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FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law Blog

OCTOBER 10, 2023

In the case of 510(k) Implants indicated for use in pediatric patients, FDA recommends consulting two other guidance documents: Pediatrics Guidance and Extrapolation Guidance. We find that this information is noteworthy for manufacturers to consider. programming, monitoring, maintenance). separate patient labeling).

Manufacturing

Manufacturing Engineering Clinic Provider

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. Finally, FDA will hold a public workshop on meeting management. Notable Dates and Timelines – New MAPP published, by Dec.

Patient-Centered

Patient-Centered Manufacturing Clinic Provider

Primary Care Digest

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

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