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HHS/FDA | RIN: 0910-AF86 | Publication ID: Fall 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 manufacturers, importers, and user facilities submit mandatory reports of medical device adverse events to the agency in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agencys 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. | |
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 |
Legal Deadline:
None |
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Statement of Need: The proposed rule would require user facilities and medical device manufacturers and importers to submit medical device adverse event reports in electronic format instead of using a paper form. FDA is taking this action to improve its adverse event reporting program by enabling it to more quickly receive and process these reports. |
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Summary of the Legal Basis: The Agency has legal authority under section 519 of the Federal Food, Drug, and Cosmetic Act to require adverse event reports. The proposed rule would require manufacturers, importers, and user facilities to change their procedures to send reports of medical device adverse events to FDA in electronic format instead of using a hard copy form. |
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Alternatives: The alternatives to this rulemaking include not updating the medical device reporting requirements and not requiring submission of this information in electronic format. For over 20 years, medical device manufacturers, importers, and user facilities have sent adverse event reports to FDA on paper forms. Processing paper forms is a time consuming and expensive process. FDA believes this rulemaking is the preferable alternative. |
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Anticipated Costs and Benefits: The principal benefit would be to public health because the increased speed in the processing and analysis of the more than 200,000 medical device reports currently submitted annually on paper. In addition, requiring electronic submission would reduce FDA annual operating costs by $1.25 million. The total one-time cost for modifying SOPs and establishing electronic submission capabilities is estimated to range from $58.6 million to $79.7 million. Annually recurring costs totaled $8.5 million and included maintenance of electronic submission capabilities, including renewing the electronic certificate, and for some firms the incremental cost to maintain high-speed internet access. |
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Risks: 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 | |
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. | |
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 |