Amend 75F4012Q00045_P00001 Q A 1226556. 05082020.pdf
PDF 82 KB Posted
- Solicitation number
- 75F40120Q00045
About this file
This document contains questions and answers related to a solicitation for material performance study services. The U.S. Food and Drug Administration Center for Devices and Radiological Health seeks safety profiles for up to 50 commonly used materials by medical application. The solicitation anticipates awarding a firm fixed price contract for these services, with an anticipated start date based on the award date. The questions and answers clarify that appendices may be included in proposals, the page limit applies only to Volume 1, the precise number of required materials is unknown but is estimated at 40 initially with up to 10 more possible, and the agency will provide information on medical devices associated with the materials to be reviewed during contract performance.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| WD 2015-4281 12232019.pdf | ||
| Combined Synopsis_Solicitation 1226556 04212020.pdf |
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
75F4012Q00045_P00001 Material Performance Study Questions and Answers 05/07/2020
1. Question: May an appendix be included to Volume 1 for supplemental and required information such as biographies of potential staff members, Certifications and Representations, the catalog or published price listing applicable to this service, etc.?
Answer: Yes.
2. Question: Can FDA please confirm what information is included in the page limit for Volume 1 (i.e., organizational capabilities, project description and plan)?
Answer: Combined Synopsis/Solicitation and clauses and provisions FAR Part 52.212-1 AND FAR Part 52.212-2 should be referenced and followed.
3. Question: The number of scientific materials in Table 1 Deliverables (pages 4 and 5) totals 40;
however, the Objective (page 1, A. Statement of Work) indicates that FDA would like “safety profiles for up to 50 commonly used materials by medical application.” Please confirm the correct number of materials for the proposed project. If the total is 50, then when would the remaining 10 profiles be due to FDA?
Answer: We currently do not know the precise number of materials that might be needed because new reports of potential problems can arise on an ongoing basis. We have identified 40 materials that we know are of interest, but there might be up to 10 additional materials to be added.
4. Question: Is there an FDA repository linking medical devices to component fundamental materials?
Answer: not currently, although a repository is being considered as a part of future plans.
If so, is there a searchable means to review this database?
Answer: That will be part of the design specifications, but currently N/A.
5. Question: In order to ensure targeted searches, can FDA, during the project, provide the awardee with high interest medical devices that are associated with the material to be reviewed?
Answer: Yes, we would be happy to do that.
6. Question: Does the FDA have an anticipated project start date?
Answer: The anticipated project start date is based upon the award date.
File details come from the government source that posted it. Updated .