Events Manufacturing Patients Screening 
FDA Law
OCTOBER 10, 2023
airport security screening), or surgical procedures, as well as the potential for reoperation or revision of the implant. Performance data should be customized to the indications for use, including the specific intended patient population (adult vs. pediatric), disease state, conditions of use, and the target anatomical location.
GeriPal
MAY 5, 2022
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. How to screen for hearing loss. On today’s podcast, we talk to Nick Reed and Meg Wallhagen about hearing loss in geriatrics and palliative care.
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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
And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. And that’s a good thing to share with an older patient or client that making decisions about your activity.
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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