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last updated: 2026-03-02 RT initial creation
file_name: _AI_FDA Deprioritization of COVID-19 Diagnostic EUAs.md
file_date: 2026-03-02
title: FloodLAMP FDA Deprioritization of COVID-19 Diagnostic EUAs (CDRH/OHT7)
category: regulatory
subcategory: fl-fda-correspondence
tags: fda-deprioritization, eua, covid-diagnostics, cdrh, oht7, decline-to-review, gao
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notes: Created by ChatGPT 5.2 Pro Extended during archive preparation. **NOT HUMAN VERIFIED - MAY CONTAIN ERRORS** Comprehensive analysis of FDA CDRH/OHT7's deprioritization practices for COVID-19 diagnostic EUA submissions, drawing from FDA's Booz Allen independent assessment, GAO-22-104266, FDA town hall transcripts, Food and Drug Law Journal analysis (Gibbs & Javitt), Reuters reporting, and ProPublica reporting.
summary_short: FDA CDRH/OHT7 deprioritization of COVID-19 diagnostic EUA submissions -- history, mechanics, emergence as a policy tool, comparison with 510(k) processes, prior emergency precedents, scale (558 EUA requests declined to review by Sept. 2021 per GAO), and independent analyses of transparency, resource constraints, and relationship to Omicron-era testing shortages.


CONTENT

***INTERNAL TITLE:*** FDA "Deprioritization" of COVID-19 Diagnostic EUAs (CDRH/OHT7)

History, mechanics, how it emerged, how it compares to 510(k), prior emergencies, and what analyses say.

## Executive summary

- During COVID-19, FDA's device center (CDRH)--specifically the in-vitro diagnostics review function (often referenced in FDA materials as OHT7)--created an explicit **triage + deprioritization** system to manage an unprecedented surge of SARS-CoV-2 test requests. ([U.S. Food and Drug Administration][1])
- In FDA's own post-event assessment materials, "deprioritization" is not just an informal concept; it was operationalized via **two streamlined negative actions**:
  - **Decline to Review** (for low-priority files--e.g., highly manual / low-volume, or low manufacturing capacity), and
  - **Decline to Issue** (for higher-priority tests with unresolved critical deficiencies, especially validation/performance data problems). ([U.S. Food and Drug Administration][1])
- FDA publicly telegraphed these priorities in town halls. In March 2021, for example, FDA explicitly warned that some submissions would be "very low priority" and "might be deprioritized," while encouraging developers to pursue point-of-care or at-home pathways. ([U.S. Food and Drug Administration][2])
- The scale was large: GAO reported FDA had **declined to review 558 EUA requests** for COVID-19 tests as of **Sept. 30, 2021** (including **230 LDTs**). ([Government Accountability Office][3])
- "Deprioritization" as used in EUA review is **not the same thing** as what happens in a 510(k). In 510(k), FDA uses formal completeness gates like **Refuse to Accept (RTA)** to focus resources on submissions that meet a minimum threshold for substantive review, and the program operates under performance goals and structured review steps--not open-ended discretionary triage in the same way. ([U.S. Food and Drug Administration][4])
- Independent and semi-independent analyses (FDA-commissioned assessment, GAO, academic/legal analysis, investigative journalism) repeatedly identify **resource constraints, backlog management, changing public-health needs, and test-quality concerns** as drivers--while also critiquing **transparency, predictability, and "wasted effort"** when priorities changed without clear notice. ([U.S. Food and Drug Administration][1])
- On the question of whether deprioritization contributed to the Omicron test shortage: there is clear documentation of **severe shortages and long lines** during Omicron, but public sources do **not** establish a simple one-to-one causal link from EUA deprioritization decisions in spring/summer 2021 to the January 2022 shortage. The strongest public record supports a **multi-factor explanation**, including demand shocks and manufacturing/investment incentives. ([Reuters][5])

---

## 1) Who at FDA was doing this

**CDRH** (Center for Devices and Radiological Health) is FDA's center responsible for medical devices, including most in vitro diagnostics (IVDs). In the COVID diagnostics context, FDA's own EUA process description references **OHT7** as the office making recommendations on authorization/denial, with additional legal/policy signoffs (OCC and OCET) and different signature authorities depending on the type of decision. ([U.S. Food and Drug Administration][1])

GAO's review of FDA's COVID test oversight highlights the staffing surge and strain: FDA increased staff working on COVID test EUAs and reallocated from other work, with effects on non-COVID diagnostic reviews; FDA officials told GAO they began shifting staff back to non-COVID work around May 2021. ([Government Accountability Office][3])

---

## 2) What "deprioritization" meant in practice

### 2.1 FDA's internal definition (as reflected in FDA-published assessment materials)

FDA's EUA assessment materials (an FDA "perspective" document sharing Booz Allen Hamilton's independent assessment and FDA's response) describe a **front-end triage** and **formal prioritization factors**--followed by **deprioritization processes** that allowed FDA to dispose of certain submissions faster. ([U.S. Food and Drug Administration][1])

The assessment document lays out:

**Prioritization factors** (Table 3-5):

- **Increases testing capacity** (e.g., large-scale manufacturing/processing, high-throughput, high product volume, or reduced reliance on limited supplies like by using saliva).
- **Expands test accessibility** (e.g., point-of-care, home collection, at-home).
- **Reduces real-world performance concerns** (tests already offered under notification policy where FDA identified performance concerns). ([U.S. Food and Drug Administration][1])

**Deprioritization mechanisms** (the core of the question):

- **Decline to Review**: used for "low-priority files" (example given: highly manual, low-volume tests; or low throughput / low manufacturing capacity). FDA would close the file and communicate the decision and reason. ([U.S. Food and Drug Administration][1])
- **Decline to Issue**: used for priority tests with "critical deficiencies" (e.g., inadequate or missing performance data) that the requestor could not resolve in a reasonable time; FDA would notify deficiencies and allow follow-up if the requestor addressed concerns. ([U.S. Food and Drug Administration][1])

A key detail: the assessment notes that before these mechanisms, FDA processed negative decisions as "Denials" requiring higher-level issuance; the streamlined approach helped reviewers focus on higher-impact and more complete requests. ([U.S. Food and Drug Administration][1])

### 2.2 How this differed from "denial" and from "incomplete submission" handling

The same assessment describes other process changes implemented to handle incomplete submissions and reduce iterative back-and-forth:

- A **content screen** and a process to **close files with requests for information**, allowing requestors to resubmit requested information later. ([U.S. Food and Drug Administration][1])

GAO similarly distinguishes:

- FDA may **decline to issue** if the submission lacks necessary data for substantive review, and
- FDA may **decline to review** if the test is not a priority at that stage of the emergency. ([Government Accountability Office][3])

---

## 3) When and how "deprioritization" emerged as a policy tool during COVID

### 3.1 Spring 2020: triage begins; serology becomes a major stress test

A major early example where "deprioritization" (or a shift in review priority) is discussed in the literature is **serology (antibody) tests**.

A Food and Drug Law Journal analysis (Gibbs & Javitt) describes what it characterizes as a "rollercoaster" for serology EUAs: after FDA required EUAs for serology tests (May 4, 2020), FDA was overwhelmed by submissions and applicants experienced long periods in a "backlog" with limited clarity. ([Food and Drug Law Institute (FDLI)][6])

That paper reports that only a few months after requiring EUA submissions, anecdotal reports emerged that FDA would "deprioritize" serology EUAs; it says FDA put serology reviews on hold before announcing it clearly, leading to months of waiting and wasted effort for some applicants. ([Food and Drug Law Institute (FDLI)][6])

### 3.2 Fall 2020: formalized front-end triage; "Decline to Review" letters become a visible instrument

FDA's EUA assessment materials describe the inflection point:

- **Beginning in Fall 2020**, CDRH instituted a **front-end triage and prioritization process** for all EUA requests due to submission volume far beyond prior emergencies. ([U.S. Food and Drug Administration][1])
- The same assessment states that CDRH did not begin implementing the **Decline to Review** process "until October 2020," after more than 250 EUAs for tests/collection devices had been authorized. ([U.S. Food and Drug Administration][1])

### 3.3 October 7, 2020: public statement--declining to review LDT EUAs "at this time"

An October 7, 2020 FDA virtual town hall transcript captures FDA publicly stating that--given the phase of the pandemic, many authorized tests, and the HHS announcement about LDT premarket review--FDA was **declining to review EUA requests for LDTs at that time**, while continuing to prioritize POC, home collection, at-home, supply-chain-relieving, and high-throughput/widely distributed tests. ([U.S. Food and Drug Administration][7])

The EUA assessment report adds a quantitative detail tied to that policy move: after the August 2020 HHS statement, CDRH **declined to review over 200 LDT EUA requests in October**--framed as allowing CDRH to focus on tests that could not be offered without FDA review/authorization (e.g., home collection, POC, multi-analyte panels). ([U.S. Food and Drug Administration][1])

### 3.4 Early 2021 (including March): explicit language about deprioritization and "what's needed right now"

Two March 2021 town hall excerpts are particularly on-point:

- **March 10, 2021:** Dr. Timothy Stenzel stated that submitting only for high/moderate complexity "is a very low priority and you might be deprioritized," and encouraged moving to the home study / home test pathway if performance supports it. ([U.S. Food and Drug Administration][2])

- **March 31, 2021:** FDA reiterated that prioritization decisions depend on many factors; it again named the accessibility and capacity priorities. Dr. Stenzel added that "at this time [the] pandemic is very different" and that FDA sought to "focus review attention and prioritization" and incentivize development of tests "really needed right now," emphasizing high-volume accurate results in lab or at home/POC. ([U.S. Food and Drug Administration][8])

This aligns closely with the deprioritizations clustering when FDA perceived a shift in market/public-health conditions.

### 3.5 Mid-late 2021: "deprioritized previously" explained (manufacturing capacity / deficiencies)

In an August 4, 2021 town hall transcript, FDA stated that if an EUA request was deprioritized previously, it was likely because the test either:

- had **low manufacturing or testing capacity**, or
- the submission was **deficient** in some way. ([U.S. Food and Drug Administration][9])

That is one of the clearest public "rule-of-thumb" explanations from FDA itself.

### 3.6 By Sept. 30, 2021: the scale--hundreds of EUA requests declined to review

GAO reported that FDA officials said as of **Sept. 30, 2021**, FDA had **declined to review 558 EUA requests** for COVID-19 tests, including **230 LDTs**. ([Government Accountability Office][3])

This provides a public, audited figure consistent with "hundreds" and gives an anchor for the scale of "deprioritization" as "decline to review."

---

## 4) What drove the policy: FDA's stated rationale and operational constraints

Across FDA's assessment materials, town halls, and GAO, the same drivers repeatedly appear:

### 4.1 Unprecedented submission volume and backlog management

The EUA assessment notes that early in the pandemic, when few tests were authorized, "every test was a priority," but as tests proliferated, that level of interaction became unsustainable, necessitating prioritization factors. ([U.S. Food and Drug Administration][1])

GAO reports that FDA received thousands of EUA requests over the period and that review times increased as volume increased. ([Government Accountability Office][3])

### 4.2 Focus on public health impact: accessibility + capacity + supply chain

FDA consistently framed prioritization around tests that:

- expand where/how testing can occur (POC, home collection, at-home), and
- increase national capacity (high throughput, high volume, reduced reliance on scarce supplies). ([U.S. Food and Drug Administration][1])

The EUA assessment also describes how **supply chain monitoring** fed into review priorities, including pivots when swab shortages emerged (e.g., prioritizing saliva specimen approaches). ([U.S. Food and Drug Administration][1])

### 4.3 Manufacturing and testing capacity as an explicit gate

FDA town halls repeatedly tied priority to **capacity**, and FDA's August 2021 town hall made that explicit in the deprioritization explanation. ([U.S. Food and Drug Administration][9])

GAO also captures FDA's later articulation (in the revised 2021 guidance) that FDA viewed authorization of tests with manufacturing capacities below a large threshold as insufficient to scale national capacity--illustrating that capacity was not just a nice-to-have; it became a central criterion. ([Government Accountability Office][3])

### 4.4 Quality and validation concerns (and avoiding prolonged review loops)

FDA's assessment frames "Decline to Issue" as a way to stop spending time on submissions with major unresolved validation problems. ([U.S. Food and Drug Administration][1])

Separately, the legal/academic analysis of serology describes situations in which applicants sometimes had very short windows (e.g., "forty-eight hours") to respond to questions--highlighting the tension between speed and completeness in emergency review. ([Food and Drug Law Institute (FDLI)][6])

---

## 5) Was "deprioritization" used before COVID in other emergencies?

### 5.1 EUA existed pre-COVID and IVD EUAs were issued in multiple emergencies

FDA documents summarizing EUA practice list multiple emergencies in which FDA authorized IVDs under EUA, including:

- influenza A H1N1 (2009),
- avian influenza A H7N9 (2013),
- MERS-CoV (2013),
- Ebola (2014),
- Enterovirus D68 (2015),
- Zika (2016),
- COVID-19 (2020), and
- mpox (2022). ([U.S. Food and Drug Administration][10])

### 5.2 But the "deprioritization" machinery appears to be a COVID-scale response

FDA's EUA assessment explains that the "substantially higher submission volume" during COVID compared to prior public health emergencies made a **formal set of prioritization factors necessary**, and it describes Fall 2020 as the point where triage and streamlined "Decline to Review / Decline to Issue" mechanisms were instituted to manage backlog. ([U.S. Food and Drug Administration][1])

That suggests:

- **Prior PHEs** likely involved prioritization in the ordinary sense (resource focus), but
- **COVID** created enough volume/complexity that "deprioritization" became a structured, named workflow with standardized negative actions, and it became widely visible to submitters.

---

## 6) Is there an equivalent "deprioritization" in 510(k)? Not really--here's the closest analog

### 6.1 EUA vs 510(k) in one sentence

- **EUA** is an emergency, discretionary authorization mechanism where FDA can choose not to review certain categories at a given moment to maximize public health benefit. ([FDA Law Blog][11])
- **510(k)** is a standard premarket pathway with structured acceptance and substantive review steps; FDA focuses resources by screening completeness (RTA) rather than by declining review because a product category is "low priority." ([U.S. Food and Drug Administration][4])

### 6.2 The closest analog: "Refuse to Accept (RTA)" and other gates

FDA's **Refuse to Accept Policy for 510(k)s** explains that its purpose is to determine whether a 510(k) meets a minimum threshold of acceptability and should be accepted for substantive review--explicitly framing this as a way to focus review resources on complete submissions. ([U.S. Food and Drug Administration][4])

FDA's 510(k) submission process page describes that after the acknowledgement letter, the submission routes to the appropriate office and that the lead reviewer conducts acceptance review using the RTA checklist. ([U.S. Food and Drug Administration][12])

**Key distinction:**
RTA is about **administrative/threshold completeness**. COVID EUA "deprioritization" (Decline to Review) was often about **public-health priority and impact**, including volume/capacity and what FDA perceived the country needed at that phase--*even if the submission might be technically complete*. ([U.S. Food and Drug Administration][1])

---

## 7) What analyses and critiques exist about "deprioritization" and its effects?

There is not a single definitive "cost-benefit" study that proves counterfactual outcomes (e.g., "X more tests would have been on shelves by Omicron absent deprioritization"). But there *is* meaningful analysis and documented stakeholder critique.

### 7.1 FDA's own after-action framing (independent assessment shared by FDA)

FDA's published assessment materials (sharing Booz Allen's independent assessment plus FDA perspective) depict deprioritization as a necessary operational response to:

- backlog,
- resource limits,
- incomplete/low-quality submissions, and
- changing PHE needs. ([U.S. Food and Drug Administration][1])

### 7.2 GAO: documented scale + stakeholder concerns about uncertainty (especially LDTs)

GAO documents the "decline to review" scale (558 by Sept. 30, 2021), and notes that laboratory associations expressed unfavorable views of declining to review LDT EUAs because it created uncertainty/confusion, including around insurance coverage and PREP Act liability protections. ([Government Accountability Office][3])

### 7.3 Legal/academic critique: transparency and wasted effort (notably serology)

The Food and Drug Law Journal analysis is explicit that lack of clarity about shifting priorities can waste developer effort and create confusion--particularly in serology, where the authors describe an unannounced shift in review priorities and long periods without meaningful communication. ([Food and Drug Law Institute (FDLI)][6])

### 7.4 Industry/legal commentary: "deprioritization risk" as a planning hazard

A prominent FDA law blog post (Feb 2021) describes deprioritization as a significant risk in pursuing EUAs under changing market conditions, gives examples (including diagnostics), and argues for more transparency--e.g., a public database of deprioritized categories. ([FDA Law Blog][11])

### 7.5 Case reporting: applications told they'd be "deprioritized"

ProPublica reported on an at-home test developer describing an FDA communication that even if deficiencies were fixed, the application would be "deprioritized" (moved to the back of the line). ProPublica also reports FDA officials emphasizing sensitivity/false negatives and blaming shortages partly on lack of sustained government investment in production. ([ProPublica][13])

### 7.6 Example of FDA stopping EUA review and steering to non-EUA pathway

A 2021 report on SQI Diagnostics described FDA deciding it would not continue reviewing an EUA submission under a "tests for management of COVID-19 patients" category, citing high volume and prioritization factors, and encouraging use of a non-EUA pathway. ([Clinical Lab Products][14])

This illustrates deprioritization-like outcomes beyond classic diagnostic testing.

---

## 8) Spring/summer 2021 deprioritization vs Omicron 2022 testing shortages: what can we responsibly say?

### 8.1 The Omicron shortage was real and visible

Reuters reported (Jan 12, 2022) that long lines "snake around entire city blocks" as Americans scrambled for testing, and at-home kits flew off shelves. ([Reuters][5])

### 8.2 What the public record supports about causality

The public evidence supports a **multi-factor story**, roughly:

**A) Demand shock + planning/investment dynamics**

- ProPublica quotes FDA's CDRH director Jeff Shuren attributing differences in test availability partly to **government investment supporting production**, and describing how lack of sustained funding can make manufacturers reluctant to take on the cost/risk of the FDA process at scale. ([ProPublica][13])

**B) Regulatory triage did occur**

- FDA explicitly prioritized certain test types (at-home, POC, high-throughput, high-volume) and deprioritized others, including by closing low-priority files. ([U.S. Food and Drug Administration][1])

**C) The missing link**
What is *not* established in the public sources is a quantified counterfactual:

- "If FDA had reviewed the deprioritized EUAs in spring/summer 2021, there would have been enough additional manufacturing capacity to prevent Omicron shortages."

That could be true for some subset (especially if deprioritized submissions included would-have-scaled at-home/rapid tests), but proving it would require:

- knowing which tests were deprioritized (and why) in that period,
- knowing their realistic manufacturing ramp curves and supply chain constraints, and
- knowing whether demand-side procurement/reimbursement policies would have supported sustained production.

### 8.3 A plausible mechanism (clearly labeled as inference)

Based on FDA's own prioritization factors emphasizing **manufacturing volume** and **accessibility** ([U.S. Food and Drug Administration][1]) and GAO's documentation that FDA used "decline to review" for nonpriority tests ([Government Accountability Office][3]), one plausible mechanism is:

- If deprioritization decisions in 2021 disproportionately excluded tests that could have become high-volume at-home/rapid options by late 2021, then deprioritization could have reduced the set of suppliers going into Omicron.

But the public record also contains the countervailing point that FDA's stated priorities were precisely **at-home/POC/high-volume**, meaning many "low priority" files may not have been the ones that would materially expand at-home capacity. ([U.S. Food and Drug Administration][8])

---

## 9) What's still not publicly knowable (without FOIA / docket-level data)

Even with the above sources, several things are **not fully disclosed in public material**, including:

- A breakdown of *all* "Decline to Review" decisions by **test type**, intended setting, and month (especially the spring-summer 2021 period). GAO provides a cumulative number, not a full taxonomy. ([Government Accountability Office][3])
- The number of serology submissions "rejected or never reviewed" is explicitly described in the legal literature as not publicly disclosed. ([Food and Drug Law Institute (FDLI)][6])
- The internal scoring/weighting of prioritization factors (e.g., exactly how FDA weighed "manufacturing capacity" versus "novelty" versus "unmet need") at different pandemic phases.

---

## 10) Source map (for follow-up)

If you want to go deeper (or build a formal dossier), these are the most "load-bearing" public documents for deprioritization:

1. **FDA perspective sharing Booz Allen independent assessment** (describes triage, prioritization factors, Decline to Review/Issue, supply-chain monitoring, review tracks). ([U.S. Food and Drug Administration][1])
2. **GAO-22-104266** (quantifies declined-to-review volume; documents FDA/HHS policy moves; records stakeholder concerns). ([Government Accountability Office][3])
3. **FDA town hall transcripts** around:
   - Oct 7, 2020 (declining to review LDT EUA requests; priorities) ([U.S. Food and Drug Administration][7])
   - Mar 10, 2021 (explicit "might be deprioritized" language) ([U.S. Food and Drug Administration][2])
   - Mar 31, 2021 (phase change; focus on high-volume, accurate, needed tests) ([U.S. Food and Drug Administration][8])
   - Aug 4, 2021 (why a request was deprioritized: low capacity or deficient) ([U.S. Food and Drug Administration][9])
4. **Food and Drug Law Journal analysis (Gibbs & Javitt)** for narrative history and transparency critique, especially serology. ([Food and Drug Law Institute (FDLI)][6])
5. **Reuters (Jan 12, 2022)** as contemporaneous documentation of Omicron-era testing shortages and lines. ([Reuters][5])

[1]: https://www.fda.gov/media/152992/download "https://www.fda.gov/media/152992/download"
[2]: https://www.fda.gov/media/146811/download "https://www.fda.gov/media/146811/download"
[3]: https://www.gao.gov/assets/gao-22-104266.pdf "https://www.gao.gov/assets/gao-22-104266.pdf"
[4]: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks"
[5]: https://www.reuters.com/world/us/americans-grapple-with-prolonged-testing-woes-amid-omicron-surge-2022-01-12/ "https://www.reuters.com/world/us/americans-grapple-with-prolonged-testing-woes-amid-omicron-surge-2022-01-12/"
[6]: https://www.fdli.org/wp-content/uploads/2021/12/5-Gibbs-Javitt-Final.pdf "https://www.fdli.org/wp-content/uploads/2021/12/5-Gibbs-Javitt-Final.pdf"
[7]: https://www.fda.gov/media/143084/download "https://www.fda.gov/media/143084/download"
[8]: https://www.fda.gov/media/147394/download "https://www.fda.gov/media/147394/download"
[9]: https://www.fda.gov/media/151937/download "https://www.fda.gov/media/151937/download"
[10]: https://www.fda.gov/media/171779/download "https://www.fda.gov/media/171779/download"
[11]: https://www.thefdalawblog.com/2021/02/beware-eua-deprioritization/ "https://www.thefdalawblog.com/2021/02/beware-eua-deprioritization/"
[12]: https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process "https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process"
[13]: https://www.propublica.org/article/heres-why-rapid-covid-tests-are-so-expensive-and-hard-to-find "https://www.propublica.org/article/heres-why-rapid-covid-tests-are-so-expensive-and-hard-to-find"
[14]: https://clpmag.com/disease-states/infectious-diseases/covid-19/fda-stops-eua-review-of-sqi-covid-19-severity-triage-test/ "https://clpmag.com/disease-states/infectious-diseases/covid-19/fda-stops-eua-review-of-sqi-covid-19-severity-triage-test/"