Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF JULY 08, 2023 SAM #7893
MODIFICATION

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

Notice Date

7/6/2023 8:21:16 AM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
 

ZIP Code

20705
 

Solicitation Number

FDA-RFQ-CDRH-2023-118641
 

Response Due

7/30/2023 9:00:00 AM
 

Archive Date

08/14/2023
 

Point of Contact

Emmanuel T. Mbah, Phone: 2404027598
 

E-Mail Address

Emmanuel.mbah@fda.hhs.gov
(Emmanuel.mbah@fda.hhs.gov)
 

Description

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.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/168d770241fd41b8a8b2eab9b14ec1e6/view)
 

Place of Performance

Address: Silver Spring, MD 20903, USA

Zip Code: 20903

Country: USA
 

Record

SN06737978-F 20230708/230706230044 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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