The Medical Futurist
JUNE 21, 2025
Large language models will soon find their way in to everyday clinical settings , simply because the global shortage of healthcare personnel is becoming dire and AI will lend a hand with tasks that do not require skilled medical professionals. Current medical AIs only process one type of data, for example, text or X-ray images.
FDA Law Blog
SEPTEMBER 22, 2024
MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCF : LDT, unmet need within an integrated healthcare system. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule.
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The Medical Futurist
JUNE 21, 2025
While it is really difficult to manufacture a contact lens, which is one-third of a millimetre in diameter, a 3D printer sandwiches together different layers of interacting material, which makes it easier to match tiny pieces.
FDA Law Blog
JANUARY 5, 2023
The Playbook is a guide for healthcare delivery organizations to respond to cybersecurity incidents that threaten device function and, potentially, patient safety. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. FDA has shown a willingness to intervene in this space.
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 test articles represent the worst-case manufacturing process, and provide the examples that the device undergoes the greatest number of sterilization and/or reprocessing cycles.
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.
FDA Law Blog
MAY 21, 2024
Public comments must be submitted electronically or postmarked on or before July 22, 2024, 60 days after publication in the Federal Register. Findings The CSA requires analysis of eight statutory factors for scheduling, rescheduling, or descheduling substances of abuse. 21 U.S.C. §
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