Multiple function device products are medical products that have at least one device function (medical) and one non-device function (non-medical) or other function. Among these, some are subjected to FDA’s Regulatory oversight as medical devices, while others are not. Hence, FDA issued a final guidance addressing the review of medical products that contain both, the medical and the non-medical functions.
As an update to a draft that was issued in April 2018, the new guidance specifies how and when the FDA will assess the impact of “other functions” of a product that are not evaluated in a pre-market review. This guidance intends to identify the principles, pre-market review practices, and policies for FDA’s Regulatory assessment of such products. Previously, the 21st Century Cures Act excluded certain software functions from being considered as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Also, the Cures Act states that when a product with multiple functions has both the software non-device function and a device function, the FDA may assess on how the non-device function impacts the device function, while assessing the safety and effectiveness of the device function. FDA intends to implement a similar kind of assessment for all the multiple function device products.
Pre-market Review Policy
In general, the non-device software functions of products will not be regulated by FDA. However, the agency may assess the other function’s impact on the device function/s, if the other function impacts device function of the product. As per the existing policies, FDA intends not to review a device function subjected to an enforcement discretion policy, merely because it is part of a multiple function device product. Stating an example for the multiple function device products, FDA points out to skin cancer detection software application, which has both the device function (detects skin cancer – under review) and other function (smartphone computing platform and camera). Here, FDA does not regulate a general-purpose computing platform but may assess its impact on the safety and effectiveness of a device function under review. FDA believes in applying the same principles for assessing all the multiple function device products, irrespective of software- or hardware-based functions, or both.
Regarding the risk assessment process, manufacturers should determine if the other function impact the safety and effectiveness of the device function that is under review. The impact can be negative, positive or both, including, slow computing time affecting the performance of the device function under review and a processing speed, which could enhance the device function. Although FDA does not recommend submitting information about all positive impacts from “other functions” in a pre-market submission, all impact assessments (negative, positive, and no impact) must be performed and documented as a part of design validation.
The pre-market review can be done under one of the following Regulatory frameworks:
- 510(k) pre-market notification
- De Novo classification request (a special approach to be applied in case of entirely new medical devices)
- Biological License Application (BLA) that covers certain devices
- Investigational Device Exemption (IDE), or
- Humanitarian Device Exemption (HDE)
As the FDA states, pre-market submission for a device function under review must include:
- Indications for Use
- Device Description (Description of Functions)
- Architecture and Design
- Device Hazard Analysis
- Requirements and Specifications
- Performance Testing
- Submission Summary
In a nutshell, aforementioned information describes the FDA’s Regulatory approach for multiple function device products, while reviewing the pre-market submissions. Assessing these regulations will be useful for manufacturers attempting to navigate through the rapidly evolving Regulatory landscape for multiple function device products. Surpass the market-entry bottlenecks with Regulatory experts’ assistance. Stay safe. Stay informed. Stay compliant.