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FDA's Digital Health Precertification Program

fda-pre-certIn January 2019, the US Food and Drug Administration announced the launch of a new regulatory model based on its Digital Health Precertification Program. As the program’s test plan continues to be implemented over coming months, we review the basics of Pre-cert, and what it means for the digital healthcare industry.

In 2017, as part of their Digital Health Innovation Action Plan, FDA announced its Digital Precertification Program for Software as a Medical Device (SaMD) products. The pilot program, commonly referred to as Pre-cert, was initiated with the aim to streamline the approval process of low to moderate- risk medical technology products.

Started as an experimental model with 9 companies participating in the pilot phase, Pre-cert has now reached its next evolutionary step towards becoming the standard model for the regulatory oversight of lower-class Software as a Medical Device (SaMD) products.

Participants of the Pre-cert pilot:

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

The FDA’s new program aligns with the changing landscape in the development of healthcare technology. It is, in essence, the FDA’s strategy to adapt to both the convergence between lifestyle and medical products, and the growing use of Agile in the development of such products, both of which are defining trends in the medical device industry.

Related reading: MedTech Trends 2019: the Era of Digital & Data-driven Health

Once it is formalized for open participation, Pre-cert will be open to technology companies that are not traditionally considered MedTech developers. It helps the FDA adapt its regulatory activities to the frequent iterations of Agile (and DevOps) development strategies, while maintaining a focus on patient safety, product quality, and reliability.

How is Pre-cert different?

Pre-cert will be able to reduce the content that developers are required to submit to the agency, taking much of the headache out of the process of premarket approvals, while still guaranteeing product quality.

The way the Digital Health Precertification Program does that is through shifting the focus from the product to the organization. Specifically, the pilot program defined five excellence principles based on which product developers were assessed:

  • patient safety
  • product quality
  • clinical responsibility
  • cybersecurity responsibility
  • proactive culture.

With Pre-cert, the FDA focuses on the enterprise-wide quality system rather than the specific artifacts and processes used during the development of a certain medtech product. By enabling companies to demonstrate a culture of quality and overall organizational excellence, the program will greatly accelerate the certification of subsequent product functions (updates).

In fact, it is possible that Pre-cert will completely replace the need for pre-market submissions, enabling frequent iterations of pre-certified products – the very basis of the Agile and DevOps development methods increasingly popular in digital healthcare technology.

Watch our on-demand webinar: Intland Software’s Roundtable Discussion: Agile in Medical Technology

Overall, Pre-cert is a modern approach tailored to the needs of next-generation medtech innovators with great benefits for developers of SaMD products.

What does Pre-cert means for developers of medical technology?

The first step of the Pre-cert model is Excellence Appraisal, the assessment of the organizational excellence of a medical technology firm applying for Pre-cert. Therefore, the primary consequence they have to deal with is increased scrutiny on their organization-wide Quality Management System.

Related reading: Medical Devices Quality Management Systems and Changes in ISO 13485:2016

Simply ensuring traceability and logging audit trail reports to hand in at compliance audits will no longer be sufficient. Organizations in the program will have to build a robust quality system that both guarantees and provides transparency of the company’s quality culture, as well as product performance across the entire lifecycle of Software as a Medical Device.

Companies in the program will also be able to leverage the postmarket performance data of their products, and use this as proof to accelerate the certification of subsequent updates or new products. Essentially, Pre-cert might spawn a new breed of companies that are able to rapidly and frequently develop and put to market innovative products that are FDA-approved from the concept phase.

This could have far-reaching effects on the whole industry, prompting late adopters of an organization-wide quality mindset to implement an all-encompassing Quality Management System.

  

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