mdi ConsultantsFDA wants your comments!! Your chance to be heard!!!!!
FDA announced an opportunity for public comment on the guidance document for Design Considerations and premarket Submission Recommendations for Interoperable Medical Devices. In today’s world where technology plays an important role, the Medical Device industry is bringing in new technologies in market. The Healthcare industry is increasingly connecting the existing medical devices to each other and with other updated technologies which offers the potential to increase the efficiency in patient care.
The Objective of the draft Guidance of January 26, 2016 is to promote the development and availability of interoperable devices. The FDA wants to lay down a road map for the development and design of interoperable devices and recommendation for content of premarket submission and labeling. To ensure the proper, safe and effective exchange and use of information between the device and technology is utmost important.
For your voice to be heard and your comments to be considered, submit either electronic or written comments on the draft guidance by March 28, 2016. Submit electronic comments to regulations.gov. Submit Written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 The Written Comments should include the Docket No. FDA-2015-D-4852 for “Design Consideration and Pre-market Submission Recommendation for interoperable Devices” If you wish to submit any confidential information that you do not wish to be made publicly available submit written comments only, with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.”
? For any assistance or questions or clarification please contact us at [email protected] or use our Contact form. Ref: Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices.