Clinic Electronics Manufacturing Screening 
The Medical Futurist
JUNE 21, 2025
The 80-year-old Ray Flynn lost his central vision entirely, but with the help of the retinal implant, he could make out shapes on the computer screen. Experts even say the eye is an ideal place to start for the first clinical use of CRISPR. Google is not the only one working on A.I. solutions for eye care, though.
FDA Law Blog
NOVEMBER 20, 2024
Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that simulated use/leachables studies to simulate the clinical use (i.e., In the draft guidance, FDA illustrates the need for additional orthogonal data (i.e.,
FDA Law Blog
JULY 7, 2024
Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.
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