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| HHS/FDA | RIN: 0910-AF86 | Publication ID: Fall 2007 |
| 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. | |
| 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 (To search for a specific CFR, visit the Code of Federal Regulations.) | |
| 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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Statement of Need: The proposed rule would require user facilities and medical device manufacturers and importers to send medical device adverse event reports electronically 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 electronically 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 electronic submission of this information. 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 100,000 medical device reports currently submitted in 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 $8.9 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 | |
| RIN Data Printed in the FR: No | |
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Agency Contact: Myrna Hanna Regulations Staff Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health (HFZ-215), 1350 Piccard Drive, PI50 RM150F, Rockville, MD 20850 Phone:240 276-2347 Fax:240 276-2352 Email: myrna.hanna@fda.hhs.gov |
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