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The FDA has published draft guidance outlining an ethical framework for involving children in clinical trials of drugs and devices, as well as trial design considerations. Read More
Reauthorization of FDA’s user fee legislation moved ahead a step last week as leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee agreed to include a slimmed-down version of user fee legislation and smaller policy riders on a short-term government funding bill, or continuing resolution (CR). Read More
The FDA needs to revise its Emergency Use Authorization (EUA) policies for tests of future infectious disease outbreaks, the HHS Office of Inspector General recommends in a new report. Read More
The EU’s surveillance system for legacy in vitro devices must remain in place during the transition to the new In Vitro Diagnostic Regulation (IVDR), according to the Medical Device Coordination Group (MDCG) of the European Medicines Agency. Read More
The FDA and the National Institutes of Health have teamed up to fund small businesses that create innovative medical device development tools (MDDT), such as biomarker tests, clinician- and patient-reported outcome measures, nonclinical assessment models and digital health technologies. Read More
The FDA will require electronic submission of 510(k) applications by Oct. 1, 2023, according to a final guidance that provides standards for using the agency’s electronic Submission Template and Resource (eSTAR) portal. Read More
Boston Scientific’s Sentinel cerebral protection system did not meet the primary endpoint in a large randomized trial since “the data demonstrated a non-significant trend towards a lower rate of stroke in patients treated with the Sentinel device,” the company said in a presentation at the Transcatheter Cardiovascular Therapeutics annual scientific symposium in Boston, Mass. Read More
An FDA inspection of Stuart, Fla.-based Powers Medical Devices found that the company had not been doing internal audits, according to a Form 483 the agency issued to the company. Read More
Insulin and intrathecal pain pumps, intracardiac defibrillators, mobile cardiac telemetry and pacemakers are among the devices “susceptible to cyber attacks,” according to a new FBI statement that cites a recent healthcare cybersecurity analyst’s report. Read More
Carryover funds and an undisclosed contingency plan will keep the FDA’s user fee program in motion even if Congress misses the Sept. 30 deadline for reauthorizing the Medical Device User Fee Amendment (MDUFA V), said FDA’s Jeff Shuren at the recent annual meeting of the Regulatory Affairs Professionals Society (RAPS) in Phoenix. Read More