k.janecek2023-03-29T14:06:37+00:00February 8th, 2022|Categories: Compliance, FDA, Regulatory, USA|Tags: 510K, Compliance, FDA, medicines, MedTech, Regulatory Affairs, USA|
The FDA has finalized guidance on the use of premarket pathways for combination products. The document defines combination products, the coordination between the FDA and sponsors, and recommendations on how to determine the types of premarket submissions for a [...]
adminMTE_04792023-03-29T15:49:17+00:00November 4th, 2021|Categories: Various|Tags: 510K, BLA, denovo, Device Software, FDA, HDE, IDE, Medical Devices, PMA, SaMD, SiMD|
FDA issued a draft guidance that identifies the software information generally necessary for evaluating the safety and effectiveness of a device in a premarket submission.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: ▪️ firmware and other means for software-based control of medical [...]
Elena Trombettoni2024-02-02T10:49:34+00:00September 30th, 2021|Categories: Digital Health, FDA, Innovation, Software|Tags: 510K, eSubmission, FDA|
On September 28th, FDA published draft Guidance on the ''Electronic Submission Template for medical device 510k Submissions'', which will remain open for public consultation for 60 days.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 the electronic Submission Template and Resource tool eSTAR, which [...]
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