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Sharan Murugan
- Mar 30, 2023
- 1 min
USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device
Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...
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Sharan Murugan
- Mar 30, 2023
- 2 min
USFDA MD Guidance: Cybersecurity-Refuse to Accept Policy for Cyber Devices & Related Systems
Earlier today (30 March 2023) USFDA's Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research...
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Sharan Murugan
- Mar 27, 2023
- 2 min
USFDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices
Today (27 March 2023) USFDA's Center for Devices and Radiological Health released final guidance on "General Considerations for Animal...
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Sharan Murugan
- Mar 27, 2023
- 1 min
UK MHRA: Guidance on Register Medical Devices to place on the Market
Earlier today (27 March 2023) UK's Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance on "Register...
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Sharan Murugan
- Mar 24, 2023
- 1 min
USFDA MD Guidance: Transition Plan for M.D Issued Emergency Use Authorizations Related to COVID-19
On 24 March 2023, USFDA's Center for Devices and Radiological Health released two final guidances on "Transition Plan for Medical Devices...
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