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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   
Legal Authority: 21 USC 352    21 USC 360    21 USC 360i    21 USC 360j    21 USC 371    21 USC 374   
Legal Deadline:  None

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.

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.

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.

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.

Risks: None

Action Date FR Cite
NPRM  09/00/2008    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
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

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