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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
Overview of the Safe Medical Devices Act of 1990
- https://www.drugwatch.com/fda/safe-medical-device-act/
- The Safe Medical Devices Act of 1990 was a critical step in the FDA’s longtime efforts to monitor the impact of faulty medical devices on public health. ... D.K. …
H.R.3095 - Safe Medical Devices Act of 1990 - Congress
- https://www.congress.gov/bill/101st-congress/house-bill/3095
- Shown Here: Conference report filed in House (10/26/1990) Safe Medical Devices Act of 1990 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to require medical …
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 …
Safe Medical Devices Act: Impact on a hospital-based …
- https://journals.sagepub.com/doi/abs/10.1177/108482239400700110
- The Safe Medical Devices Act (SMDA) was signed by President George Bush on November 28, 1990, and the Federal Drug Administration's (FDA's) final ruling …
H.R.3095 - Safe Medical Devices Act of 1990 - Congress
- https://www.congress.gov/bill/101st-congress/house-bill/3095/text
- Text for H.R.3095 - 101st Congress (1989-1990): Safe Medical Devices Act of 1990
A History of Medical Device Regulation and Oversight in …
- https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states
- In the 1960s and 1970s, Congress responded to the public’s desire for more oversight over medical devices by passing the Medical Device Amendments to the Federal Food, …
Safe Medical Devices Act of 1990: current hospital …
- https://pubmed.ncbi.nlm.nih.gov/10132639/
- 1993 Sep;1-34. Author H Alder 1 Affiliation 1 H.C. Alder & Associates, Palatine, IL. PMID: 10132639 Abstract Since the Safe Medical Devices Act of 1990 was signed into law, a …
Safe Medical Device Act Definition | Arena
- https://www.arenasolutions.com/resources/glossary/safe-medical-device-act/
- The Safe Medical Devices Act (SMDA) of 1990 is a federal law that requires medical device manufacturers and user facilities (i.e., hospitals and ambulatory surgical facilities) …
Safe Medical Devices Act: Reporting Requirements and …
- https://www.omic.com/safe-medical-devices-act-reporting-requirements-and-risk-management-concerns/
- A new law mandating the reporting of injuries resulting from defective medical devices is generating concern among ophthalmologists, risk managers and others that the reports …
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