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| HHS/FDA | RIN: 0910-AF86 | Publication ID: Spring 2008 |
| Title: Medical Device Reporting; Electronic Submission Requirements | |
| Abstract: The Food and Drug Administration (FDA) is proposing to amend its postmarket medical device reporting regulations to require that reports submitted to the Agency by persons subject to mandatory reporting requirements be transmitted electronically in a form that FDA can process, review, and archive. FDA is taking this action to improve the Agency’s systems for collecting and analyzing postmarketing safety reports. The proposed change would help the Agency to more quickly review safety reports and identify emerging public health issues. In addition, the proposed rule proposes to implement quarterly manufacturer malfunction summary reporting for certain devices as required by the Food and Drug Administration Amendments Act of 2007. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed 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 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
| Federalism: Undetermined | |
| Included in the Regulatory Plan: Yes | |
| RIN Data Printed in the FR: No | |
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Agency Contact: Nancy Pirt Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-6248 Fax:301 847-8145 Email: nancy.pirt@fda.hhs.gov |
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