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Parent RIN:   0910-AA09
HHS/FDA RIN: 0910-AE01 Publication ID: Spring 1998 
Title: Assignment of Agency Component for Review of Premarket Applctns 
Abstract: The Safe Medical Devices Act of 1990 (SMDA), enacted November 28, 1990, was intended to assure that marketed devices are safe and effective, that FDA learns quickly of device problems, and that FDA has authority to remove defective devices from the market. The act directs or authorizes FDA to develop these regulations: Medical Device Reporting--These rules require healthcare facilities and distributors to report deaths and serious injuries/illnesses related to medical devices. Medical Device Tracking--This regulation requires manufacturers to track certain devices to the user. Classification of Transitional Devices--FDA issued a notice to require submission of adverse safety and effectiveness data on transitional devices. FDA will now propose to keep each transitional device in class III, or reclassify it in class I or II. Good Manufacturing Practices for Medical Devices--FDA has added preproduction design validation to the CGMP regulations. Exemption of Humanitarian Devices--The final rule establishes procedures for applications for certain premarket review exemptions for humanitarian devices. Summaries of Safety and Effectiveness for Premarket Notification--The final rule sets forth information to be included in summaries of substantial equivalence determinations. Recall of Medical Devices--A final rule sets forth procedures for using authority to order device recalls and notifications. Reports of Removal and Corrections--FDA finalized procedures for manufacturers to report to FDA health-related market removals and corrections of devices. Civil Money Penalties--A final rule established procedures for a hearing to which persons are entitled before the imposition of civil money penalties. Procedural Changes in Medical Device Regulations--This final rule revised existing regulations to conform with procedural changes mandated by the SMDA. Premarket Review of Combination Products--FDA published a final rule establishing procedures for determining which FDA center will review premarket approval applications for products that are a combination of a device and a drug or biologic. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 860    21 CFR 820    21 CFR 807    21 CFR 803    21 CFR 17    21 CFR 812    21 CFR 7    21 CFR 814    21 CFR 821    21 CFR 861    21 CFR 895   
Legal Authority: PL 101-629 Safe Medical Devices Act of 1990   
Legal Deadline:
Action Source Description Date
Final  Statutory  for Medical Device Tracking for Exemption of Humanitarian Devices, etc. for Classification of Transitional Devices Notice for Medical Device Tracking  08/28/1993 
Final  Statutory  for Medical Device Tracking for Exemption of Humanitarian Devices, etc.  11/28/1991 
NPRM  Statutory  for Medical Device Tracking  08/28/1991 
Other  Statutory  for Medical Device Tracking for Exemption of Humanitarian Devices, etc. for Classification of Transitional Devices Notice  12/01/1991 
Timetable:
Action Date FR Cite
Notice (Public Hearing)  07/12/1991  56 FR 31951   
Final Action  11/21/1991  56 FR 31951   
Additional Information: Previously reported under RIN 0905-AD59.
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, Local, State 
Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations 
Included in the Regulatory Plan: No 
Agency Contact: