FDA Law

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.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

GeriPal

MAY 5, 2022

We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. Communication techniques we can use when talking to individuals with hearing loss. And one of the parts of that was actually doing physicals for the students and putting them in job placements.

IT 102

IT Screening Hospital Clinic 102

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.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. 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.

Healthcare 128

Healthcare IT Education Community 128