The FDA recently announced that the annual period for medical device establishment registration renewal has...

The medical device regulators of Australia, Brazil, Canada and the US have all signed on to a statement of cooperation to develop a single audit program for medical devices to be used by all four market authorities. Upon implementation of the MDSAP program, the audit of a medical device manufacturer’s quality system in any one of the four participating countries will meet regulatory requirements of all four countries—a significant move that could ease medical device company’s paths to market in these regions.

There are important changes coming soon from the US FDA that may affect your company...

The US Food and Drug Administration has published a list of frequently asked questions regarding

It’s not just the US Food and Drug Administration mulling over how to regulate mobile medical applications these days. The US Federal Trade Commission (FTC) has also recently come out with guidelines for medical app developers targeting advertising and privacy issues. The FTC recommendations cover basic legal requirements that medical app manufacturers must meet in order to market their products, introducing obligations for these companies to be met along with FDA medical device registration requirements.

The US Government Accountability Office (GAO) has issued recommendations that the Food and Drug Administration develop a comprehensive plan to improve the agency’s ability to review and monitor active implantable medical devices that rely on wireless and other advanced technologies.

The US Food and Drug Administration has published guidance outlining its plans for requiring medical device manufacturers to submit registration materials electronically via the agency’s eCopy Program. The eCopy Program is currently voluntary, but will become mandatory upon finalization of the proposed guidance as required by the Food and Drug Administration Safety and Innovation Act signed into law earlier in 2012. Once mandatory, the program will require manufacturers to submit eCopies along with standard application documents in order for the FDA to process and review them. Applications that do not include eCopies of their submissions will be put on hold until applicants provide eCopies.

The US Food and Drug Administration has set new review timeframes and performance goals for 510(k) premarket notification reviews of medical devices following Congressional approval of the Medical Device User Fee Amendments of 2012 (MDUFA III) earlier this year. By 2017, the agency intends to reduce the average total time for 510(k) decisions to 124 days from 150 days for fiscal year 2012.

The US Food and Drug Administration has published a new report showing small but consistent...

New guidance published by the US Food and Drug Administration advises manufacturers of “home use” medical devices on how to ensure compliance with safety and effectiveness requirements when designing their products.