METADATA
last updated: 2026-03-22 AI
file_name: _AI_FDA COVID-19 Diagnostic Test EUA Staffing and Review Timing.md
file_date: 2026-03-22
title: FloodLAMP FDA COVID-19 Diagnostic Test EUA Staffing and Review Timing
category: regulatory
subcategory: fda-policy
tags: COVID-19, diagnostics, EUA, FDA, staffing, review-timing, CDRH, OHT7, OIR
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license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
tokens: 3002
words: 1902
notes: Created by ChatGPT 5.4 Pro during archive preparation. **NOT HUMAN VERIFIED - MAY CONTAIN ERRORS** Synthesizes two separate ChatGPT responses on FDA staffing and review timing for COVID-19 diagnostic test EUAs, drawing on GAO-22-104266, FDA's Deliverable 15 EUA Assessment, MDUFA V meeting records, HHS OIG evaluation OEI-01-20-00380, and FDA annual MCMi reports and congressional testimony. Filtered to exclude non-diagnostic EUAs (serology, therapeutics, vaccines, non-IVD devices).
summary_short: Compilation of publicly available data on FDA staffing levels and review timelines for COVID-19 diagnostic test (molecular and antigen) EUAs, covering CDRH OHT7/OIR workforce growth from 60 to 180 staff, review-time trends from 14-day to 99-day medians and back, submission outcomes and refusal reasons, and the key federal sources for each metric.


CONTENT

## Diagnostic Test EUA Review Staffing and Headcount

For COVID-19 diagnostic test EUAs, the substantive review office was CDRH's OPEQ-OHT7, also referred to as OIR (the Office of In Vitro Diagnostics and Radiological Health). FDA's own EUA assessment says OHT7 made the authorization or denial recommendation and sent it to OCC and OCET, with OCET providing final sign-off. The office encompassed divisions for chemistry/toxicology, immunology/hematology, microbiology, molecular genetics/pathology, and program operations. FDA's 2022 reorganization retitled OIR as OHT VII, splitting out Radiological Health and Mammography Quality Standards into OHT VIII. [1] [3]

### Headcount

The clearest public numeric disclosure is in a 2022 GAO report (GAO-22-104266): **FDA officials told GAO the agency increased staff working on COVID-19 test EUAs from 60 in March 2020 to 180 by March 2021.** The same report says FDA reassigned nearly all staff in the Division of Microbiology Devices to COVID work in March 2020, leaving only two staff on non-COVID devices, and that the division added 28 reviewers from the beginning of 2020 to November 2021. [2]

FDA's own EUA assessment (Deliverable 15) gives the best office-wide workload measure, expressed as a percentage rather than a headcount: 61% to 84% of OHT7 staff, excluding Radiological Health and Mammography Quality Standards, were working on the COVID response from April 2020 through March 2021. That figure was 70% in April 2020 and peaked at 84% in February and March 2021, encompassing both review and non-review work. Because this metric differs from GAO's 60-to-180 headcount, a back-solved total-office size should not be treated as a published FDA number. [1]

### Management Versus Reviewers

No public pandemic-era headcount table cleanly splits OIR/OHT7 into managers and reviewers. The strongest public disclosure comes from the FDA-Industry MDUFA V reauthorization meeting on October 7, 2021: **former OIR had about an 11:1 ratio of review staff to front-line supervisors.** That figure excluded team leads and additional division/office management. At the broader OPEQ level, the total manager-to-staff ratio was slightly lower than 8:1. FDA grouped OPEQ staff into TPLC reviewers, medical officers, statisticians/epidemiologists/policy-program staff, managers, and administrative support staff, but did not publish actual counts by category. [4]

### MDUFA FTE Clarification

FDA's annual MDUFA performance reports show much smaller OHT7 figures -- 45.7 in FY2020 and 43.0 in FY2021 -- but those are explicitly labeled "MDUFA Program FTEs Funded by Budget Authority," not total office headcount. The FY2020 change reflected COVID-related workload priority shifts. These MDUFA numbers are not the same as the pandemic EUA-review workforce. [4]

### Key Staffing Sources

| # | Source | Use For |
| --- | --- | --- |
| 1 | Deliverable 15: Emergency Use Authorization Assessment - Final Report | OHT7's role, OCET sign-off, Figure 3-2 on share of OHT7 staff on COVID |
| 2 | GAO-22-104266 | 60 to 180 staffing, two non-COVID staff, +28 reviewers |
| 3 | Federal Register: Statement of Organization, Functions, and Delegations of Authority | OIR to OHT VII/OHT VIII renaming and split |
| 4 | FDA-Industry MDUFA V Reauthorization Meeting, October 7, 2021 | 11:1 review-staff-to-supervisor ratio and staff-role categories |
| 5 | FDA EUA guidance page and OHT7 office page | FDA-wide EUA review structure and IVD office responsibilities |
| | | |


## Diagnostic Test EUA Review Timing and Outcomes

The most detailed public statistics on COVID-19 EUA review performance are for diagnostic test EUAs handled by CDRH. All figures below cover IVD EUA submissions, which include molecular, antigen, and serology tests in the aggregate totals. Where molecular-specific breakdowns are available, they are noted. Serology (antibody) tests, while categorized as IVDs by FDA, are not diagnostic tests for active infection and are excluded from this analysis where the data permits.

### Submission Volume

Between March 2020 and March 2021, CDRH handled 3,672 COVID-19 IVD submissions when counting 1,070 pre-EUAs plus original EUA requests and supplements. Monthly volume peaked at 554 submissions in April 2020. [1]

By April 12, 2021, CDRH had closed out 2,133 COVID-19 test EUA requests. Of those, 61% were molecular tests, 29% serology, and 9% antigen. CDRH had authorized or acknowledged 812 of those requests and separately reported 360 original authorized IVD EUAs by that date. [1]

By March 11, 2022, FDA said it had received about 8,000 device EUA and pre-EUA requests since January 2020 and was still receiving over 130 per month. In June 2022, FDA similarly reported more than 8,000 device EUA and pre-EUA submissions with nearly 120 per month still arriving. [8]

Cumulative IVD EUA totals grew steadily: 486 by the end of FY2022, 531 by FY2023, and 553 by FY2024 (these totals include revoked or terminated EUAs, and some "umbrella" EUAs count as one even when multiple products were covered). [6] [7]

New-EUA counts also understate the re-review workload. FDA reported 1,494 revisions to COVID-19 IVD EUAs from March 2020 through September 2024. [9]

### Outcomes for Diagnostic Test EUA Requests

For all COVID-19 test EUA requests closed by April 12, 2021, FDA reported this outcome mix:

| Outcome | Count | Share |
| --- | --- | --- |
| Authorized or acknowledged | 812 | 38% |
| Declined to review | 460 | 22% |
| Withdrawn | 348 | 16% |
| Declined to issue or denied | 280 | 13% |
| Closed with requests for information | 233 | 11% |
| **Total closed** | **2,133** | **100%** |
| | | |

For the molecular-test subset alone, outcomes were somewhat better on authorization but still showed heavy triage:

| Outcome | Count | Share |
| --- | --- | --- |
| Authorized or acknowledged | 642 | 50% |
| Declined to review | 315 | 24% |
| Withdrawn | 145 | 11% |
| Closed with requests for information | 109 | 8% |
| Declined to issue or denied | 83 | 6% |
| **Total closed** | **1,294** | **100%** |
| | | |

For original molecular EUA requests, FDA reported meaningful differences by developer type. Commercial manufacturers were authorized more often than laboratories (37% vs. 25%). Laboratories were much more likely to be declined to review (48% vs. 22%), which FDA tied to the deprioritization of many LDT requests in October 2020 after the HHS statement on LDT oversight. [1]

### Reasons for Non-Authorization

**Declined to issue or denied** meant the request had critical deficiencies the sponsor could not fix in a reasonable time. FDA gave examples such as significant validation problems and inadequate or missing performance data. [1]

**Declined to review** was used for low-priority files without full review. FDA gave examples such as highly manual, low-volume, low-throughput tests or tests with limited public-health impact. FDA framed this as triage toward products more likely to improve testing capacity or access during the emergency. [1]

**Closed with requests for information** meant FDA needed additional information to support authorization, but that information was not readily available. The file could later be reopened if the submitter provided it. [1]

**Withdrawn** meant the submitter voluntarily pulled the request. FDA says that happened for a variety of reasons, including after receiving deficiencies from FDA or because the developer chose to use a more flexible policy path that did not require a separate EUA. [1]

HHS OIG reported that FDA's decision to accept all incoming COVID test EUA requests generated a record number of submissions, often low-quality and from developers lacking experience with FDA processes. A later FDA analysis of 125 EUA requests for lab-developed diagnostic tests found 82 had design or validation problems. [10]

### Review Timing

FDA did not publish a standardized KPI called "time to first response" for COVID diagnostic test EUAs. What FDA publicly reported were a mix of end-to-end review times, operational goals, and specific early examples. [1]

**Earliest-response examples.** The CDC submitted its first COVID diagnostic EUA request on February 3, 2020, and FDA issued the EUA on February 4, 2020. FDA later said that at the beginning of the pandemic it was authorizing some tests in as little as 1-2 days upon receipt of complete data packages. [11]

**Median review time for authorized original test EUAs** rose from 14 days for the March 2020 submission cohort to 92 days for September 2020 and 99 days for November 2020, then dropped to 7 days for the February and March 2021 cohorts. [1]

**Median review time for declined-to-issue or denied originals** was much longer early on -- 152 days for March 2020 and 186 days for April 2020 -- before improving to 66 days for October 2020, 61 days for November-December 2020, and 17-38 days for February-March 2021 cohorts. [1]

FDA's own later summary described the same arc more simply: review times for IVD EUA requests rose to as much as 90 days for requests received in September 2020, then improved to less than 40 days on average for closed IVD EUA requests received in February 2021. In separate June 2022 testimony, FDA said the average total time to decision for original IVD EUAs received in calendar year 2021 was 54 days, with 91% of 2021 submissions closed. [12]

**Express and Standard Track lanes.** In fall 2020, CDRH created Express Track and Standard Track review lanes for EUA requests. For Express Track files, FDA said the goal was for the review team to make recommendations within 30 days. **Tests evaluated through the NIH/FDA ITAP pathway had an average review time of just over a week, and could be as short as one day, after FDA received a complete data package.** [1] [12]

**First-response experience.** The public record on first-response timing is mostly qualitative. FDA's assessment says stakeholders frequently asked for timeline updates, and that response times were faster in the beginning and became less frequent as submission volume increased. HHS OIG likewise found that some developers reported hearing nothing from FDA for weeks or months, and some developers who eventually received a decline to review had been waiting 5 months or more before that decision. Starting in November 2020, FDA sometimes gave developers only 24-48 hours to respond to comments during interactive review, and 32% of surveyed developers said meeting those deadlines was challenging or somewhat challenging. [1] [10]


## References

| # | Source | URL |
| --- | --- | --- |
| 1 | Deliverable 15: Emergency Use Authorization Assessment - Final Report | https://www.fda.gov/media/152992/download |
| 2 | GAO-22-104266: FDA's COVID-19 Test EUA Staffing | (GAO report, no direct URL in source material) |
| 3 | Federal Register: Statement of Organization, Functions, and Delegations of Authority (OIR to OHT VII/VIII) | (Federal Register notice, no direct URL in source material) |
| 4 | FDA-Industry MDUFA V Reauthorization Meeting, October 7, 2021 | (meeting record, no direct URL in source material) |
| 5 | FDA EUA Guidance Page and OHT7 Office Page | https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization |
| 6 | FY2022 MCMi Program Update | https://www.fda.gov/media/165347/download |
| 7 | FY2024 MCMi Program Update | https://www.fda.gov/media/179377/download |
| 8 | FDA Testimony on Device EUA Submissions | https://www.fda.gov/media/157948/download |
| 9 | FDA MCMi Publications and Reports | https://www.fda.gov/emergency-preparedness-and-response/about-mcms/publications-and-reports |
| 10 | HHS OIG: FDA Repeatedly Adapted EUA Policies (OEI-01-20-00380) | https://oig.hhs.gov/documents/evaluation/2617/OEI-01-20-00380-Complete%20Report.pdf |
| 11 | FDA Congressional Testimony, May 12, 2020 | https://www.fda.gov/news-events/congressional-testimony/covid-19-safely-getting-back-work-and-back-school-05122020 |
| 12 | FDA Congressional Testimony, November 4, 2021 | https://www.fda.gov/news-events/congressional-testimony/next-steps-road-ahead-covid-19-response-11042021 |
| | | |