Briefs

Senators Introduce Bipartisan Bill to Repeal Device Tax

Sens. Pat Toomey (R-Penn.) and Amy Klobuchar (D-Minn.) introduced legislation, the Protect Medical Innovation Act (S. 692), that would end the nationwide medical device tax.

The 2.3 percent medical device excise tax — a tax paid whenever a purchase is made — became active in 2013. In July 2018, the House voted to permanently repeal the tax, with 283 members of Congress voicing their support for revocation.

AdvaMed strongly opposes the tax, arguing that it should be repealed so the industry can “make the multi-year investments in R&D and infrastructure necessary to sustain the innovation ecosystem and take the next leap forward in patient care.”

Administration Seeks $55 Million for Device Database in Fiscal 2020

The Trump administration’s budget request for fiscal year 2020 calls for $55 million for a safety database that the FDA says will allow the agency to track a device through its total lifecycle.

The FDA is one of the few government agencies that would get a bump in federal spending under the administration’s fiscal 2020 budget request.

“This capability to better leverage pre-existing and new data in near real time is essential for implementing the FDA’s new approaches for digital health technologies, breakthrough devices, use of real-world evidence and cybersecurity,” the agency said. “Overall, this will make medical device reviews, post-market surveillance and cybersecurity efforts significantly more efficient and informative.”

FDA Promises Draft Guidance on Staplers

The FDA said it plans to issue draft guidance on surgical staplers and implantable staples as reports of nasty side effects continue to mount.

The agency said it wants manufacturers to include labeling to improve the safety record of the devices that have become common in surgery. Between 2011 and 2018, medical staples have been associated with 41,000 adverse events, including 366 deaths and more than 9,000 serious injuries, the FDA said in a letter to healthcare providers.

The agency said it will host an open meeting of its General and Plastic Surgery Devices Panel Advisory Committee following the release of the draft guidance.

FDA Reclassifies Contraception Software as Class II (Special Controls)

The FDA reclassified software applications for contraception as Class II medical devices with special controls, making them exempt from premarket notification requirements.

The agency moved the device type from automatic Class III into Class II (special controls) because it determined that the change “will provide a reasonable assurance of safety and effectiveness.”

The special controls include clinical performance testing to show the software’s effectiveness and human factors testing to show users can correctly use the application based on the directions for use. Other controls include software verification, validation and a hazard analysis.

Brain Implant Trials May Need to Include Home Use

Sponsors of brain implant trials seeking an investigational device exemption may be asked to demonstrate that their devices can work in “realistic home use environments,” the FDA said in a new draft guidance.

In general, the FDA doesn’t grant IDEs for brain implants because it considers them significant-risk devices. But the agency may consider granting exemptions to trials of implants aimed at repairing catastrophic spinal damage or lost limbs if sponsors can show in their protocols that their trials approximate “realistic home-use environments.”

Read the draft guidance here: www.fdanews.com/02-28-19-Brainimplant.pdf.