Clinic Electronics Manufacturing Patients 
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. ” M-LLM (Translating for Patient): “¿Puede señalar dónde le duele?”
FDA Law Blog
DECEMBER 12, 2022
If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. Manufacturers of software products should determine whether their software functions are excluded from the definition of a device. Clinical Decision Support Software.
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The Medical Futurist
JUNE 21, 2025
The California-based firm, Second Sight , the German company, Retina Implant AG, and the French venture, Pixium Vision were the forerunners of the field, developing implantable visual prosthetics to restore vision to patients who are blind as a result of the rare condition of retinitis pigmentosa.
FDA Law Blog
MARCH 8, 2023
By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.
FDA Law Blog
FEBRUARY 15, 2023
FDA is making these updates in part due to recognition that some of the records and reporting requirements are unnecessary to comply with the Electronic Product Radiation Control (EPRC) program (sections 532, 534(a)(1), and 537(b) of the FD&C Act (21 U.S.C. Thus, these regulations apply to a huge variety of products.
FDA Law Blog
NOVEMBER 20, 2024
Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.
FDA Law Blog
SEPTEMBER 11, 2023
This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. In a statement released at the time, CDRH Director Jeffrey Shuren, M.D., stated, “ We appreciate the IOM’s report on the 510(k) program.
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