FDA Tries to Clarify Regulation of Health Software

Postado Dezembro 08, 2017

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. "Examples include knee replacements and implants created to fit like a missing puzzle piece into a patient's skull for facial reconstruction", Gottlieb said. Explore 3D printing technologies across the show floor, and learn about the technology through tours, activities, demos and conference sessions during the three-day event on February 6 to 8, 2018.

3-D printing is even advancing the field of regulatory science, and Gottlieb said FDA has 3-D printing facilities on its campus for agency scientists and engineers to use.

The first of the two draft guidances outlines approaches to clinical and patient decision support software (so-called CDS and PDS), defining which types aren't defined as a medical device and wouldn't be regulated by the agency.

"Such answers could, for example, help improve the effectiveness and comfort of prosthetic devices", Gottlieb said. "This research also helps inform us, as regulators, to help us understand the policy framework needed to ensure the quality and safety of 3D printed products". Guidance includes FDA thinking on approaches to 3D printing such as device design, functional testing of products, durability of products and quality system requirements. Overall, it will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure FDA's regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology, said Gottlieb's statement.

However, Gottlieb stresses that the guidance is only initial thoughts about the emerging technology and FDA recommendations could evolve in unexpected ways.

Gottlieb added that FDA is working to establish a regulatory framework for how it plans to apply existing laws and regulations that govern device manufacturing to non-traditional manufacturers like medical facilities and academic institutions that create 3D-printed personalized devices for specific patients they are treating.

"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.

FDA also plans to review the regulatory issues related to bioprinting in the recently released regulatory framework on regenerative medicine. "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. "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". But the FDA is now preparing for a significant wave of new technologies that are almost certain to transform medical practice.