FDA releases 3 policies on digital health oversight

The second draft guidance outlines FDA's interpretation of which types of software are no longer considered medical devices.

In a statement signed by Mrs Delese A.A. Darko, the Chief Executive Officer of the FDA, and copied to the Ghana News Agency, the FDA stated that medical devices were regulated as part of the mandate of the Food and Drugs Authority (FDA) as specified in Part 7 of the Public Health Act, 2012, Act 851.

To date, FDA has reviewed more than 100 devices now on the market that were manufactured on 3D printers, including patient-matched devices tailored to fit a patient's anatomy. "Examples include knee replacements and implants created to fit like a missing puzzle piece into a patient's skull for facial reconstruction", Gottlieb said. This drug, which dissolves more rapidly in the mouth to work faster, is used to treat seizures. "This is likely just the tip of the iceberg given the exponential growth of innovative research in this field". "We are already seeing the beginning of this evolution as hospitals and academic centers use their own 3D printers to create innovative dental implants, replace knee joints, and [produce] experimental heart valves and bone implants for use in clinical studies". "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". 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. "We stand at an inflection point in medicine".

The FDA's new guidance says that when physicians can independently review the basis of recommendations made by CDS software, that software no longer constitutes a covered medical device.

"It includes our thinking on various approaches to 3-D printing, including device design, testing of products for function and durability, and quality system requirements", Gottlieb said.

The draft also proposes to not enforce regulatory requirements for lower-risk decision support software meant to be used by patients or caregivers, including software that reminds a patient how or when to take a prescribed drug. The Center for Biologics Evaluation and Research has recently interacted with more than a half-dozen manufacturers who have expressed interest in using 3D printing in some capacity to produce their medical products. "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". 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.