The U.S. FDA has finally unveiled the fifth edition of the device user fee program (MDUFA V), and some of the performance measures remain unchanged from MDUFA IV, such as that the FDA will process 95% of 510(k) filings within 90 days.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has undertaken a massive effort to reform its drug and device regulations, and as it pulls into the homestretch with those reforms, it is setting its sights to postmarketing efforts that include adverse event reporting, conformity assessments, patient-reported outcomes and a universal device identifier program.
Entities that lack experience in FDA regulation of medical devices may find the going both expensive and time consuming, but there are resources available to these players in the digital health space. Bakul Patel, director of the Digital Health Center of Excellence at the FDA’s device center, said that while he understands that reading through agency guidance is an unpleasant task, the companies that take the time to do so may find their interactions with the agency less iterative and more productive, thus speeding their path to market.
The med-tech regulatory picture is already in a state of flux thanks to changes imposed by the EU, but device makers and those in the digital health space might soon be facing yet another series of profound changes in Europe. The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) has proposed to revamp its regulatory framework for both traditional medical device and for software/artificial intelligence, adding yet more uncertainty to an already turbulent European regulatory environment.
There are few guidelines of any sort that are specific to artificial intelligence (AI) for medical devices, but that doesn’t mean there are no signposts for developers. There are existing product marketing authorizations that offer some insights, but the FDA’s Bakul Patel said a risk stratification guidance by the International Medical Device Regulators Forum (IMDF) is an example of a non-AI blueprint for how the FDA will ultimately approach regulation of AI.
The FDA’s May 2021 draft guidance for post-approval studies for PMA devices did not present any regulatory novelties, but did propose tighter timelines for filing, reviewing and fulfilling post-approval study (PAS) protocols. However, a review of the agency’s PAS database suggests that both the agency and industry might have a difficult time complying with the proposed new standards for turnaround times for these studies.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Shuren, Stenzel push back on serology tests; FDA touts accomplishments for 2020; IMDRF posts five-year plan.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIST ramps up Zero Trust cybersecurity program; TGA sets date for mesh up-classification; IMDRF posts post-market study update; ANVISA updates list of non-regulated devices.
The annual med-tech conference hosted by the Advanced Medical Technology Association, always features an FDA town hall, but this year’s town hall labored under the overhang of the COVID-19 pandemic. Nonetheless, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), repeatedly gave voice to frustration with the statutory authorities currently enjoyed by the center, stating on more than one occasion that the Medical Device Amendments of 1976 are more than 40 years old and are in need of updates to cope with modern medical technology.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking industry feedback on further strengthening reforms for adverse events and postmarket regulations for medical devices.