February 23, 2018

The FDA Digital Health PreCertification Program

Laleh Hassibi

Vice President of Marketing

The US Food and Drug Administration (FDA) has announced a new program for digital health software developers as part of a larger effort to develop a new regulatory framework. For any company that designs and develops software that is considered a medical device, this is important news.

What is Software as a Medical Device (SaMD)?

The definition that the FDA uses to for SaMD is “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device,” which was written by the International Medical Device Regulators Forum.

The FDA’s approach for regulating medical devices and drugs can take years and involves clinical trials and a massive amount of data. It does not lend itself to regulating software, which usually follows an iterative design and development process, proving compliance through programs like HITRUST CSF certification.

However, digital health products offer the prospect of better health outcomes for patients, smoother workflows for clinicians, and many tools for managing population health and chronic disease. According to the FDA, there needs to be “a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical promise and the compressed cycle of product iterations.”

The Software Precertification Pilot Program

The Pre-Cert Pilot Program, the FDA’s initial attempt at forming a regulatory framework for digital health products, will take a radically different approach. Instead of regulating products, the FDA plans to regulate the companies that build the products.

An article published in MedCity News last year notes,

Regulators want to see that the developers of health software are adhering to the highest quality standards, and that the team is not cutting corners.”

One of the stated goals of the precertification pilot is to include both large and small organizations. The FDA wants to create a scalable program that makes precertification possible in an organization “with a culture of quality and organizational excellence, regardless of size.” Nine participants in the pilot program were announced in September of 2017.

More than 100 companies expressed interest in participating. The FDA chose the following nine:

  • Apple
  • Fitbit
  • Johnson & Johnson
  • Pear Therapeutics
  • Phosphorus
  • Roche
  • Samsung
  • Tidepool
  • Verily

Does Precertification Help or Hurt?

The idea is that a company that was precertified could bring products to market much faster, and in some cases, without submitting any paperwork — that is because, through the process of becoming precertified, the FDA would have already verified the company follows high quality standards. Once a product was on the market, the company would be required to collect and submit post-market data to the FDA.

All of this is still in the very early stages, though. The pilot program was launched in July 2017, and the FDA expects to have what they are calling “Version 0.1” ready by the end of this year, but they caution that they “then plan to test, validate, and iterate” the program.

Some people in the industry are skeptical and worry that the precertification program will actually end up increasing the regulatory burden that companies already face. The FDA says they aim “to develop a program that allows organizations to maintain the customized processes they already use,” and that the overall goal is for software companies to “spend minimal resources translating what they do to our regulatory framework.”

It’s a Beginning

The precertification program is a beginning. Digital health products have a role to play in the current transformation of healthcare. Value-based payments, population health, management of chronic disease, and other problems that are currently being addressed in a massive shift in thinking can all benefit from various digital health products.

Giving software developers and organizations the freedom to create products, while also ensuring quality standards are met, is a good first step.

tag Healthcare News Compliance


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