Devices & Diagnostics Letter

SEATTLE — The FDA is considering the creation of a new Division of International Compliance Operations within CDRH’s Office of Compliance (OC) as part of the center’s efficiency drive and the agency’s increased international focus, CDRH officials say.

A majority of devicemakers are unhappy with the way CDRH handles 510(k) submissions, according to a study by the Minnesota Medical Device Alliance (MMDA).

Zimmer may pay less next year to comply with the medical device excise tax than previously anticipated, Chief Financial Officer James Crines told investors in an Oct. 25 third quarter earnings call.

Organizations that audit device establishments must ensure their findings document conformity, nonconformity or potential nonconformity with established best practices based on objective evidence, according to a draft standard released by the International Medical Device Regulators Forum (IMDRF).

SEATTLE — While the degree of risk and a company’s history dictate the level of regulatory scrutiny a device recall audit gets, recall strategies are expected to document supply chain communications down to the patient, FDA and Health Canada officials say.

The FDA is pushing back its goal dates for some device, drug and biologic applications by up to two days following the closure of FDA offices on Oct. 29 and 30 due to Hurricane Sandy.

Hospira is voluntarily recalling an infusion pump due to reports the device’s touch screen control panel may become unresponsive, according to a recent FDA bulletin.

The Centers for Medicare & Medicaid Services (CMS) should insert a self-referral flag on its Medicare Part B claims form to identify providers who are self-referring advanced imaging services — a trend that is costing the government millions, a new Government Accountability Office (GAO) report concludes.

Renal denervation may be the cardio growth story of the next several years, analysts who attended last month’s Transcatheter Cardiovascular Therapeutics (TCT) Conference in Miami predict.