The Advanced Medical Technology Association (AdvaMed) has responded to the FDA’s recent Digital Health Innovation Action Plan, commending the initiative for its new regulatory approach to medical device software.
Action Plan
In response to the Action Plan, AdvaMed has released a list of tenets that it believes will help the FDA refine its digital health regulations.
The Digital Health Innovation Action Plan outlines the FDA’s approach to regulating digital health products in a timely and efficient manner.
Besides from making sure the FDA has the right policies in place for various technologies, the Plan also includes a pre-certification program that can help reduce market burdens for software developers.
AdvaMed, alongside the Medical Imaging Technology Alliance (MITA) have listed a number of tenets that they believe will help the Digital Health Innovation Action Plan. The outcome for the Plan, it states should be to help:
- Revamp the premarket submission process for SaMD and SiMD so that it is based on the safety risk of the technology and the manufacturer’s demonstration of a commitment to quality and patient safety, while also reducing documentation requirements.
- Allow for software changes to occur in an expedited fashion while ensuring that potential user risks due to such changes are appropriately mitigated.
- Streamline post-market surveillance requirements
- Reduce FDA’s own administrative burdens associated with these technologies to focus resources on other critical initiatives.
Earlier this year AdvaMed responded to the FDA’s Digital Health Innovation Action Plan, with Janet Trunzo, senior executive vice president, technology and regulatory affairs, saying:
“AdvaMed applauds the release of FDA’s digital health innovation action plan and announcement of a pilot for a pre-certification program. AdvaMed Digital Health has been deeply engaged with FDA on the development of the pre-certification program and looks forward to continuing to work on this exciting opportunity. We believe the pre-certification program, if properly implemented, has the potential to reduce pre- and post-market burdens for both software developers and FDA, and enable streamlined changes and modifications to software.
“AdvaMed also commends FDA for its commitment to release guidance concerning implementation of the 21st Century Cures Act, clinical decision support, and devices with multiple functionalities, and final guidance on software modifications. However, we continue to have concerns with the International Medical Device Regulators Forum (IMDRF) clinical evaluation document on software as a medical device (SaMD), which is based on a classification scheme that does not align with FDA’s statutory framework, and do not believe it should be issued as a final guidance by the agency.
“It is essential that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable efficient development of these technologies. We look forward to continuing to work with FDA and Commissioner Scott Gottlieb to expand patient access to advanced digital health technologies that empower consumers and improve patients’ lives.”
