Devices & Diagnostics Letter

Delivering on her promise to promote regulatory science to help devicemakers get their products to market faster, FDA Commissioner Margaret Hamburg has announced plans for an Office of Science and Innovation.

Devicemakers are taking CDRH to task over suggested changes they say could fundamentally alter the 510(k) clearance program or exceed the agency’s authority.

An agreement between the FDA and the Pan American Health Organization (PAHO) could enhance harmonization among regulatory authorities in the Americas, speed response times to problems in the medical supply chain and make doing business in Latin America less complicated for devicemakers.

In their rush to gain market share, devicemakers may be launching 510(k) devices without addressing some safety concerns, a CDRH official says in explaining an increase in Class I recalls.

Tougher enforcement, pediatric devices and global supply chain issues are among the FDA’s top priorities for the next five years as the agency seeks to advance initiatives implemented since Margaret Hamburg became commissioner.

Devicemakers addressing humanitarian needs might be eligible for a fast-track patent re-examination voucher under a pilot program proposed by the PTO.

Wright Medical Technology will pay $7.9 million and enter into a deferred prosecution agreement (DPA) to end a criminal investigation into its consulting arrangements with orthopedic surgeons.

Synthes and its subsidiary Norian will pay more than $23 million to resolve felony and misdeameanor charges relating to unapproved clinical trials of bone-cement products that resulted in three deaths.

As the growing use of imaging and radiation devices continues to grab headlines and regulatory attention, the imaging industry is focusing on distinguishing appropriate uses of the technology.

Devicemakers have a new tool to help them find suitable vendors — a CDRH database that provides information about device inspections from 2008 to the present.

A lack of device master records for its motorized scooters resulted in a warning letter for Amigo Mobility International.

The FDA is “months away” from releasing a new guidance to provide a clear scientific pathway for nanotechnology-based devices.

The FDA is initiating a national survey to determine whether consumers adequately understand the benefits and risks associated with devices and drugs.