How Are Digital Therapeutics
|_||Digital therapeutics are most commonly regulated under the Software as a Medical Device (SaMD) framework. This framework was developed by the International Medical Device Regulators Forum (IMDRF), and often serves as the guide for the development and implementation of country-specific DTx-related regulations.|
Regulatory Best Practices
Digital therapeutics are categorized based on the level of risk associated with each product’s claim. Best practices all digital therapeutics should adhere to include:
- Be compliant with oversight provided by each national regulatory agency or notified body, including review of safety and efficacy medical claims.
- Register with the applicable regulatory agency or notified body in each jurisdiction the product is being used.
- Be compliant with regional manufacturing requirements.
- Ensure that product claims are appropriate to clinical validation, regulatory status, and marketing authorization.
- Adhere to labeling and advertising regulations under appropriate authorities, including all labels and other written, printed, or graphic matter accompanying or associated with the product.
Food and Drug Administration (United States)
- Guidances with Digital Health Content
- Software as a Medical Device (SaMD)
- Digital Health Innovation Action Plan
- Digital Health Software Precertification (Pre-Cert) Program
Medicines and Healthcare Products Regulatory Agency (United Kingdom)
- Medical devices regulations: compliance and enforcement
- Medical devices: software applications (apps)