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H.R.3095 - Safe Medical Devices Act of …
- https://www.congress.gov/bill/101st-congress/house-bill/3095
- Safe Medical Devices Act of 1990 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to require medical device user facilities to report to the Secretary of Health and Human Services, the manufacturer, or both whenever they believe there is a …
Safe Medical Devices Act: management guidance for …
- https://pubmed.ncbi.nlm.nih.gov/10129209/
- The Safe Medical Devices Act of 1990 (Public Law 101-629) was signed by President George Bush almost three years ago on November 28, 1990. The law expanded the …
Impact of the Safe Medical Devices Act on healthcare …
- https://pubmed.ncbi.nlm.nih.gov/10123341/
- The Safe Medical Devices Act (SMDA) of 1990 (Public Law 101-629) is a federal law that became effective November 28, 1991. The SMDA mandates all facilities that use medical …
Safe Medical Devices Act of 1990 and the Medical …
- https://ntrl.ntis.gov/NTRL/dashboard/searchResults/titleDetail/PB93128767.xhtml
- 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 …
H.R. 3095 (101 st ): Safe Medical Devices Act of 1990
- https://www.govtrack.us/congress/bills/101/hr3095
- Safe Medical Device Amendments of 1990 or Safe Medical Devices Act sanctioned progressive reporting and tracking rules for medical devices classified …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=3.1
- This regulation relates to agency management and organization and has two purposes. The first is to implement section 503 (g) of the act, as added by section 16 …
Safe Medical Device Amendments of 1990 - Wikipedia
- https://en.wikipedia.org/wiki/Safe_Medical_Device_Amendments_of_1990
- Safe Medical Device Amendments of 1990 or Safe Medical Devices Act sanctioned progressive reporting and tracking rules for medical devices classified by the Medical …
Regulatory Status of Disinfectants Used to Process …
- https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/guidance-industry-and-fda-regulatory-status-disinfectants-used-process-dialysate-delivery-systems
- Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their …
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