PERTH, Australia – It was already going to be a busy year for Australia’s Therapeutic Goods Administration (TGA) as it planned to implement the final wave of device reforms in 2020 before the COVID-19 pandemic hit. The delay to the EU Medical Device Regulation (MDR) as a result of the pandemic will mean that Australia will also push back many of its device reforms for another year, said John Skerritt, the TGA’s deputy secretary of the Health Products Regulation Group.
The news that the U.S. FDA has opened a new digital health office carries some significant expectations for stakeholders, expectations that may take time to meet. More than one participant in the Oct. 19 FDA listening session for the Digital Health Center of Excellence (DHCoE) called on the FDA to ensure that this new center provides more regulatory clarity regarding a number of products, a task that may be some time in coming, given the need to harmonize with other national and international regulatory entities.
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 – A review by Australia’s Therapeutic Goods Administration (TGA) revealed that medical device recall databases may significantly under-represent software errors, causing harm to patients. These under-reported events are due to patients being unaware how to report problems, inadequate information being reported, effects of software errors being too subtle or difficult to detect, or root cause analyses that may not identify software as the source of error when it causes other components to fail.
The comment period has closed on the U.S. FDA’s discussion draft for artificial intelligence (AI) in medical devices, a paper that attracted the attention of medical societies and regulated industry. One of the questions posed by industry was whether the FDA is in a position to deal with the massive volumes of data developers would have to disclose to the agency, creating concern that such disclosures would amount to little more than an obligatory and useless data dump.
The implementation date for the EU’s new med-tech regulatory framework has been pushed back a year, giving device makers much-needed breathing room for compliance work. At the same time, the International Organization for Standardization (ISO) has not fulfilled the planned May update of its device clinical investigations standard, ISO 14155.
Developers of artificial intelligence (AI) algorithms have their own nightmares to deal with, but the FDA is charged with employing a regulatory touch that steers clear of rocky shoals on one side and inescapable whirlpools on the other. The FDA’s Bakul Patel said during a Feb. 25 workshop that the FDA would quickly be swamped if the agency took a traditional regulatory approach to managing the super-iterative digital health space, but that the agency will keep a keen eye on the potential impact on patients as AI begins to move into clinical practice.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has issued a draft guidance to help sponsors better understand the evidence requirements for market authorizations for medical devices, including in vitro diagnostics (IVDs) and software as a medical device (SaMD).
Australia's Therapeutic Goods Administration (TGA) recently posted a draft guidance for regulation of software as a medical device, but the Medical Technology Association of Australia expressed a preference for an international standard for risk classification.
PERTH, Australia – It's likely that Australia will not draft separate guidance or regulations for software applications that use artificial intelligence or machine learning (AI/ML) for drug development or medical devices. Instead, the Therapeutic Goods Administration (TGA) will classify AI and ML under software as a medical device (SaMD) when it is intended for diagnosis, prevention, monitoring or treatment or alleviation of disease.