Regulatory Strategy

The definition of product use-cases, functionality, and expected customer benefits all have major regulatory implications to project costs and schedules. Our team continuously monitors relevant medical device guidance from regulators in the USA, EU, and China.

We have assisted clients in attaining ISO 13485 certification, a CE Mark for a software medical device, NMPA approval for a software medical device in China, and supported submission of 510(k) applications to the FDA. We help clients balance AI technology possibilities with regulatory realities.

Clinical Validation Study Design
Most medical image analysis applications used for triage, detection, and diagnostic support are Class II medical devices and cannot be promoted or otherwise marketed before regulatory approval is granted. The time and level of effort required to gain regulatory clearance or approval of such devices often exceed the technical efforts that it took to build the device. These generally require formal studies that comply with official regulations and published guidance documents. The research protocol documents the evaluation approach, data collection strategy, sampling design, and addresses human subjects’ regulatory concerns. The Clinical Validation Plan includes an updated regulatory strategy based on the predicate landscape that exists at the time of the study.
Regulatory Pathway Analysis
Bringing solutions to the market requires early preparation and a clear understanding of the regulatory landscape. To help you market your application, we review appropriate predicate devices that could influence the regulatory pathway for software medical devices. This includes reviewing FDA 510(k) submissions for which premarket approval is not required, and for the de novo pathway in which the effectiveness of a new solution must be proven.
Regulatory Submission
For clients interested in bringing their solutions to the market, we can assist in preparing regulatory packages for submission to regulatory agencies in the United States, European Union, and China. After submitting regulatory forms, device documents, and study results, we support organizations in their interactions with regulatory agencies and notified bodies.

Recommended Resources

FDA Quality System Regulation

The U.S. Code of Federal Regulations (CRF) defines the quality system requirements for medical devices. Regulations are subject to change based on new laws and the ongoing regulatory process. To get the most current version, visit the Electronic Code of Federal Regulations, select Title 21, then select the range beginning with 800.

FDA Software Pre-Certification Program

The US Food & Drug Administration Digital Health Software Pre-Certification (Pre-Cert) Pilot Program will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices.

Design Controls

Quality System Regulations for medical software developers are listed under the provision of Subpart C-Design Controls (820.30). Compliance with Design Controls is a pre-condition for submitting applications for FDA clearance or approval. These controls are specified in the regulation, but the processes used to comply with them can be tailored to each device manufacturer. 

International Medical Device Regulators Forum

The International Medical Device Regulators Forum (IMRDF) is a voluntary group of medical device regulators from around the world that discuss future directions in medical device regulatory harmonization. In October 2015, the IMRDF published Software as a Medical Device (SaMD): Application of Quality Management System that defines SaMD lifecycle support, realization, and use processes.

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