Regulatory Accelerator

Regulatory Accelerator is an initiative featuring specific FDA resources that have been curated and presented to meet the information needs of digital health innovators. New innovators may find these resources especially helpful as they learn about the FDA’s processes for regulatory review and oversight of their medical device software. By using these resources, innovators may create higher quality and complete submissions, facilitate review, help speed time to market, and ultimately increase patients’ access to safe and effective devices.

The Regulatory Accelerator initiative helps to support efficiency and transparency for digital health innovators on the journey of bringing medical device software to market.

FDA Resource Index for Digital Health Device Innovators - Tools, engagement opportunities and guidance to help you through all phases of the total product lifecycle.

Resource Index for Innovators

The Resource Index for Digital Health Device Innovators provides a visual guide to a selection of FDA tools, engagement opportunities, and guidances available throughout the process of bringing medical device software to market. This guide uses terms that are familiar to innovators. It is intended to orient innovators to the device regulatory and compliance life cycle and the FDA resources and tools available.

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Early Orientation Meetings

As part of Interactive Review, early orientation meetings offer an opportunity for sponsors interested in engaging early with the FDA on marketing submissions that include medical device software. These optional meetings are intended to be an interactive review mechanism for sponsors to provide an overview and device demonstration to the FDA review team to facilitate an understanding of an innovative device under review.

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Medical Device Software Guidance Navigator

The Medical Device Software Guidance Navigator is a resource designed to assist innovators of medical device software with identifying relevant FDA guidance documents for their medical device software development and marketing submissions. This resource largely aligns to relevant sections of the electronic Submission Template And Resource (eSTAR) and provides a streamlined approach for innovators to identify guidances that may be applicable to their device across the development life cycle.

Contact Us

Have questions or feedback about the Regulatory Accelerator? Send us an email at digitalhealth@fda.hhs.gov.