Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Device Interoperability: US FDA Details Expectations In Final Guidance

Executive Summary

Electronic interface functionality, data-exchange factors and time synchronization are among key interoperability factors for device-makers to consider in device design and pre-market submissions, US FDA says in a final guidance document. The guidance stresses the need for developers to consider potential risks of interoperability from device conception and throughout the lifecycle.

You may also be interested in...

Global Medtech Guidance Tracker: August 2017

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirteen new guidance documents were posted to the tracker in August.

Additions To Interoperability Guidance Proposed By FDA Reviewer In Likely Internal Agency Recommendation

An FDA reviewer has proposed two recommendations to FDA's recent interoperability guidance that would require a letter outlining cooperation between manufacturers whose products interact and how to simultaneously submit 510(k) applications for products where changes can affect interoperability of multiple devices. Reviewer Ian Broverman's comments, however, may not have been meant for public consumption and was likely meant to be an internal FDA recommendation.

FDA Emphasizes Risk Analysis, Labeling Details In Interoperability Draft Guidance

For manufacturers designing devices intended to be interoperable with other systems, FDA spelled out its premarket expectations for proper risk analyses, verification and validation studies, and suggested labeling in a Jan. 25 draft guidance.

Related Content





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts