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HHS/FDA | RIN: 0910-AF86 | Publication ID: Spring 2013 |
Title: Medical Device Reporting; Electronic Submission Requirements | |
Abstract: FDA is amending its postmarketing medical device reporting (MDR) regulations to require manufacturers and importers to submit electronic reports of individual medical device adverse events to the agency. Electronic submission of MDRs will improve the agency's systems for collecting and analyzing postmarket MDRs. This change is expected to result in significant burden reductions in reporting and recordkeeping for reporting entities. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 803 | |
Legal Authority: 21 USC 352 21 USC 360 21 USC 360i 21 USC 360j 21 USC 371 21 USC 374 |
Legal Deadline:
None |
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Timetable:
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Additional Information: Includes Retrospective Review under E.O. 13563. | |
Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Madhusoodana Nambiar Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, WO 66, Room 5518, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-5837 Fax:301 847-8145 Email: madhusoodana.nambiar@fda.hhs.gov |