Zdrowie i gospodarka · 23.02.2016
Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period
The Food and Drug Administration (FDA or Agency) is extending the comment period provided in the notice entitled "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability" that appeared in the Federal Register of January 26, 2016. That notice announced the availability of a draft guidance for industry and FDA staff and requested comments by March 28, 2016. FDA is extending the draft guidance's comment period by 30 days in response to requests for an extension to allow interested persons additional time to submit comments.