Devices & Diagnostics Letter

Medical device industry reps and FDA officials negotiating the next user fee authorization are behind schedule and want to accelerate their progress, but those meetings remain acrimonious and the parties are still far apart on major issues.

The FDA proposes to streamline device clinical trials in a pair of draft guidances outlining requirements for early feasibility studies and explaining when a trial can begin even when there are outstanding issues with an Investigational Device Exemption (IDE) submission.

The FDA has released a standard operating procedure (SOP) on when reviewers working with 510(k) and PMAs can ask additional questions.

As of Nov. 1, Health Canada requires makers of Class III and IV devices and in vitro diagnostics (IVDs) to submit all premarket review documents both electronically and on paper, according to a recent guidance.

The regulatory status of pre-amendment cranial electro-stimulators (CES) remains in doubt.

A Lantheus Medical Imaging exhibit panel promoting an imaging diagnostic is misleading because the display fails to disclose radiation overdose risks and makes unsubstantiated claims that the product is superior to competitors, according to an FDA untitled letter.

The Securities and Exchange Commission (SEC) should allow a three-year grace period for devicemakers and other U.S. companies to comply with a mandate that companies disclose use of “conflict minerals” mined in Central Africa, AdvaMed says.

Stability is returning to the orthopedic device market after a period of pressure to reduce prices, companies told analysts at the North American Spine Society annual conference.

FDA device review needs revamping, a bipartisan group of House and Senate members said in a letter to Commissioner Margaret Hamburg.

The third quarter of 2011 saw 290 recalls involving nearly 30 million units of device and diagnostic products, consultants with ExpertRECALL, an industry recall consultancy, said.

Zimmer displayed slack design validation on a pair of hip implants, according to a Form 483.

Devicemakers must show, through risk analysis and risk management, that animal tissues or derivatives used to produce devices are safe and clinically beneficial and lack suitable alternatives, according to a recent draft regulation by the European Commission.

Per regulatory procedure, the European Commission (EC) is investigating Johnson and Johnson’s (J&J) proposed acquisition of Synthes.

Device-related adverse events rose 13 percent to 10,280 in the UK during 2010, according to the Medicines and Healthcare Regulatory products Agency (MHRA).