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Medical Device Reporting Regulation History | FDA
- https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/medical-device-reporting-regulation-history
- Since December 13, 1984, the FDA Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. The Safe Medical Devices Act (SMDA) of 1990 provided FDA with two additional … See more
H.R.3095 - Safe Medical Devices Act of 1990 - Congress
- 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 …
H.R.3095 - Safe Medical Devices Act of 1990 - Congress
- https://www.congress.gov/bill/101st-congress/house-bill/3095/text
- H.R.3095 - Safe Medical Devices Act of 1990 101st Congress (1989-1990) Law Hide Overview Subject — Policy Area: Health View subjects Summary (2) Text (7) Actions (42) …
Overview of the Safe Medical Devices Act of 1990
- https://www.drugwatch.com/fda/safe-medical-device-act/
- Jan 31, 2023
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 …
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 …
Safe Medical Devices Act: Reporting Requirements and …
- https://www.omic.com/safe-medical-devices-act-reporting-requirements-and-risk-management-concerns/
- The Safe Medical Devices Act of 1990 (SMDA) (Public Law 102-629) requires ambulatory surgery centers, hospitals, outpatient diagnostic centers and other user facilities to …
Medical Device Safety | FDA - U.S. Food and Drug …
- https://www.fda.gov/medical-devices/medical-device-safety
- Medical Device Safety | FDA Medical Device Safety The FDA monitors reports of adverse events and other problems with medical devices and alerts health …
The Safe Medical Devices Act of 1990: Are Hospitals …
- https://journals.lww.com/jcejournal/Abstract/1991/01000/The_Safe_Medical_Devices_Act_of_1990__Are.11.aspx
- The Safe Medical Devices Act of 1990 Are Hospitals Ready to Deal with the FDA? Loob, William H. Author Information Journal of Clinical Engineering: January 1991 - Volume 16 - …
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