Demonstrating a continued focus on information security, the Food and Drug Administration (FDA) published draft guidance on Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. As the title indicates, the draft guidance focuses on issues manufacturers should address in the development and design of medical devices prior to sale to consumers. This draft guidance comes on the heels of the FDA’s draft cybersecurity guidance for medical devices after they have entered the market.
For those unfamiliar with the term, “interoperability” generally refers to the interconnectivity of various products or systems. For purposes of the FDA’s guidance, interoperability means the ability of two or more products, technologies or systems to exchange information and to use the information that has been exchanged. The exchange of information includes transmission, reception or both, that may be accomplished by means of wires or wireless methods which on a local network, or through the internet. The use of exchanged information can include various purposes such as displaying, storing, interpreting, analyzing and automatically acting or controlling another product.
According to the FDA, as electronic medical devices are increasingly connected to each other and to other technology, the ability of these connected systems to safely and effectively exchange and use the information that has been exchanged becomes increasingly important. As such, the FDA intends to promote the development and availability of safe and effective interoperable medical devices. The FDA issued this draft guidance to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information.
The draft guidance focuses on five considerations for interoperable devices:
- the purpose of the electronic data interface;
- the anticipated users;
- risk management;
- verification and validation; and
- labeling considerations.
Importantly, the FDA’s guidance documents, including this draft guidance, do not establish legally enforceable responsibilities. The guidance includes suggestions or recommendations, as opposed to requirements. The FDA is accepting comments and suggestions regarding the draft guidance until March 28, 2016.