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last updated: 2026-03-05 by BA
file_name: Memo - Surveillance Authority Plain-language Research (Jan 2021 from Senior Medical Director in Healthcare Industry).md
file_date: 2021-01-11
title: Memo - Surveillance Authority Plain-language Research (Jan 2021 from Senior Medical Director in Healthcare Industry)
category: regulatory
subcategory: surveillance
tags:
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summary_short: The plain-language CMS/FDA overview summarizes how “surveillance” COVID-19 testing is described in FDA guidance as population-level monitoring that FDA generally does not regulate, and explains conditions under which individual results may be returned if presumptive positives are routed to confirmatory testing in a CLIA-certified laboratory. It also cites CMS’s temporary enforcement discretion under CLIA for certain SARS-CoV-2 surveillance testing workflows, especially where non-CLIA facilities do not report definitive results but instead refer presumptive positives or inconclusives to a CLIA lab. It frames these points as a non-legal explanatory digest of agency guidance and notes that public health authorities may have additional powers to support population safety efforts.


CONTENT

## Plain Language Overview of CMS, FDA regulations and current guidance.
(This is not intended as legal advice. Rather - this is a simple plain-language explanation of currently available documents from FDA and CMS. No reader of this document should construe it as legal advice, or a suggestion that any methods described are reasonable, appropriate or legal.)

A 'surveillance' program with validation of results with a CLIA laboratory:

Surveillance testing is explicitly NOT regulated by the FDA ([cite](https://www.fda.gov/media/137599/download) and [cite](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/pooled-sample-testing-and-screening-testing-covid-19)). While surveillance testing typically does not permit the return of individual results, they are no longer enforcing this rule as long as positive results are sent to a CLIA laboratory. In addition, there is significant legal history that empowers public health authorities to protect the health and welfare of citizens.

The FDA defines a range of types of tests. Surveillance, Screening and Diagnostic testing. They are described here: [FDA on types of testing](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2#general-differences).

Surveillance testing is primarily used to gain information at a population level, rather than an individual level. Surveillance testing may be random sampling of a certain percentage of a specific population to monitor for increasing or decreasing prevalence and determining the population effect from community interventions such as social distancing. FDA generally does not regulate surveillance testing.


## Regulation and oversight of surveillance testing
Surveillance tests do NOT need to be approved by the FDA or used in a CLIA setting. [FDA on types of testing](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2#general-differences)

A: The FDA does not generally regulate the use of a test for surveillance purposes, such as determining the prevalence of acute infections in a population. The FDA understands that results have been returned to individuals tested for COVID-19 surveillance purposes. If surveillance testing is performed by a non-CLIA certified laboratory, an individual who tests positive for SARS-CoV-2 should have a confirmatory test performed by a CLIA-certified laboratory. Surveillance with return of results and surveillance with pooled or batched testing should be validated on a test platform and test of high sensitivity and positive tests should have a confirmatory test.

CMS further indicates [here](https://www.cms.gov/files/document/clia-university-lab-testing-8/28/2020.pdf):

However, CMS is temporarily exercising enforcement discretion under CLIA for SARS-CoV-2 surveillance testing where patient-specific results are reported (e.g., SARS-CoV-2 surveillance testing that does not utilize a pooling strategy).

Specifically, neither CMS nor the State survey agencies on its behalf will non-CLIA certified facilities, such as university laboratories, that are performing such testing, provided that the facility does not report actual test results, but only refers an individual with a presumptive positive or inconclusive test result to a CLIA-certified laboratory for further testing.


## Public health authorities
Public health authorities have additional powers to ensure the safety of populations. Some discussion of this [here](https://www.cdc.gov/eis/field-epi-manual/chapters/Legal.html).