METADATA
last updated: 2026-03-01 AI
file_name: _AI_COVID19_LDTs_FDA_Policy_Report.md
file_date: 2026-03-01
title: FDA, LDTs, and COVID-19: Interactions, Policy Shifts, and Key Issues (2020-2023)
category: regulatory
subcategory: ldts
tags: ldts, fda, covid-19, eua, laboratory-developed-tests, enforcement-discretion
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license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
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notes: Created by ChatGPT Pro 5.2 Extended during archive preparation. **NOT HUMAN VERIFIED - MAY CONTAIN ERRORS** Detailed analysis of FDA policy actions, enforcement discretion shifts, and LDT oversight during COVID-19 (2020-2023), synthesizing GAO-22-104266, FDA COVID test policy guidance (7th edition), HHS rescission statements, and CDC LOCS alerts. Prompt not included.
summary_short: FDA, LDTs, and COVID-19 policy analysis covering three phases of LDT oversight during the pandemic: initial EUA-based enforcement discretion (early 2020), HHS blocking mandatory premarket review (Aug 2020-Nov 2021), and FDA's restoration of EUA-first posture (Nov 2021-2023). Includes detailed timeline, document index, and quantitative markers drawn primarily from GAO-22-104266 and FDA policy guidance.


CONTENT

***INTERNAL TITLE:*** FDA, LDTs, and COVID-19: Interactions, Policy Shifts, and Key Issues (2020-2023)

**Time window covered:** January 2020 - May 2023 (plus key transition guidance issued during the PHE through March 2023)

**Scope note:**  
This report is narrowly focused on **COVID-19-era** interactions, guidance, enforcement policies, and disputes involving **laboratory-developed tests (LDTs)** and **FDA oversight**. It intentionally **does not repeat** (1) pre-pandemic LDT regulatory history or (2) the post-pandemic 2024 LDT Final Rule and later litigation that is covered in separate archive documents.

---

## Table of contents

1. What changed during COVID (executive overview)  
2. Key terms and why “LDT vs FDA-authorized” mattered in practice  
3. COVID-era policy mechanisms that shaped LDT oversight  
4. Detailed timeline of policy actions (with “what changed” and “why it mattered”)  
5. The major issues and disputes (quality, access, liability, payer acceptance, federal–state roles)  
6. COVID-era document index (date, issuer, action, link)  
7. Appendix: structured timeline table + key quantitative markers

---

## 1. What changed during COVID (executive overview)

Across the COVID-19 period, the LDT/FDA relationship moved through three distinct phases—each with a different answer to “*Does a COVID LDT need FDA authorization?*”

### Phase A — Early pandemic expansion with guardrails (Feb–Mar 2020)
- **FDA’s operational posture:** FDA expected COVID-19 diagnostic LDTs to pursue **EUA authorization**, but used **enforcement discretion** to let certain labs start testing **before** authorization if they validated, notified FDA, and submitted an EUA request on a defined timeline.  
- **Key artifact:** FDA created **notification lists** to track tests being used while EUA review was pending.

### Phase B — HHS blocks mandatory FDA premarket review; FDA declines LDT EUA reviews (Aug–Oct 2020 → late 2021)
- **HHS action (Aug 19, 2020):** HHS stated FDA **“will not require premarket review”** of LDTs without notice-and-comment rulemaking, even during COVID-19.  
- **FDA follow-on (Oct 2020):** FDA posted an FAQ indicating it was **declining to review** EUA requests for LDTs “at this time,” and CDC communicated this shift to laboratories.

### Phase C — HHS reverses; FDA rebuilds EUA-first posture and unwinds notification-list model (Nov 2021 → 2023)
- **HHS action (Nov 15, 2021):** HHS withdrew the 2020 policy, restoring FDA’s prior authority/approach.  
- **FDA action (Nov 15, 2021 and later editions):** FDA issued revised COVID test policy guidance, generally expecting tests (including LDTs) to have EUA authorization before being offered, and took steps to **reduce unauthorized tests** remaining on notification lists.

**High-level impact:**  
COVID forced repeated changes in what “LDT vs FDA-authorized test” meant in real-world terms—affecting **validation expectations, use environments (CLIA constraints), liability and PREP Act coverage messaging, payer/contracting acceptance, and FDA’s ability to intervene** when tests performed poorly.

---

## 2. Key terms (COVID-era operational definitions)

### 2.1 What the government meant by “LDT” during COVID
Across federal documents summarized below, an LDT is generally treated as an in vitro diagnostic test that is:

- **designed, manufactured, and used within a single laboratory**, and  
- performed within a lab certified under **CLIA** that meets **high-complexity** testing requirements.

FDA and GAO also highlight boundary issues:
- FDA does **not** consider a test an LDT if it is designed/manufactured wholly or partly outside the lab that offers it.  
- FDA officials told GAO that tests developed by **large multistate lab networks** can be treated as **commercial** tests if distributed to multiple labs in a network.

### 2.2 EUA-authorized vs “unauthorized but tolerated”
- **EUA-authorized test:** FDA has issued an EUA; the product is subject to conditions of authorization and becomes an official “authorized” countermeasure.  
- **Unauthorized but tolerated test:** Offered under FDA’s enforcement discretion policies (early pandemic), under state/territory authorization (early pandemic), or as an LDT offered without EUA during the Aug 2020–Nov 2021 HHS policy period.

---

## 3. Policy mechanisms that shaped COVID-19 LDT oversight

### 3.1 EUA declaration: the legal trigger tying policy to emergency powers
FDA’s COVID test policy documents explicitly tie their duration and framework to the HHS Secretary’s **February 4, 2020** declaration under FD&C Act §564 for IVDs related to COVID-19. (FDA policy guidance cites 85 FR 7316 for the declaration.)

### 3.2 Enforcement discretion “lanes” to scale testing quickly
To expand capacity rapidly, FDA used enforcement discretion so that certain tests could be distributed/offered **before** EUA issuance. For LDTs, early discretion applied to **high-complexity CLIA labs** developing tests for use in their own lab.

### 3.3 Notification lists: a COVID-era operational bridge between “unauthorized” and “authorized”
GAO reports FDA maintained **four notification lists**: diagnostic LDTs, antibody LDTs, diagnostic commercial tests, and antibody commercial tests. Tests could remain on these lists while FDA reviewed EUA requests.

### 3.4 State/territory authorization option (March 2020 policy)
FDA created a policy for states/territories to authorize labs within their borders to develop and use COVID tests without EUA submission to FDA. GAO reports eight states and Puerto Rico notified FDA of intent to do this; six states authorized labs and used FDA guidance as they built review processes.

### 3.5 Continuous interaction channels: pre‑EUA, templates, and Town Halls
GAO documents several mechanisms that functioned as “interaction infrastructure” between FDA and test developers:
- **EUA templates** (available by request in January 2020; posted Feb 29, 2020; eight templates on website by Nov 2021).  
- **Pre‑EUA process** (GAO reports 1,275 pre‑EUA requests for COVID tests Jan 2020–Sep 2021).  
- **Weekly/biweekly public Town Hall calls** (beginning March 25, 2020; GAO reports 70 town halls held by Sept 30, 2021).

---

## 4. Detailed timeline of LDT–FDA policy actions during COVID-19

### Legend
Each timeline entry is presented as:
- **Date**
- **Actor / venue**
- **Action / document**
- **What changed for LDTs vs FDA-authorized tests**
- **Why it mattered (issues / controversy)**

---

### 4.1 January–February 2020: emergency declarations and EUA authority

#### Jan 31, 2020 — HHS public health emergency (PHS Act §319)
- **Actor:** HHS  
- **Action:** Declared a public health emergency related to COVID-19; mobilized HHS operating divisions.  
- **Why it mattered:** Establishes the emergency context referenced in later FDA policy background.

#### Feb 4, 2020 — HHS EUA declaration for COVID IVDs (FD&C Act §564)
- **Actor:** HHS  
- **Action:** Declared circumstances exist justifying EUA issuance for COVID-related in vitro diagnostics.  
- **Why it mattered for LDTs:** During declared emergencies, FDA historically did **not** apply broad LDT enforcement discretion; this set up the later tension between “normal LDT discretion” and emergency oversight.

**Primary anchor:** FDA COVID test policy guidance (7th edition, Jan 12, 2023) + referenced Federal Register citation.

---

### 4.2 Feb 29, 2020: FDA opens a rapid diagnostic LDT pathway (validate → notify → file EUA)

#### Feb 29, 2020 — FDA enforcement discretion policy for diagnostic LDTs
- **Actor:** FDA  
- **Action (as summarized by GAO):** FDA said it did not intend to object to high‑complexity CLIA labs using validated diagnostic LDTs **prior to authorization**, as long as labs (1) validated, (2) notified FDA, and (3) submitted an EUA request within **15 business days** after notification.  
- **LDT vs FDA-authorized distinction at this point:** LDTs could be used *temporarily* without EUA, but EUA submission remained the expected endpoint.  
- **Operational detail:** After notification, FDA placed tests on a “notification list.”

**Why it mattered:**  
This policy was meant to increase testing capacity rapidly while still channeling tests toward EUA authorization as the durability/credibility step.

**Source:** GAO narrative and Appendix II.

---

### 4.3 March 16, 2020: FDA expands the model (commercial tests), adds serology flexibility, and decentralizes via states

#### March 16, 2020 — Commercial diagnostic test enforcement discretion lane
- **Actor:** FDA  
- **Action (GAO):** Similar “validate → notify → submit EUA within 15 business days” lane extended to commercial diagnostic tests; FDA later clarified use was limited to high‑complexity CLIA labs unless an EUA expanded environments.  
- **Why it mattered:** Enlarged the pool of tests available quickly, but increased the volume of “unauthorized but tolerated” tests awaiting review.

#### March 16, 2020 — Antibody/serology policy (initially no EUA expected)
- **Actor:** FDA  
- **Action (GAO):** FDA initially did not expect antibody test developers (including laboratories) to seek EUA if they validated, notified FDA, and included specific disclaimers in reports.  
- **Why it mattered:** This permissive approach led to the “serology flood” problem—an important cautionary example used in later policy debates about whether LDT oversight should be loosened or tightened during emergencies.

#### March 16, 2020 — State/territory authorization policy for LDTs
- **Actor:** FDA  
- **Action (GAO):** FDA said it did not intend to object to states/territories authorizing laboratories within their jurisdiction to develop and use COVID-19 LDTs without EUA submission to FDA.  
- **Documented uptake:** GAO reports **eight states and Puerto Rico** notified FDA; six states authorized laboratories; and those states used FDA guidance in building review processes. GAO reports that as of April 2021 those six states had authorized **91 laboratories** that developed **121 molecular tests**, and **19 laboratories** that developed **23 antibody tests**.

**Why it mattered:**  
Created a meaningful alternative to FDA EUA review, but with the tradeoff of unevenness and questions about standardization and accountability.

**Source:** GAO narrative.

---

### 4.4 April–May 2020: serology quality concerns drive tightening

#### April 2020 — Interagency serology evaluation collaborations
- **Actor:** FDA + NCI + NIAID + CDC + BARDA  
- **Action (GAO):** Partnered to evaluate antibody test performance to inform authorization decisions and address market quality concerns.

#### May 4, 2020 — FDA tightens antibody test pathway
- **Actor:** FDA  
- **Action (GAO):** FDA revised policy to expect commercial manufacturers of antibody tests to submit EUA requests within **10 business days** (labs encouraged but not required).  
- **Market cleanup:** GAO reports FDA removed **268** commercially developed antibody tests from its notification list as of July 30, 2021 when manufacturers did not submit an EUA within the deadline or did not address significant problems in time.

**Why it mattered:**  
This is a core “policy learning” moment: loosening premarket oversight can expand availability fast, but can also flood the market with weak tests—inviting later tightening.

**Source:** GAO narrative and Appendix II.

---

### 4.5 Aug–Oct 2020: HHS blocks mandatory FDA premarket review; FDA declines to review LDT EUA submissions

#### Aug 19, 2020 — HHS web statement limiting FDA premarket review of LDTs
- **Actor:** HHS  
- **Document:** “Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests” (HHS web statement; archived copy).  
- **Key language (short excerpt, <25 words):** HHS determined FDA “**will not require premarket review**” of LDTs absent “**notice-and-comment rulemaking**.”  
- **Additional HHS points (paraphrased):**
  - EUA/510(k)/PMA submissions for LDTs could be made **voluntarily**, and FDA would adjudicate.  
  - LDTs used without FDA review would not be eligible for **PREP Act coverage** absent approval/clearance/authorization, and would remain regulated under **CLIA/CMS**.  
  - Active EUAs for COVID-19 LDTs were unaffected.

**Why it mattered:**  
This reversed the early COVID posture that treated EUA as the expected requirement for COVID LDTs and created a period where “LDT without EUA” was legally permissible under the federal executive branch’s stated position.

**Primary source:** archived HHS statement PDF.

#### Oct 7, 2020 — FDA posts FAQ: “declining to review EUA requests for LDTs”
- **Actor:** FDA  
- **Action:** FDA posted an FAQ clarifying review priorities and stating it was “declining to review EUA requests for LDTs at this time.”

#### Oct 9, 2020 — CDC LOCS lab alert: communicates the shift
- **Actor:** CDC (LOCS)  
- **Document:** “Lab Alert: FDA Suspends Review of EUA Requests for Laboratory-Developed Tests for SARS-CoV-2”  
- **Key point:** In alignment with the HHS announcement, FDA “will not review EUA requests for any LDTs at this time,” and CDC directs labs to FDA FAQs and HHS FAQs resources.

**Why it mattered / issues flagged:**  
GAO reports lab associations described confusion and uncertainty—particularly around payer expectations and PREP Act liability protection for LDTs without EUA authorization.

**Sources:** CDC LOCS alert; GAO text box on LDT EUA policy changes.

---

### 4.6 2021: FDA review prioritization, screening focus, and the lead-up to reversal

#### March 16, 2021 — FDA streamlining path for serial screening tools (including at-home/OTC)
- **Actor:** FDA  
- **Action (GAO Appendix II):** FDA announced steps to streamline authorization for serial screening of asymptomatic individuals, including at-home and OTC tests.  
- **Why it matters for LDT policy:** Shows FDA’s emphasis on resource allocation and public-health impact in deciding what to prioritize for EUA review.

#### 2020–Sep 2021: “decline to review” as an operational lever
- **Actor:** FDA  
- **Action (GAO):** FDA prioritized EUA review for tests that increased accessibility (POC, home collection, at-home) or capacity (high throughput, supply-sparing). GAO reports that as of Sept 30, 2021 FDA had declined to review **558** EUA requests, including **230 LDTs**.  
- **Why it mattered:** Even where EUA submission could be “voluntary” (Aug 2020–Nov 2021), FDA’s decision to decline review functionally shaped the market.

**Source:** GAO narrative.

---

### 4.7 Nov 15, 2021: HHS withdraws the 2020 policy; FDA issues revised COVID tests policy and begins unwinding notification lists

#### Nov 15, 2021 — HHS withdrawal of the Aug 2020 policy
- **Actor:** HHS  
- **Action (GAO Appendix II):** Withdrew the August 2020 policy, thereby reinstating FDA’s approach to regulating COVID-19 LDTs.  
- **Stated rationale (as widely reported):** The 2020 policy “limited FDA’s ability to address certain problematic COVID-19 tests.”

**Sources:** GAO Appendix II; JAMA commentary discussing the withdrawal rationale.

#### Nov 15, 2021 — FDA revised COVID tests policy (key LDT-relevant elements, per GAO)
GAO summarizes that FDA’s updated guidance:
- generally expected COVID tests to have EUA authorization before being offered;  
- would no longer add commercial or LDT tests to notification lists;  
- would no longer apply the March 2020 state authorization policy to **additional** states/territories; and  
- expected labs offering LDTs without EUA submissions to submit an EUA request within **60 calendar days** or cease marketing/offering (GAO summary).

**Why it mattered:**  
This was a decisive move away from the early-pandemic “notify and list” model, driven by concerns that tests remained available for months without full review.

**Source:** GAO Appendix II; GAO discussion of notification list durations and risks.

---

### 4.8 2022–Jan 2023: continued EUA-first posture, with clarifications for legacy pathways

#### Notification list persistence and the November 2021 “phase down”
GAO quantifies why FDA intervened:
- In June 2021, the longest commercial antibody test stayed on a notification list **359 days** before FDA declined authorization.  
- GAO found 65% of commercial diagnostic tests on notification lists in Nov 2021 had been listed for **at least a year**.  
- As of April 8, 2022, GAO reports **68 tests remained** on notification lists, including **26** lab-developed diagnostic tests and **25** lab-developed antibody tests.

FDA’s Nov 2021 policy sought to reduce this backlog and phase the lists out.

**Source:** GAO narrative.

#### Jan 12, 2023 — FDA issues 7th edition COVID test policy (within the EUA declaration period)
- **Actor:** FDA  
- **Document:** “Policy for Coronavirus Disease-2019 Tests (Revised)” (7th edition; supersedes Sep 27, 2022 edition)  
- **Notable LDT-specific clarifications:**
  1) **State/territory authorization narrowed:**  
     FDA reiterates it no longer intends to extend the state policy to new states/territories. For states/territories already listed before Nov 15, 2021 and continuing to authorize labs, FDA does not intend to object where the state/territory takes responsibility—limited to single-site high-complexity CLIA labs and excluding at-home/home collection tests.  
  2) **Handling of certain “legacy” LDTs tied to the Aug 2020–Nov 2021 period:**  
     FDA does not intend to object to continued distribution while FDA reviews EUA requests for (a) tests on notification lists and (b) certain LDTs offered during the Aug 2020–Nov 2021 window where an EUA request was later submitted per the Nov 2021 approach. If FDA declines to review/authorize, it generally expects cessation within **15 calendar days**.

**Why it mattered:**  
This edition shows how FDA operationalized the “reasserted authority” phase: keeping limited accommodation for tests already in motion, while reinforcing EUA-first expectations.

**Source:** FDA policy guidance (Jan 12, 2023).

---

### 4.9 March–May 2023: transition planning as the PHE ended

#### March 27, 2023 — FDA EUA transition plan (final guidance)
- **Actor:** FDA  
- **Document:** “Transition Plan for Medical Devices Issued EUAs Related to COVID-19”  
- **LDT-specific statement (paraphrased):** FDA generally exercises enforcement discretion for LDTs, but did not apply that discretion to LDTs used for declared emergencies under §564; **after termination of the EUA declaration for COVID IVDs, FDA intends to treat COVID-19 LDTs like other LDTs**.

**Why it mattered:**  
Signals that COVID-era heightened oversight of LDTs was tied to the EUA declaration; once EUA authority ends, the default LDT enforcement approach returns.

**Source:** FDA transition plan guidance (Mar 27, 2023).

#### May 11, 2023 — COVID-19 PHE expires (PHS Act §319)
- **Actor:** HHS (PHE expiration) + FDA communications  
- **FDA summary (as of Nov 8, 2023 update):** Enforcement policy guidances tied to the PHE (within scope of FDA’s transition plan for enforcement policies) are no longer in effect; **existing EUAs remain in effect** under FD&C Act §564 until EUA declarations terminate.

**Source:** FDA SARS-CoV-2 testing FAQs page.

---

## 5. The major issues and disputes during COVID (as reflected in government reporting and policy pivots)

### 5.1 Access vs oversight: the “speed–quality” balancing act
- **Access pressure:** Early in the pandemic, stakeholders told GAO that EUA processes may have stymied scaling when testing capacity was limited; some would have preferred FDA not object to LDT use without EUA sooner.  
- **Oversight pressure:** FDA officials emphasized that poorly performing tests could undermine emergency response; the serology episode became a vivid case for tightening.

### 5.2 Serology: a cautionary example that shaped broader policy attitudes
GAO highlights that poorly performing or fraudulent antibody tests flooded the market under early permissive policy, prompting:
- May 4, 2020 tightening,  
- interagency performance evaluations, and  
- large-scale removals from notification lists.

This event became a reference point for arguments that “flexibility without robust validation” has real downstream harms.

### 5.3 Policy whiplash and market confusion (Aug 2020–Nov 2021)
This period created unusual uncertainty because:
- HHS said FDA could not require premarket review of LDTs (including EUA),  
- FDA later declined to review LDT EUA submissions, and  
- market actors (payers, employers, institutions) could still insist on “FDA-authorized” status.

GAO reports lab associations flagged confusion particularly around **insurance coverage and PREP Act liability protections** for LDTs without EUA.

### 5.4 Notification lists: the risk of “unauthorized tests” remaining in use for long durations
GAO documents that tests sometimes remained on notification lists for months (or a year+), meaning:
- tests could be used widely before FDA completed full EUA review, and  
- some flaws might not be uncovered until full review (e.g., use of contrived samples vs live viral samples).

This motivated the Nov 2021 policy to phase down notification lists and force reconfirmation for pending EUA submissions.

### 5.5 Federal–state role tension: state authorization as capacity tool vs standardization challenge
The state authorization pathway was intended to accelerate capacity; GAO reports uptake and significant numbers of state-authorized tests.  
But FDA later limited expansion, reflecting a shift toward standardization and FDA-centered review as the pandemic evolved.

---

## 6. Document index: key COVID-era primary sources and where they fit

| Date | Issuer | Document / venue | Type | Direct relevance to LDT vs EUA issues |
|---|---|---|---|---|
| Jan 31, 2020 | HHS | §319 public health emergency declaration (referenced in FDA policy background) | Declaration | Emergency context |
| Feb 4, 2020 | HHS | §564 EUA declaration for COVID IVDs (85 FR 7316 ref in FDA policy) | Declaration | Legal trigger for COVID IVD EUAs |
| Feb 29, 2020 | FDA | COVID test policy (1st edition) | Guidance | Diagnostic LDTs: validate/notify + EUA within 15 business days |
| Mar 16, 2020 | FDA | COVID test policy revision | Guidance | Expands to commercial tests; creates state authorization; permissive serology policy |
| May 4, 2020 | FDA | COVID test policy revision | Guidance | Tightens serology; EUA expected for commercial antibody tests |
| Aug 19, 2020 | HHS | “Rescission of Guidances…” | Web statement | FDA cannot require premarket review of LDTs absent rulemaking; PREP Act messaging |
| Oct 7–9, 2020 | FDA / CDC | FDA FAQ language + CDC LOCS lab alert | FAQ / Lab alert | FDA declines to review EUA requests for LDTs “at this time” |
| Mar 16, 2021 | FDA | FDA press statement on screening tools | Press statement | Streamlining EUA path for serial screening (including at-home/OTC) |
| Nov 15, 2021 | HHS / FDA | HHS withdrawal + FDA revised policy | Statement + Guidance | Restores FDA approach; unwinds notification lists; deadlines for EUA submissions |
| Jan 12, 2023 | FDA | “Policy for Coronavirus Disease‑2019 Tests (Revised)” | Guidance | Clarifies state policy (only existing states); legacy tests; cease within 15 days if declined |
| Mar 27, 2023 | FDA | EUA transition plan guidance | Guidance | COVID LDTs revert to general LDT enforcement approach after EUA declaration ends |
| May 11, 2023 | HHS / FDA | PHE expiration + transition communications | Milestone | Ends PHE-era enforcement policies; EUAs remain until EUA declarations end |
| | | | | |

---

## 7. Appendix A — Structured timeline table (condensed)

> This table is designed for quick scanning. The detailed narrative above is the “full text” record.

| Date | Action | Key LDT vs EUA implication |
|---|---|---|
| Jan 31, 2020 | HHS §319 PHE declared | Emergency conditions established |
| Feb 4, 2020 | HHS §564 EUA declaration for COVID IVDs | EUA pathway activated for diagnostics |
| Feb 29, 2020 | FDA enforcement discretion for diagnostic LDTs | LDTs may be used before EUA if validated/notified; EUA expected soon |
| Mar 16, 2020 | FDA expands to commercial tests + serology + state authorization | Multiple “pre‑EUA” lanes; states can authorize LDTs |
| May 4, 2020 | FDA tightens serology oversight | EUA expected for commercial serology; market cleanup begins |
| Aug 19, 2020 | HHS blocks mandatory FDA premarket review of LDTs | LDTs not required to submit EUA absent rulemaking; PREP Act messaging |
| Oct 7–9, 2020 | FDA declines LDT EUA reviews; CDC alerts labs | “Voluntary EUA” becomes uncertain; LDT authorization signal weakened |
| Mar 16, 2021 | FDA focuses on screening/serial testing authorizations | Review prioritization becomes central |
| Nov 15, 2021 | HHS withdraws Aug 2020 policy; FDA revises guidance | EUA-first posture restored; notification lists phased down |
| Jan 12, 2023 | FDA clarifies state policy and legacy tests | Existing state pathway only; “stop within 15 days” if declined |
| Mar 27, 2023 | FDA issues EUA transition plan | COVID LDTs revert to general LDT approach after EUA declaration ends |
| May 11, 2023 | PHE ends | PHE-related enforcement guidances end; EUAs continue |
| | | |

---

## 8. Appendix B — Quantitative markers and documented operational facts

These data points are useful “anchor facts” when describing the scale and operational impact of policies.

- **State authorization uptake:** Eight states + Puerto Rico notified FDA; six states authorized labs; by April 2021 those six states authorized 91 labs with 121 molecular tests and 19 labs with 23 antibody tests. *(GAO)*  
- **Pre‑EUA engagement:** 1,275 pre‑EUA requests (Jan 2020–Sep 2021). *(GAO)*  
- **Town Halls:** 70 town halls for test developers held by Sept 30, 2021 (began March 25, 2020). *(GAO)*  
- **“Decline to review” scale:** As of Sept 30, 2021, FDA declined to review 558 EUA requests, including 230 LDTs. *(GAO)*  
- **Notification list persistence:** In June 2021, the longest commercial antibody test was on a notification list 359 days; 65% of commercial diagnostic tests on notification list in Nov 2021 had been listed for at least a year. *(GAO)*  
- **Notification list size after phase-down:** As of April 8, 2022, 68 tests remained on notification lists, including 26 lab-developed diagnostic tests and 25 lab-developed antibody tests. *(GAO)*  
- **Serology removals:** As of July 30, 2021, FDA had removed 268 commercial antibody tests from the notification list. *(GAO)*

---

## 9. Source list and direct links

### Primary / authoritative sources (recommended for citation)
1. **GAO (May 2022):** *COVID‑19: FDA Took Steps to Help Make Tests Available; Policy for Future Public Health Emergencies Needed (GAO‑22‑104266)*  
   PDF: https://www.gao.gov/assets/gao-22-104266.pdf

2. **FDA (Jan 12, 2023):** *Policy for Coronavirus Disease‑2019 Tests (Revised) — Guidance for Developers and FDA Staff*  
   PDF: https://www.fda.gov/media/135659/download

3. **HHS (Aug 19, 2020; archived copy):** *Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests*  
   Archived PDF copy: https://www.thefdalawblog.com/wp-content/uploads/2021/11/HHS-Statement.pdf

4. **CDC LOCS (Oct 9, 2020):** *Lab Alert: FDA Suspends Review of EUA Requests for Laboratory‑Developed Tests for SARS‑CoV‑2*  
   https://www.cdc.gov/locs/2020/fda_suspends_review_of_eua_requests_for_lab_developed_tests_for_SARS-CoV-2.html

5. **FDA (Mar 27, 2023):** *Transition Plan for Medical Devices Issued EUAs Related to COVID‑19*  
   PDF: https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/FDA/COVID-Transition-EUA-Guidance.pdf

6. **FDA (FAQs updated Nov 8, 2023):** *FAQs on Testing for SARS‑CoV‑2*  
   https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2

### High-quality secondary synthesis (useful for interpreting controversies)
7. **JAMA (Mar 4, 2022):** *SARS‑CoV‑2 Laboratory‑Developed Tests: Integrity Restored*  
   https://jamanetwork.com/journals/jama/fullarticle/2789917

8. **Ropes & Gray (Aug 24, 2020):** *HHS Prohibits FDA from Requiring Premarket Review of LDTs, Including During the COVID‑19 Emergency*  
   https://www.ropesgray.com/en/insights/alerts/2020/08/hhs-prohibits-fda-from-requiring-premarket-review-of-ldts-including-during-the-covid-19-emergency

---

## 10. Notes on how this report fits the FloodLAMP archive

- **Pre-pandemic background:** See the JD Supra / Skadden overview article (included in this archive subcategory).  
- **Post-pandemic rule/litigation:** See the separate document on the 2024 LDT Final Rule and subsequent legal history.

---

*This report is an evidence-oriented synthesis of dated policy actions and is not legal advice.*