k.janecek2022-08-26T09:16:03+00:00February 8th, 2022|Categories: Compliance, FDA, Regulatory, USA|Tags: 510K, Compliance, FDA, medicines, MedTech, Regulatory Affairs, USA|
US: The FDA has finalized guidance on the use of premarket pathways for combination products The FDA has finalized guidance on the use of premarket pathways for combination products. The document defines combination products, the coordination between the [...]
adminMTE_04792022-10-06T10:52:22+00:00November 4th, 2021|Categories: Various|Tags: 510K, BLA, denovo, Device Software, FDA, HDE, IDE, Medical Devices, PMA, SaMD, SiMD|
Content of Premarket Submission for Device Software Functions FDA issued a draft guidance that identifies the software information generally necessary for evaluating the safety and effectiveness of a device in a premarket submission. This document is intended to cover: ▪️ [...]
Elena Trombettoni2022-10-06T12:42:38+00:00September 30th, 2021|Categories: Digital Health, FDA, Innovation, Software|Tags: 510K, eSubmission, FDA|
Electronic Submission Template for Medical Device 510(k) Submissions On September 28th, FDA published draft Guidance on the ''Electronic Submission Template for medical device 510k Submissions'', which will remain open for public consultation for 60 days. The Guidance introduces [...]
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