FDA Law Blog
SEPTEMBER 16, 2024
FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. This would include continuous manufacturing, distributed manufacturing, modern aseptic manufacturing equipment and novel analytical methods.
The Medical Futurist
JUNE 21, 2025
Treating less serious ailments gets faster, more targeted and more efficient, while the means for curing more serious and life-altering illnesses improve. Researchers say that the implant cannot provide any highly detailed vision – but it can help patients detect distinct patterns such as door frames and shapes.
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FDA Law Blog
NOVEMBER 1, 2023
Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.
My Green Doctor
MAY 3, 2025
The breadth of services provided by modern day medicine is profound. Video recordings were taken as providers administered perioperative routine eyedrops to patients and the eye drop bottle tips were cultured to assess microbial growth. The product manufacturers and vendors will need to be active partners as well.
FDA Law Blog
OCTOBER 25, 2021
The regulatory uncertainty has ill?befitted In the PMA context, the statute permits FDA to withhold approval if manufacturing facilities do not conform to QSR requirements. FDA says inspections may be necessary if a device has “critical and/or novel manufacturing processes that may impact the safety and effectiveness of the device.”
FDA Law Blog
JUNE 12, 2023
As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee. They have inspectors in the field everyday with eyes on the products, on the local manufactures, and on the distributors and retailers.
CDOCS
APRIL 14, 2021
& But, I don’t know if anything has done as much for bringing CAD/CAM into general dentistry offices more than the ability to manufacture zirconia restorations chairside.</span></p> .& I would wager that anyone that has used the Primescan would never give it back for their Omnicam or Bluecam.&
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