CDRH-2023-118641 DIDSR2023-33705 - Glass Pathology Slides of Cancer

Closed Solicitation Posted

Solicitation number
FDA-RFQ-CDRH-2023-118641
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Silver Spring, Maryland 20903, United States

Notice details come from SAM.gov. Updated .

Notice text

This RFQ replaces any previous RFQ posted relating to this requirement. Please, respond per attached RFQ posted on SAM.gov. Interested vendor should follow the RFQ instructions and submit a quote accordingly, by the due date. No reminders will be provided, nor will FDA accept late quotes. Also not the following feedback from industry.

Note****. Our major issue is shipping out slides especially since many of the biopsies might have limited material. Would you be willing to receive Whole-slide images; we use the Aperio GT450 as our standard workhorse scanner; and could provide scanned images (and primary and secondary metadata).

Response:[BDG:]  Slides are shipped all the time in pathology. If you have limited material on the slides, there will be limited material on the images. We don’t feel you have described a legitimate issue. Furthermore, the Aperio GT450 is not an FDA cleared device, and the images would have limited value in a validation data set to be used for regulatory purposes. We will consider this offer in comparison to other offers.

RFQ does not have any follow-up clinical data?  Would that be of any interest?

Response: [BDG:] No. We have identified the metadata that we want, and it does not include follow-up clinical outcomes.

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