Medical Devices

A device industry lawyer expressed guarded confidence in a draft guidance FDA released last month that aims to revamp the agency’s 510(k) third-party review program, where qualified organizations review 510(k) submissions for certain low-risk devices.

The national drug and device lobbies this week weighed in on a Utah Supreme Court case that could determine whether FDA approval of a medical device shields the product's manufacturer from strict liability claims over alleged design defects.

Three Democratic senators wrote to top FDA officials Wednesday (Oct. 10) that they have “serious concerns” about the agency's emerging precertification program, where precertified software developers would not be subject to premarket review.

An array of stakeholders voiced their support for the cross-industry role laid out in a set of sweeping cybersecurity initiatives unveiled by FDA Commissioner Scott Gottlieb this week, including new cybersecurity information sharing agreements, a playbook for hospitals to prepare for cybersecurity breaches and plans for an updated agency guidance document.

CMS on Wednesday (Oct. 3) unveiled several changes to the local coverage determination process, including a way to request such a determination, repurposed public meetings and a reconsideration process that is consistent with that used for national coverage determinations.

FDA Commissioner Scott Gottlieb announced three new initiatives aimed at increasing cybersecurity preparedness and information-sharing among medical device stakeholders, particularly among health care delivery organizations (HDOs) such as hospitals.

A provision expanding the sunshine law to require drug and medical device makers publicly disclose payments made to health care providers beyond doctors made it into the final version of an opioid bill unveiled by House and Senate negotiators on Tuesday (Sept. 25), despite opposition from the medical device lobby.

The Advanced Medical Technology Association (AdvaMed), the American Hospital Association and American College of Cardiology are concerned that aspects of FDA's Medical Device Safety Action Plan – including a voluntary 510(k) program for moderate-risk devices and a required software bill of materials (SBOM) – could create more medical device safety issues than it would solve, according to comments the groups recently submitted to FDA's docket.

A federal Judge on Friday dismissed a suit against Kaiser Permanente that charged the issuer's decision to cover cochlear implants but not hearing aids violated the Affordable Care Act's 1557 non-discrimination provisions, which bars plans from discriminating on the base of race, disability, color, national origin, sex, or transgender status.