Devices & Diagnostics Letter

The FDA has compiled a checklist for agency staff and industry to use in determining whether a 510(k) submission is adequate and ready for review, as part of the agency’s move from a 30-day to a 15-day time-to-acceptance decision.

The FDA Thursday ordered St. Jude Medical to conduct three-year postmarket surveillance studies of its troubled Riata and Riata ST coronary leads to obtain data on the likelihood of premature insulation failure.

Telemetry firm ScottCare has corrected all violations found during a site inspection earlier this year, earning an Aug. 13 close out letter from the FDA’s Cincinnati District Office.

If the FDA follows the recommendations of two Democratic lawmakers, 510(k) databases could soon include more information about recalls and other safety problems.

A plan to have CDRH’s Office of Device Evaluation (ODE) review 30-day notices of manufacturing changes, rather than the Office of Compliance, will first be piloted in the cardiovascular devices division, D&DL has learned.

A new Democratic bill that would require more sponsors to publicly register and report results of clinical trials draws attention to NIH’s failure to release proposed rules on the U.S. trials database following the site’s expansion five years ago under the FDA Amendments Act (FDAAA).

In a victory for the biotechnology industry, the U.S. Court of Appeals for the Federal Circuit ruled 2–1 to reaffirm its earlier ruling that Myriad Genetics can patent genes related to its breast and ovarian cancer screening system.

Devicemakers in Canada will now have to pay a fee to renew their establishment licenses annually by April 1, or face cancellation and enforcement actions, according to an updated Health Canada guidance.

China’s State Food and Drug Administration (SFDA) has wrapped up a public consultation on the reclassification of 745 in vitro diagnostic (IVD) reagents as part of an effort to develop a more sophisticated device classification system.

A bevy of documentation shortcomings led to a warning letter for Compumedics Germany. The company makes Doppler ultrasonic imaging diagnostic systems.

A bracelet that recognizes patients by bioimpedance and wrist size could one day provide a route to interoperability for mobile health (mHealth) devices, recent research suggests.