Devices & Diagnostics Letter

The FDA last week released updated guidance describing how it intends to comply with submission review timelines set during user fee negotiations earlier this year.

Devicemakers can begin taking steps to comply with new electronic copy requirements for most types of FDA submissions, thanks to an FDA draft guidance.

A warning letter may be in St. Jude Medical’s future, company CEO Dan Starks announced during a Wednesday third quarter earnings call.

In vitro diagnostics (IVD) could claim the lion’s share of a $440 billion global medtech market in 2018, thanks to the rise of personalized medicine, a new report by London consulting group EvaluateMedTech says.

The European Commission is urging that medical devices containing nanomaterials be reclassified as Class III devices and subject to the “most severe conformity assessment,” due to risk of particles being released into the human body.

Medicare’s prosthetics and custom orthotics program is surprisingly abuse-free, despite the Centers for Medicare & Medicaid Services’ (CMS) failure to issue legislatively mandated regulations, according to a report by the HHS Office of the Inspector General (OIG).

Quality system violations at Alere’s San Diego, Calif., manufacturing facility have landed the healthcare management company a warning letter.

Establishing the right kind of verification process and bringing in human factor testing experts early are key to successful device design, says industry consultant Michael Hoffman.