Regulate

A well-defined regulatory strategy is critical to the success of your technology and is closely connected with the innovation’s intended use and pathway to market. Once you have identified the risk level for your concept, you will be able to establish risk management procedures to identify, analyze, and mitigate potential challenges with your technology.

Considerations

  • Learn about regulation by researching guidance resources from regulatory bodies.
  • Add entries about the process you take to regulate the technology to your development documentation.
  • Understand the distinction between class I, II, and III medical devices, , as well as technologies that are not classified as medical devices.
  • Work with a regulatory expert to assess your technology. This assessment will help you understand important regulatory information, such as your risk level, your product codes for all desired markets, and what kind of testing you will need.
  • If your concept collects, creates, or shares consumer information, work with an expert to determine how you will ensure protection of this information under HIPAA or PHIPA.
  • If you are planning to sell your concept internationally, work with a regulatory expert to determine any unique requirements.
  • Determine how much money you will need to complete your regulatory plan and how you will fund it.

Resources

Federal Trade Commission: Developing a Mobile Health App?

The U.S. Federal Trade Commission provides information laws that apply to digital health innovations.

FDA Center for Devices and Radiological Health

The U.S. FDA provides education on medical device and radiation-emitting product regulations, covering both premarket and postmarket topics.

FDA: Classify your Medical Device

The U.S. FDA provides information on three regulatory classes that determine clearance to bring a concept to market based on the level of control necessary to ensure safety and effectiveness.

FDA: Classify Your Medical Device

The U.S. FDA provides information on three regulatory classes that determine clearance to bring a concept to market based on the level of control necessary to ensure safety and effectiveness.

FDA: Digital Health

The U.S. FDA provides information on laws and guidance documents that impact digital health innovations.

Health Canada: Medical Device Regulation

Health Canada provides information on how medical devices are approved and authorized in Canada.

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

This document provides an overview of how to request feedback from the U.S. FDA regarding potential or planned medical device applications and submissions.

Use of Real-world Evidence to Support Regulatory Decision Making for Medical Devices

This document clarifies how the U.S. FDA evaluates real-world data to determine whether they are sufficient for generating the types of real-world evidence that can be used in regulatory decision making for medical devices.

Fast Forward Medical Innovation: Commercialization of Life Science Technologies

Fast Forward Medical Innovation provides information to help biomedical researchers accelerate their innovations from idea to impact. This presentation highlights medical device development, U.S. Food and Drug Administration (FDA) regulation, intellectual property, mentorship opportunities, and funding resources.

MaRS Library

The MaRS Library contains articles, templates, reports, workbooks, reference guides, and videos that cover a range of topics, including medical technology regulation.