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FDA releases long-awaited clinical decision support guidance, clarifies oversight of mobile apps

08 Décembre 2017

The agency hasn't seen as much developmet of these tools yet, according to FDA Commissioner Scott Gottlieb, and he attributed that in part to "regulatory ambiguity".

Additionally, it said, "The FDA would like to bring to the attention of institutions dealing in medical devices that donation of medical devices are regulated by the FDA under the Public Health Act, 2012, Act 851".

He said the agency has reviewed more than 100 devices now on the market that were manufactured on 3D printers, such as knee replacements and implants created to fit into a patient's skull for facial reconstruction. "Examples include knee replacements and implants created to fit like a missing puzzle piece into a patient's skull for facial reconstruction", Gottlieb said. FDA also approved the first drug produced on a 3D printer, which is used to treat seizures, that is more porous and dissolves faster in the mouth than legacy products.

"This is likely just the tip of the iceberg given the exponential growth of innovative research in this field", he said.

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One of the draft guidances, the 13-page "Clinical and Patient Decision Support Software", outlines which types of clinical decision support software (CDS), which can compare patient-specific signs with available clinical guidelines to recommend treatments, would no longer be defined as a medical device, and thus would not be regulated. "We envision that burn patients in the near future will be treated with their own new skin cells that are 3-D printed directly onto their burn wounds". "Further down the road, there is potential for the same technology to eventually be used to develop replacement organs".

"We're also helping to advance the field of regulatory science with state-of-the-art 3D-printing facilities located on the FDA's campus", said Gottlieb in his statement. FDA engineers in the Center for Devices and Radiological Health (CDRH) have been conducting research using their own 3D printing facility to investigate the effect of design changes on the safety and performance of devices, and to determine how iterative changes alter the device's fit and functionality.

"Such answers could, for example, help improve the effectiveness and comfort of prosthetic devices", Gottlieb said. Guidance includes FDA thinking on approaches to 3D printing such as device design, functional testing of products, durability of products and quality system requirements.

The technical guidance is only meant to provide FDA's initial thoughts on the emerging technology, and Gottlieb said the agency's recommendations are likely to evolve as the technology does. "An increasing number of surgeons across the country have been saving infants born with a life-threatening breathing condition by creating patient-matched 3D-printed splints to install in their patients' tiny airways, which expand and degrade as the babies grow". "Regulation of medical devices is primarily to ensure that they are safe, meet the required standard, and perform as specified in the indications for use", it said. The agency also plans to review the regulatory issues related to the bioprinting of biological, cellular, and tissue-based products to determine if additional guidance is needed beyond the recently released regulatory framework on regenerative medicine medical products.

FDA releases long-awaited clinical decision support guidance, clarifies oversight of mobile apps