Safe Medical Device Reporting Act

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Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

The Medical Device Reporting (MDR) regulation ( 21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related...

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

eCFR :: 21 CFR Part 803 -- Medical Device Reporting

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803

If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, …

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 report …

CLINICAL POLICY Reporting Adverse Medical …

https://health.uconn.edu/policies/wp-content/uploads/sites/28/2021/07/Reporting-Adverse-Medical-Device-Incidents-11-032.pdf

In compliance with the Safe Medical Devices Act of 1990 (Act) it is the policy of John Dempsey Hospital to report to the Food and Drug Administration (FDA) or the device …

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) to …

Medical Device Reporting: Electronic Submission …

https://www.federalregister.gov/documents/2014/02/14/2014-03279/medical-device-reporting-electronic-submission-requirements

The Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629) amended the FD&C Act to require mandatory reporting of device adverse events by user facilities …

Medical Device Reporting - ecri.org

https://www.ecri.org/search-results/member-preview/hrc/pages/medicaldevicereporting/

Medical device reporting (MDR) is intended to help the U.S. Food and Drug Administration (FDA) identify medical device problems that pose a threat to public health …

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 and …

U-M Hospitals and Health Centers - Association for …

https://www.aami.org/docs/default-source/uploadedfiles/filedownloads/htm/idea-exchange/ei-safedeviceact.pdf

The Safe Medical Device Act Policy is intended to integrate with existing UMHHC policies and procedures involving medical device related incidents and to comply with the …

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