FDA Law

NOVEMBER 6, 2023

RIEs will require the facility to accommodate the “use of teleconference, livestream video, and screen sharing of data and documents.” Significantly, FDA agrees that the RIEs may be conducted in lieu of an inspection.

Manufacturing 105

Manufacturing Clinic Utilities IT 105

FDA Law

SEPTEMBER 17, 2023

For example, device sponsors can request a meeting with an FDA review team by submitting a pre-submission to CDRH (see our recent blog on the minor updates to the Pre-Submission Guidance). If you are driving, stop at the vehicle screening facility and inform security that you are attending a meeting.

Screening 59

Screening Transportation Provider Electronics 59

FDA Law

JUNE 8, 2023

The pandemic also deeply impacted how industry and the government conduct their operations. A teleconference will be conducted by voice only with no projection of presentations or use of video/camera; a videoconference would involve sharing a screen so that a presentation can be viewed by all participants and/or involve the use of video.

Relationship 53

Relationship Government Screening Medical 53

FDA Law

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. In short, Voluntary Consensus Standards (VCS) are intended to be exactly what the name conveys – standards that are adopted by consensus and are not mandatory (not legal or regulatory requirements).

Provider 59

Provider Screening IT Government 59

FDA Law

NOVEMBER 18, 2021

A positive result, however, is treated as a screen. That is just another way of saying, however, that the rapid antigen tests are best positioned as a screening tool. These tests could have been a valuable screening tool for COVID during the past year or so. A follow up laboratory?run run molecular diagnostic (RT?PCR)

Screening 98

Screening Manufacturing Healthcare IT 98

GeriPal

APRIL 18, 2024

I remember walking through San Francisco Airport with Bob, we just happened to be there at similar times, and saying, “Eric and I are thinking about starting a blog.” ” Eric: What was it called again, Wachter’s World? At the Mayo clinic, for example, they’ve got a very robust hospital at home program.

Electronics 139

Electronics IT Patients Healthcare 139