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Engage in the World Health Organization (WHO) pre-qualification of diagnostics pilot programme for HIV

Description: The WHO prequalification of diagnostics programme aims to increase access to affordable diagnostic technologies of assured quality that are appropriate for use in resource limited settings. FDA’s Office of Blood Research and Review (OBRR) voluntarily provides scientific review input to the WHO regarding HIV test dossiers.

FY 2021 Updates

Milestone Description	Milestone Date	Milestone Status	Milestone Completion Date
No update to report this quarter	Quarter 1	Completed	Quarter 1
No update to report this quarter	Quarter 2	Completed	Quarter 2
No update to report this quarter	Quarter 3	Completed	Quarter 3
No update to report this quarter	Quarter 4	Completed	Quarter 4

FY 2020 Updates

Milestone Description	Milestone Date	Milestone Status	Milestone Completion Date
No update to report this quarter	Quarter 1	Completed	Quarter 1
No update to report this quarter	Quarter 2	Completed	Quarter 2
No update to report this quarter	Quarter 3	Completed	Quarter 3
Reviewed the following documents for WHO-PQ (IVD) program and provided the comments: (1) Collaborative Procedure Between the World Health Organization (Who); and (2) National Regulatory Authorities in the Assessment and Accelerated National Registration of WHO-Prequalified In Vitro Diagnostics (IVDs).	Quarter 4	Completed	Quarter 4

FY 2019 Updates

Milestone Description	Milestone Date	Milestone Status	Milestone Completion Date
No update to report this quarter	Quarter 1	Completed	Quarter 1
No update to report this quarter	Quarter 2	Completed	Quarter 2
The WHO Prequalification group for Invitro Diagnostics (IVD) is intending to publish new Technical Specifications documents for HIV and HCV NAT diagnostic tests. A small group of participants with expertise in regulatory review, laboratory evaluation, procurement and users of HCV and/or HIV NAT assays was convened on May 27-29, 2019 to discuss the draft documents. Pradip Akolkar PhD, CBER/OBRR, participated in this Technical Specifications discussion.	Quarter 3	Completed	Quarter 3
The WHO Prequalification group drafted three Technical Series documents - HCV NAT, HIV-1 qualitative NAT, and HIV-1 quantitative NAT. The two draft HIV-1 NAT Technical Series documents were reviewed by OBRR; comments communicated to WHO on October 16, 2019.	Quarter 4	Completed	Quarter 4

FY 2018 Updates

Milestone Description	Milestone Date	Milestone Status	Milestone Completion Date
No update to report this quarter	Quarter 1	Completed	Quarter 1
No update to report this quarter	Quarter 2	Completed	Quarter 2
No update to report this quarter	Quarter 3	Completed	Quarter 3
No update to report this quarter	Quarter 4	Completed	Quarter 4

FY 2017 Updates

Milestone Description	Milestone Date	Milestone Status	Milestone Completion Date
CBERs Office of Blood Research and Review (OBRR) provided detailed comments/edits on two documents: (1) Technical Specification Series (TSS-1,) Draft Technical Specification for WHO Prequalification of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests for Professional Use and/or Self-Testing; and (2) WHO Global Model Regulatory Framework for Medical Devices Including in-vitro diagnostic devices (IVDs).	Quarter 1	Completed	Quarter 1
No update to report this quarter	Quarter 2	Completed	Quarter 2
The 4th Annual Meeting of the WHO Prequalification of In vitro Diagnostics assessors and inspectors was held in Geneva, Switzerland (April 25-27, 2017). Dr. Pradip Akolkar attended as the CBER representative. The meeting focused on the issues that the dossier assessors and inspectors faced during the first year of the program. The program pre-qualified 20 In Vitro Diagnostics (IVDs), of which 18 were HIV diagnostic kits and two were for Malaria diagnostics. In addition, there was a discussion about using the mechanism in place for the International Medical Device Regulators Forum (IMDRF) and the use of the documentation prepared by IMDRF for Medical Device Single Audit Program. There was also a discussion regarding the periodic (e.g., Annual Report), reporting of changes to the devices, significant manufacturing changes, and re-inspection of the facilities. The option of leveraging the routine inspections performed through Medical Device Single Audit Program was discussed.	Quarter 3	Completed	Quarter 3
In August 2017, as part of WHO Prequalification program, CBER/OBRR reviewed two final guidelines: 1) Stability Program for IVD Devices; and 2) HIV Rapid Test and/or HIV Self-test. Previously, OBRR provided input to the draft guidelines document on HIV Rapid Test and/or HIV Self-test.	Quarter 4	Completed	Quarter 4

FY 2016 Updates

Milestone Description	Milestone Date	Milestone Status	Milestone Completion Date
Dr. Akolkar has been invited to the 3rd Annual Meeting of WHO Prequalification of In Vitro Diagnostics Dossier and Inspectors to be held in Geneva, Switzerland on 19-21 April 2016.	Quarter 1	Completed	Quarter 1
No update to report this quarter	Quarter 2	Completed	Quarter 2
No update to report this quarter	Quarter 3	Completed	Quarter 3
No update to report this quarter	Quarter 4	Completed	Quarter 4

FY 2015 Updates

Milestone Description	Milestone Date	Milestone Status	Milestone Completion Date
Attended WHO Prequalification Team – Diagnostics Working Group meeting in April 2014. Finalized the streamlining and updating of the dossier instructions and guidance. Addressed issues related to facility inspection and laboratory testing of kits. Reconfirmed FDA’s commitment to review one dossier in the next year – waiting for the dossier.	Quarter 1	Completed	Quarter 1
Reviewed dossiers for two HIV diagnostic assays (one for third Generation assay and one for fourth generation assay) from the same manufacturer. The dossiers did not meet any scientific or regulatory requirements. A detailed report will be sent to WHO in April 2015 on the findings. OBRR attended the second annual meeting of WHO prequalification program for in vitro diagnostic assessors and inspectors in Geneva (March 10-14, 2015).	Quarter 2	Completed	Quarter 2
No update to report this quarter	Quarter 3	Completed	Quarter 3
OBRR attended the World Health Organization (WHO) collaborating meeting in July 2015 and participated in discussions related to the tasks and expectations for the WHO Prequalification and Diagnostic Program. Highlights of the meeting on this topic were: (1) WHO IVD prequalification will be covered by ECBS from 2015 onwards; (2) The IVD program will lead the development of a set of guidance documents and training sessions to assist manufacturers of IVDs; and (3) The need for clear regulatory requirements on the use of reference materials. Furthermore, these materials need to be commutable and fit for work outside of Europe and the United States, e.g. in Africa.	Quarter 4	Completed	Quarter 4

FY 2014 Updates

Milestone Description	Milestone Date	Milestone Status	Milestone Completion Date
No updates to report against this initiative during the quarter.	Quarter 1	Completed	Quarter 1
The Deputy Director for OBRR/DETTD participated in a meeting at WHO (March 31 to April 4, 2014) that was convened to finalize the program.	Quarter 2	Completed	Quarter 2
Waiting for WHO to finalize the program and provide the documents for review.	Quarter 3	Completed	Quarter 3
No update to report this quarter	Quarter 4	Completed	Quarter 4

FY 2013 Updates

Milestone Description	Milestone Date	Milestone Status	Milestone Completion Date
No updates to report against this initiative during the quarter.	Quarter 1	Completed	Quarter 1
Waiting for WHO to send dossier for FDA to review.	Quarter 2	Completed	Quarter 2
Currently WHO is in the process of revising their re-qualification programs; review of the dossiers for HIV diagnostic tests are on hold.	Quarter 3	Completed	Quarter 3
The entire pre-qualification program at WHO (for vaccines, medicines, IVDs) is being re-evaluated and restructured. OBRR will proceed with the commitment that has already been made for evaluation of an HIV dossier when made available.	Quarter 4	Completed	Quarter 4

Key Projects Legend

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Not Yet Started	Work for specific milestone has not yet been started.
Completed	Milestone and/or overall project is completed.
On Track	Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On Hold	Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
Delayed	Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.