National Technical Reports Library

The National Technical Information Service acquires, indexes, abstracts, and archives the largest collection of U.S. government-sponsored technical reports in existence. The NTRL offers online, free and open access to these authenticated government technical reports. Technical reports and documents in its repository may be available online for free either from the issuing federal agency, the U.S. Government Publishing Office’s Federal Digital System website, or through search engines.

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Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992.

PB93128767

Publication Date	1992
Page Count	32
Abstract	The booklet updates a previous Center for Devices and Radiological Health publication. Highlights of the Safe Medical Devices Act of 1990 (Public Law 101-629). The Safe Medical Devices Act of 1990 (SMDA), which became effective on November 26, 1990, gave the Food and Drug Administration (FDA) several new authorities and expanded and modified previous medical device requirements. After the Highlights booklet was published, Congress enacted the Medical Device Amendments of 1992 (the 1992 Amendments), which changed some of the provisions of SMDA. The revised booklet reflects the requirements of both statutes. The booklet addresses SMDA's new enforcement authorities for FDA, among which are the reporting of medical device problems to FDA by user groups and distributors. It also describes changes in device classification and reclassification, changes that affect the premarket notification and premarket approval processes, and changes that affect the good manufacturing practices requirements. It gives the effective dates of the new provisions and also lists Federal Register documents that apply to SMDA.
Keywords	Medical equipment Medical legislation Documentation Distributing Penalties Design Performance standards Safe Medical Devices Act of 1990 Medical Device Amendments of 1992 Product recall Product safety Postmarket surveillance Device tracking Premarket approval
Source Agency	Center for Devices and Radiological Health
NTIS Subject Category	95C - Biomedical Instrumentation & Bioengineering 44H - Health Care Technology
Corporate Authors	Food and Drug Administration, Rockville, MD. Center for Devices and Radiological Health.
Supplemental Notes	Supersedes PB92-109370.
Document Type	Technical Report
NTIS Issue Number	199308

Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992.

Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992.
PB93128767

Publication Date	1992
Page Count	32
Abstract	The booklet updates a previous Center for Devices and Radiological Health publication. Highlights of the Safe Medical Devices Act of 1990 (Public Law 101-629). The Safe Medical Devices Act of 1990 (SMDA), which became effective on November 26, 1990, gave the Food and Drug Administration (FDA) several new authorities and expanded and modified previous medical device requirements. After the Highlights booklet was published, Congress enacted the Medical Device Amendments of 1992 (the 1992 Amendments), which changed some of the provisions of SMDA. The revised booklet reflects the requirements of both statutes. The booklet addresses SMDA's new enforcement authorities for FDA, among which are the reporting of medical device problems to FDA by user groups and distributors. It also describes changes in device classification and reclassification, changes that affect the premarket notification and premarket approval processes, and changes that affect the good manufacturing practices requirements. It gives the effective dates of the new provisions and also lists Federal Register documents that apply to SMDA.
Keywords	Medical equipment Medical legislation Documentation Distributing Penalties Design Performance standards Safe Medical Devices Act of 1990 Medical Device Amendments of 1992 Product recall Product safety Postmarket surveillance Device tracking Premarket approval
Source Agency	Center for Devices and Radiological Health
NTIS Subject Category	95C - Biomedical Instrumentation & Bioengineering 44H - Health Care Technology
Corporate Authors	Food and Drug Administration, Rockville, MD. Center for Devices and Radiological Health.
Supplemental Notes	Supersedes PB92-109370.
Document Type	Technical Report
NTIS Issue Number	199308