FDA Announces Guidance on Interoperable Medical Devices | Practical Law

FDA Announces Guidance on Interoperable Medical Devices | Practical Law

The FDA announced final guidance on designing interoperable medical devices.

FDA Announces Guidance on Interoperable Medical Devices

Practical Law Legal Update w-010-3968 (Approx. 2 pages)

FDA Announces Guidance on Interoperable Medical Devices

by Practical Law Life Sciences
Published on 19 Sep 2017USA (National/Federal)
The FDA announced final guidance on designing interoperable medical devices.
On September 6, 2017, the FDA finalized guidance entitled Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices; Guidance for Industry and Food and Drug Administration Staff. The guidance discusses considerations for developing a medical device to safely and effectively use and exchange information from other devices or systems.
The guidance includes how to:
  • Design interoperable medical devices.
  • Verify, validate, and implement risk management activities.
  • Describe functional, performance, and interface characteristics in product labeling.
The guidance also includes pre-market submission recommendations for devices that require premarket approval or clearance. Comments on this guidance can be submitted at any time.