Regulatory Focus™ > News Articles > FDA Updates on Digital Health Plans, Software Pre-Certification Pilot

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Posted 27 July 2017 | By Michael Mezher 

FDA Updates on Digital Health Plans, Software Pre-Certification Pilot


The US Food and Drug Administration (FDA) on Thursday released new details on its plans for regulating digital health technologies, including more information about its upcoming pilot program to pre-certify software-based medical devices.

According to the agency's newly released Digital Health Innovation Action Plan, FDA's Center for Devices and Radiological Health (CDRH) plans to improve the landscape for digital health technologies by developing guidance on the medical software provisions of the 21st Century Cures Act, strengthening its recently announced digital health unit and by piloting the software pre-certification program.

Pre-Certification Pilot

The pilot, first announced by FDA Commissioner Scott Gottlieb in June, will look to shake up the agency's traditional product-based approach to reviews by instead assessing developers based on their software development, validation and maintenance practices.

"The goal of our new approach is for FDA to, after reviewing systems for software design, validation and maintenance, determine whether the company meets the necessary quality standards and pre-certify the company," Gottlieb said in a blog post on Thursday.

Developers that meet those standards could, Gottlieb said, submit less information to the agency than would normally be required for marketing.

For certain low-risk devices, Gottlieb imagines companies could forego a premarket submission altogether.

"In those cases, the pre-certified company could launch a new product immediately and begin postmarket data collection [after] demonstrating that the underlying software and internal processes are sufficiently reliable," Gottlieb said.

Figure 1. FDA's Proposed Precertification ProcessPreCert

FDA says it plans to select up to nine companies representing a broad spectrum of software developers to participate in the voluntary program beginning on 1 September 2017.

FDA also says it plans to host a webinar on 1 August 2017 to provide additional information about the pilot, and will begin accepting applications to the pilot on that date.

In January, Gottlieb says FDA will host a public wor

kshop to present the initial results of the pilot to other developers.

Planned Guidance

As part of its digital health efforts, FDA says it plans to issue draft guidance on Cures provisions for mobile medical apps, medical device data systems, medical image storage and communications devices, low-risk general wellness products and laboratory workflow by the end of 2017.

The agency also says it plans to issue draft guidance on its approach to reviewing products with software functions that both fall under its over oversight and functions that do not in Q1 2018 and draft guidance on clinical decision support software in Q2 of that year.

FDAVoice, Federal Register Notice, Digital Health Innovation Action Plan


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