Devices & Diagnostics Letter

Devicemakers may have to wait several months longer to learn whether, or how, the FDA will implement a number of controversial suggestions for revamping the 510(k) process.

The U.S. appears to be losing its edge when it comes to its capacity to adapt to the changing nature of device innovation, according to a report that confirms devicemakers’ warnings about the impact of growing unpredictability at the FDA and shrinking investments.

The FDA is likely to see its rules and guidances come under increased scrutiny now that President Barack Obama has initiated an overhaul of the country’s federal regulations.

The U.S. healthcare industry will work more closely with its Chinese counterpart under an initiative launched to improve innovation of drugs and devices in both countries through public-private partnerships.

St. Jude Medical is paying $16 million to the Justice Department to settle allegations it paid kickbacks to physicians to implant its pacemakers and defibrillators.

HHS’ Office of Inspector General (OIG) is rejecting a request to investigate, for the third time, claims from CDRH scientists that they faced retaliation when they raised concerns about the approval of an imaging device.

Following an ambitious list of goals it set for itself in 2010, including the launch of transparency initiatives and 510k reform, CDRH’s strategic priorities for this year are modest, it says.

CDRH’s ombudsman received 171 complaints last year, a 29 percent increase from 2009.

A nonprofit foundation has launched its own registry to make it easier for patients to learn if their implanted devices have been recalled.

Boston Scientific has signed an agreement to purchase Atritech, the maker of a novel device to treat patients with atrial fibrillation (AF) and a risk for ischemic stroke.

Nearly two years after the FDA began the process of formally classifying 25 types of pre-amendment Class III devices, none has received a final classification.

MannKind has received a second complete response letter for its inhaled insulin Afrezza requesting two new clinical trials in what one analyst sees as further proof of the FDA’s unpredictability.

The Centers for Medicare & Medicaid Services (CMS) may be more interested in creating a parallel review for devices than the FDA, a former FDA official says.