A recent USA Today article concerning the distribution of at-home coronavirus testing kits highlighted the confusion over what testing kits the FDA finds to be acceptable in the marketplace. COVID-19 test kits, while valuable today, are devices that have a defined regulatory pathway at FDA. COVID-19 test kits for in-the-home use are a great concept, but they are unapproved until they go through the proper FDA channels. There is also the issue of whether the FDA currently finds at-home testing kits acceptable.
Currently, there is an Emergency Use Authorization of diagnostic COVID-19 test kits performed at laboratories. The ones approved have involved RT-PCR for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (swabs, sputum, aspirates, bronchoalveolar lavage, and nasopharyngeal washes). The FDA is also accepting COVID-19 diagnostic kits for other specimens collected.
The rules are clear, and the FDA is enforcing when those rules are being broken. The Agency began monitoring the marketplace for firms marketing diagnostic test kits designed for end-users to test themselves at home. FDA released a public statement on March 20 regarding these test kits. A major consideration in marketing these kits is validation. Manufacturers of unapproved products typically lack critical validation studies before being sold in the market. The decision to release a product without FDA approval or validation studies creates confusion and noise in the marketplace when the current health care crisis needs a clear signal.
Don’t make headlines for being mentioned in an FDA device warning letter. If your business is looking to support this crisis, KGK can help with Emergency Use Authorization device submissions to FDA. Contact us today with your questions.
Corey Hilmas, MD, PhD
Chief Regulatory Officer, KGK Science