Devices & Diagnostics Letter

Devicemakers praised FDA efforts to craft guidance on the agency’s refuse-to-accept policy for 510(k) premarket notification submissions, but took issue with many specifics, including what would happen if a backlog causes the FDA to miss its proposed 15-day timeline.

A recent Government Accountability Office (GAO) report on healthcare fraud shows a high prevalence of fraud and abuse in the durable medical equipment (DME) sector.

The International Medical Device Regulators Forum (IMDRF) has approved a draft document outlining standards for international recognition of groups auditing devicemakers, an FDA official who attended the group’s recent meeting in Sydney, said.

Slowed uptake of the Sapien transcatheter heart valve led Edwards Lifesciences to issue advance warning last week of disappointing third-quarter sales.

The FDA and Centers for Medicare and Medicaid Services (CMS) continue to struggle — and often fail — to meet statutory deadlines for approving Class III devices and issuing national coverage decisions (NCD), according to a paper in the October issue of Health Affairs that looked at median approval times since the mid-1990s.

A new Democrat-supported bill on Capitol Hill that would require more sponsors to publicly register and report the results of clinical trials draws attention to NIH’s failure to release proposed rules on ClinicalTrials.gov following the site’s expansion five years ago under the FDA Amendments Act (FDAAA).

First Medical Source, a Laguna Beach, Calif., company that assembles pain management kits and distributes infusion supplies, has been warned for design control failures and other quality system violations.

CooperSurgical subsidiary Norland got FDA closeout on a warning letter the company received for deviations in complaint handling and good manufacturing practices at its Fort Atkinson, Wis., plant.

Early comments on the FDA’s unique device identification (UDI) rule reveal several priority items for devicemakers.

New South Korean requirements for medical devices introduced this year have made the country’s strict regulation of foreign devicemakers a bit more rigorous, an expert says.