FDA Law Blog

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). Once your request for an in-person or hybrid meeting is agreed upon, you are expected to provide a list of in-person and virtual attendees.

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FDA Law Blog

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.

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FDA Law Blog

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand.

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FDA Law Blog

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)

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