guidance on labeling recommendations to ensure adequate use; and scheduling a public meeting on May 30 to gather input on the first two efforts.

As part of a broader effort to reconsider its regulation of implantable medical devices, FDA on Thursday (April 18) announced the release of a draft guidance detailing the types of information manufacturers should include in premarket submissions for devices containing nitinol, an alloy of nickel and titanium.

Sources say a memo by the White House Office of Management and Budget that requires federal agencies submit non-binding guidance to the Office of Information and Regulatory Affairs -- and potentially to Congress -- could throw a wrench in FDA’s usual guidance-making process, which could negatively affect both the agency and industry.

Device stakeholders have another 30 days to comment on FDA’s proposal to post on its website cleared devices that demonstrated substantial equivalence to older predicate devices as part of its bid to encourage device makers to use new predicates.

Since his early March announcement that he would be leaving FDA, former agency commissioner Scott Gottlieb ramped up work to wrap up, or initiate, myriad goals he wanted to accomplish during his time with the agency.

American Clinical Laboratory Association (ACLA) president and CEO Julie Khani said she looks forward to starting a dialogue with FDA to refine aspects of a draft bill that would redefine the agency’s regulatory authority over diagnostics.

FDA Commissioner Scott Gottlieb says his agency is looking into less environmentally hazardous methods of medical device sterilization after the Illinois Environmental Protection Agency ordered a large sterilization facility to close in February due to ethylene oxide emissions.