August 4, 2020

Volume X, Number 217

August 03, 2020

Subscribe to Latest Legal News and Analysis

FDA Authorizes the First Home Collection of Specimens to be Tested for COVID-19

As an update to our prior blog post, on April 20, 2020 FDA announced the authorization of the first COVID-19 test for home collection of specimens. This announcement, made via the Agency’s FAQs on Diagnostic Testing for SARS-CoV-2 webpage, comes after weeks of FDA reporting that it has been working closely with manufacturers on such a test during the weekly Virtual Town Hall Meetings hosted by the Center for Devices and Radiological Health. FDA clarifies that the test is only authorized for home collection of specimens to be sent back to a laboratory for processing. FDA still has not authorized a COVID-19 test “to be completely used and processed at home.”

According to the Emergency Use Authorization (EUA) letter for the test, the new home collection method involves the use of a nasal swab, as opposed to a nasopharyngeal swab. Home collection is only permitted “when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire.” Instructions for self-collection must be made available to individuals online or as part of the collection kit, and the kit must include materials allowing the patient to safely mail the specimen to an authorized laboratory. The letter states that the EUA will be in effect until there is a declaration that the circumstances justifying this authorization is terminated or revoked.

The home collection authorization is specific to one test, and does not authorize other manufacturers or laboratories to begin offering their own home collection kits. In its statement, FDA reminds manufacturers that any at-home test or collection kit requires an authorized EUA, whether by amendment to an existing EUA or a new request. The Agency indicates that it continues to work actively with test manufacturers in the at-home collection and testing space.

FDA’s next Virtual Town Hall Meeting on guidance related to COVID-19 diagnostic testing is scheduled for April 22, 2020 from 12:15-1:15 pm Eastern Time.

©2020 Epstein Becker & Green, P.C. All rights reserved.National Law Review, Volume X, Number 112

TRENDING LEGAL ANALYSIS


About this Author

Megan Robertson, healthcare lawyer, Epstein Becker
Associate

Megan Robertson is an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office of Epstein Becker Green. She will be focusing her practice on health care compliance, managed care, and fraud and abuse issues. 

Ms. Robertson received her J.D., with honors and with a concentration in Health Law, from The George Washington University Law School. While attending law school, she was the Executive Editor of the Federal Circuit Bar Journal and worked as a Certified Student Attorney at the school’s Vaccine Injury Litigation Clinic. She...

202-861-1835
Priya Gopalakrishnan, Epstein Becker Law Firm, Health Care Attorney
Associate

PRIYA KAULICH is an Associate in the Health Care and Life Sciences practice, in the Chicago office of Epstein Becker Green. She is also a member of the firm’s Health Employment and Labor (HEAL) strategic industry group.

Ms. Kaulich:

  • Provides advice to clients regarding the research, approval, sale, and promotion of pharmaceuticals, biologics, and medical devices

  • Advises pharmaceutical and medical device manufacturers, health care technology companies, and life sciences companies on FDA compliance matters, with a focus on current good manufacturing practices (“CGMPs”), advertising and promotion, and post-market surveillance and reporting

  • Conducts health regulatory due diligence reviews for mergers and acquisitions in the life sciences industry

  • Assists clients in drafting and negotiating clinical trial agreements and maintaining clinical research compliance

  • Advises hospitals and other health care providers on federal and state health care fraud and abuse issues, including anti-kickback and physician self-referral claims

  • Provides advice to clients on labor and employment matters in the areas of employment discrimination, wage and hour disputes, wrongful discharge, non-competition and non-solicitation agreements, and trade secrets

While attending Chicago-Kent College of Law, Ms. Kaulich served as a Notes & Comments Editor of the Chicago-Kent Law Review. She also served as a Legal Intern for a large multinational medical device manufacturer, where she focused on health care regulatory, compliance, and transactional matters, with an emphasis on third-party payer requirements for suppliers of durable medical equipment.

312-499-1433