FDA attempts to ease regulatory burden on software developers

Maricruz Casares
Diciembre 8, 2017

The agency claimed December 4 to be the world's first to provide a comprehensive technical framework to advise manufacturers creating medical products on 3D printers.

One final guidance and two draft guidances are part of the FDA's mission to address digital health products as dictated by provisions of the 21st Century Cures Act, FDA Commissioner Scott Gottlieb, MD, said in a statement.

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".

The agency said it reviewed more than 100 3-D printed devices now on the market, including devices tailored to fit a patient's anatomy. For example, there are knee replacements and implants created to fit like a missing puzzle piece into a patient's skull for facial reconstruction. 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", he said.

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"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. The Center for Drug Evaluation and Research's (CDER) facility enables FDA scientists to conduct research to determine how the 3D printing of drugs impacts inactive ingredients and other drug components as well as the quality control process of manufacturing.

"We envision that burn patients in the near future will be treated with their own new skin cells that are 3D printed directly onto their burn wounds", according to Gottlieb. Such answers could, for example, help improve the effectiveness and comfort of prosthetic devices.

FDA published "Technical Considerations for Additive Manufactured Medical Devices", a guidance document for industry and the FDA staff, on Dec.5 and said it is the world's first agency to provide a comprehensive technical framework to advise manufacturers creating medical products on 3D printers. "We stand at an inflection point in medicine". Guidance includes FDA thinking on approaches to 3D printing such as device design, functional testing of products, durability of products and quality system requirements.

"These steps are part of our broader effort to help ensure our regulatory framework is properly matched to the unique attributes of the new technologies we're being asked to review", said Gottlieb. The agency clarifies that "mobile apps that are intended only for maintaining or encouraging a healthy lifestyle" fall outside of its oversight because they are low-risk with potential for great benefit.

"We are already seeing the beginning of this evolution as hospitals and academic centers use their own 3-D printers to create innovative dental implants, replacement knee joints, and experimental heart valves and bone implants for use in clinical studies", he 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.

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