EMERGO SUMMARY OF KEY POINTS:

• The US FDA will begin its Pre-Certification for Software (Pre-Cert) pilot program for digital health technologies considered medical devices in September 2017.
• Eligibility requirements for Pre-Cert participation as well as frequently asked questions have been published.
• As of now, US regulators have not set a deadline for applying to participate in the Pre-Cert program.

Following the rollout of a pre-certification pilot program for digital health technology and software developers, the US Food and Drug Administration has identified and answered several frequently asked questions regarding participation.

The FDA’s new FAQ covers key aspects of the agency’s new Pre-Cert for Software pilot program, intended to allow access for qualifying digital health product developers to the US market without extensive premarket review.

Pertinent deadlines for Pre-Cert participation

US regulators opened the Pre-Cert program to voluntary participants starting August 1, 2017, and plan to begin the program on September 1, 2017; nine participants will be accepted, according to the FAQ. Interested companies may apply electronically or via written submissions to the FDA.

Pre-Cert prerequisites

The FDA has listed several eligibility requirements for companies interested in participating in the pilot, including:

• Applicant must be developing or planning to develop a software product that falls under the US Federal Food, Drug, and Cosmetic Act’s definition of a medical device
• Applicant must already have a track record of developing, testing and maintaining software according to proper quality controls and use of Key Performance Indicators (KPI)
• Applicant must be willing to provide access to KPIs and related measures, post-market performance data and information about its quality management system
• Applicant must be available for consultations with and on-site visits from FDA staff

Key questions regarding Pre-Cert pilot participation

According to the FDA FAQ, digital health software developers should bear in mind the following issues when considering whether to apply for participation in the Pre-Cert pilot:

• Exactly how much time will be required to participate in the pilot depends on an individual firm’s size and the characteristics of its technology or product; however, the FDA does not anticipate a “multiyear commitment.”
• Pre-Cert participation is open to foreign companies, as well as to companies whose products have not yet undergone FDA medical device premarket review.
• Companies whose products are already undergoing pre-510(k) or Pre-Submission with the FDA may also apply to participate in the Pre-Cert pilot, but should not interrupt their standard US market authorization efforts.
• Class I and II medical devices exempt from 510(k) premarket notification requirements are also eligible to participate in the Pre-Cert pilot.
• The Pre-Cert pilot is slated to begin September 1, 2017,but there is no deadline for submitting applications to participate.

Additional US FDA regulatory resources and services:

• Regulatory consulting support for digital health technology companies
• US FDA 510(k) premarket notification consulting services
• Whitepaper: Wearables versus FDA regulated medical devices
• Whitepaper: Does your mobile medical app require FDA clearance?