FDA launches new pilot program for health related software development

August 1, 2017
The FDA in the past few months has provided details and timelines for its digital health efforts in the Digital Health Innovation Action Plan. One important piece of this plan is a new pilot program for software developers named the "Software Precertification (PreCert) Pilot Program."  The reason for the pilot program is that FDA’s traditional approach to moderate and higher-risk, hardware-based medical devices is not well suited for the faster and iterative design, development, and validation used for software products.

Developing tailored approach

The Software PreCert Pilot Program is a voluntary program that will enable us to develop a tailored approach toward regulating this technology by looking first at the software developer and/or digital health technology developer, rather than primarily at the product, which is what we currently do for more traditional medical devices. This pilot will help FDA establish the most appropriate criteria for standing up a firm-based precertification program for these new tools.

The goals of this program are to:

  • Anable a modern and tailored approach that allows software iterations and changes to occur in a timely fashion.
  • Ensure high quality medical product software throughout the life of the product by enabling companies to demonstrate their embedded culture of quality and organization excellence (CQOE).
  • Be a program that learns and adapts and can adjust key elements and measure based on the effectiveness of the program.

CDRH will hold a webinar on August 1, 2017 to provide additional information on this program and to answer stakeholder questions.

About the action plan

The Digital Health Innovation Action Plan outlines the FDA's efforts for a new approach in  order to assure that all Americans, including patients, consumers and other health care customers have timely access to high-quality, safe and effective digital health products.

The action plan lays out the CDRH’s vision for fostering digital health innovation, while continuing to protect and promote the public health, including:

  • Issuing guidance to provide clarity on the medical software provisions of the 21st Century Cures legislation;
  • Launching an innovative pilot precertification program to work with our customers to develop a new approach to digital health technology oversight (FDA Pre-Cert for Software);
  • Building FDA’s bench strength and expertise in CDRH’s digital health unit.

The action plan was announced in a June 15 blog post by Scott Gottlieb, M.D., Commissioner of the U.S. Food and Drug Administration. He unveiled that the FDA wants to create a broad innovation initiative, including a plan to focus on the agency’s regulatory role in digital health technology.

This initiative is part of a broader FDA effort to advance policies that promote and develop safe and effective medical technologies, Gottlieb writes in a blog post. By taking an efficient, risk-based approach to our regulation, FDA can promote health through the creation of more new and beneficial medical technologies.

“We can also help reduce the development costs for these innovations by making sure that our own policies and tools are modern and efficient, giving entrepreneurs more opportunities to develop products that can benefit people’s lives,’ Gottlieb wrote.