Clinic Events Manufacturing Screening 
GeriPal
MAY 5, 2022
Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? Screening for addressing hearing loss should be an integral part of what we do in geriatrics and palliative care, but it often is either a passing thought or completely ignored. I’m guessing not.
FDA Law
OCTOBER 10, 2023
airport security screening), or surgical procedures, as well as the potential for reoperation or revision of the implant. Non-Clinical Recommendations The draft guidance highlights non-clinical review areas that are generally relevant across 510(k) Implants and offers recommendations for performance data to include in a 510(k) submission.
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FDA Law
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.
GeriPal
DECEMBER 7, 2023
AlexSmithMD Additional links: JAMA paper on clinical research risks, climate change, and health Geriatric medicine in the era of climate change Health Care Without Harm: [link] Practice Green Health: [link] Global Consortium for Climate and Health Education: [link] Transcript Eric: Welcome to the GeriPal podcast.
FDA Law
NOVEMBER 8, 2022
Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF). In closing, he advised manufacturers who plan to market their products beyond the public health emergency to plan to submit marketing applications. Maisel also discussed disposition of already distributed devices.
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