Clinic Manufacturing Provider Screening 
Alabama Academy of Family Physicians
MAY 15, 2025
Bill Easing Volunteer Rules for Retired Physicians Awaits Governor’s Signature What’s in the Bill: HB 346 streamlines volunteer opportunities for retired physicians at free health clinics is headed to the Governor for final approval. HB 45 – Medicaid Coverage for Cologuard Test What’s in the Bill: Sponsored by Rep.
Imperial Center Family Medicine
JUNE 2, 2025
Your digestive system doesn’t just process food; it also influences cholesterol screening levels in your bloodstream. The liver manufactures new cholesterol molecules and captures excess from circulation for excretion. Specific strains and enzymatic factors influence efficiency.
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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. 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.
FDA Law Blog
NOVEMBER 20, 2024
Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.
FDA Law Blog
SEPTEMBER 29, 2023
For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers. These LDTs are performed in clinical laboratories regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This proposed rule is a long-time coming.
FDA Law Blog
AUGUST 23, 2022
The 80% sensitivity requirement for antigen tests has yet to be explained either scientifically or clinically by the Agency. After two negative tests, you should consider a molecular test, or call your healthcare provider. It is clearly rooted in fear that less sensitive tests may have too many false negatives.
FDA Law Blog
OCTOBER 10, 2023
airport security screening), or surgical procedures, as well as the potential for reoperation or revision of the implant. Testing should be in line with the device’s intended duration of implantation, but FDA may consider whether testing results for a shorter duration can be extrapolated to provide information about long-term performance.
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