Digital information has taken over our day-to-day lives, and the federal Food and Drug Administration (FDA) continues to recognize that this includes many aspects of our health care as well. This is clearly demonstrated by the set of initiatives established by the FDA that will directly impact how new, disruptive, and innovative products and services, like digital medical devices, are regulated. To do so, the FDA has created the Software Precertification Pilot Program to accelerate and streamline the regulatory approval process.

Beginning with the 21st Century Cures Act, the federal government sought to accelerate medical device product development and regulatory approval in order to provide new, innovative devices to in-need patients. First and foremost, the 21st Century Cures Act amended the legal definition of a medical device to exclude “health software” that is generally defined as software not used to treat, mitigate or cure a disease or actively monitor patients. Examples are administrative software, records-keeping software, and general reference software. Life Sciences Decoded covered the FDA’s Mobile Medical Device guidance two years ago, and the new act very much mirrors the FDA’s application of similar considerations to hardware that the act is now applying to software. In other words, the FDA is not going to regulate low-risk software that is meant to assist in administrative operations but will, instead, focus on those devices and software applications that are directly involved in patient treatment.

After the passing of the 21st Century Cures Act, the FDA has created its Digital Health initiative, the purpose of which is to focus the FDA Center for Devices and Radiological Health (CDRH) on increasing its efficiency in the regulation of the medical device industry as it relates to:

  • Health IT
  • Telemedicine
  • Medical Device Interoperability
  • Software as a Medical Device (SaMD)
  • General Wellness
  • Cybersecurity

As part of the Digital Health initiative, the FDA has recognized that the traditional regulatory schemes addressing medical devices are not well-suited to regulate the ever-changing, often updated and regularly patched nature of software as these regulations are historically hardware-focused. As a result, the FDA has created a pilot program called the “Digital Health Software Precertification Program,” or PreCert. The Software PreCert Pilot Program is a voluntary program that the FDA hopes will develop a software-focused process rather than focusing solely on hardware.

The FDA’s stated goals of its Digital Health Initiative and the PreCert Pilot are to:

  • Enable a modern and tailored approach that allows software iterations and changes to occur in a timely fashion within a known regulatory system;
  • Ensure high-quality medical product software throughout the life of the product by enabling companies to demonstrate an embedded culture of quality and organization excellence (CQOE); and
  • Be a program that can adapt over time based on the effectiveness of the program and feedback from the industry.

Companies wishing to participate can submit a statement of interest at FDAPre-CertPilot@fda.hhs.gov. These statements have specific requirements, and the Life Sciences team would be happy to help you draft a statement for your company. The FDA began accepting submissions on Aug. 1, 2017, and the program will begin on Sept. 1, 2017. Furthermore, the FDA is taking comments on the new program from members of the industry. Comments may be submitted here, and the Life Sciences Decoded team would be happy to assist your company in drafting a comment that will effectively convey your concerns or suggestions.