Devices & Diagnostics Letter

CDRH officials plan a series of public forums in 2012 to gather data to develop an implementation plan for the center’s Case for Quality Initiative – which aims to create an ongoing culture of quality at medical device manufacturers.

The Senate plans to debate and vote on an omnibus FDA user fee bill this week, after lawmakers substituted a new bill for the prior reauthorization package and began discussing it on Thursday.

The current round of FDA user fee reauthorizations stands to save the federal government $71 million by 2017, and $358 million by 2022, according to a recent congressional analysis.

Devicemakers used a Wednesday Internal Revenue Service public hearing to continue their crusade against next year’s launch of the medical device excise tax, calling it burdensome and ill-conceived.

The FDA is advising physicians and clinical trial sites that may be studying an experimental procedure for multiple sclerosis (MS) that they need to get investigational device exemption (IDE) approval to proceed.

An anticipated Federal Communications Commission (FCC) rule change broadening the spectrum available to medical devices could significantly alter patient monitoring, industry and government representatives say.

Makers of low-risk weight loss devices may be able to test them on less obese patients if the FDA heeds recommendations made by its Gastroenterology and Urology Devices Panel.

Amplivox, a UK subsidiary of Danish company William Demant, received a warning letter from the FDA following a December inspection of its Oxford manufacturing plant.

As devicemakers work with increasing numbers of companies in the supply chain, their risks of liability rise, making it imperative they have contracts and auditing policies in place to avoid costly lawsuits, recalls and adverse publicity, a product liability expert says.

While FDA reviewers are supposed to meet general timelines, meeting specific medical product review goals is generally not part of employee performance plans, a March 18 Government Accountability Report (GAO) finds.

Devicemakers and the rest of the scientific community can and should benefit from the careful disclosure of FDA review data that industry and the agency currently keep closely guarded, FDA Commissioner Margaret Hamburg says.