FDA Law

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law

MARCH 8, 2023

Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format.

Electronics 59

Electronics Manufacturing Provider Medical 59

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. But individuals who have hearing loss, there’s several problems. How to screen for hearing loss.

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

FDA Law

AUGUST 21, 2023

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. A recent state law failure-to-warn case in the SDNY makes that very point.

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

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