FDA relaxes regulations for producing viral transport media required for COVID-19 tests

The FDA said manufacturers should follow standard operating procedures from the Centers for Disease Control and Prevention, updated in March to help laboratories produce their own viral transport media to help combat shortages. (FDA)

The demand for widespread COVID-19 diagnostics has strained every aspect of the enterprise, including the production of swabs, reagents and sterile containers. Now, the FDA has loosened its oversight of viral transport media, the liquid solution that keeps samples viable as they wait to be tested, in a move the agency says will help boost waning supplies.

Most of the molecular and antigen-based diagnostic tests granted emergency authorizations require some form of viral transport media or different types of sterile saline solution.

Now, the FDA is allowing commercial manufacturers to ship their products immediately, without submitting the formal, 90-day notifications typically required for a new medical device.

Featured Whitepaper

Accelerate Clinical Operations Across Sponsors, CROs, and Partners

The most advanced life sciences organizations know that digital innovation and multi-platform integrations are essential for enabling product development. New platforms are providing the life sciences industry with an opportunity to improve the efficiency of clinical trials and reduce costs while remaining compliant and reducing risk.

In addition, the agency said it does not intend to enforce its product quality system and manufacturing regulations during the coronavirus pandemic, as well as Unique Device Identifier requirements, as long as the company maintains compliance with certain ISO standards.  

RELATED: Survey details shortages of COVID-19 testing supplies and labs' responses

The FDA’s new guidance (PDF) covers certain methods of specimen collection and culture media, but does not apply to solutions designed to inactivate the virus during transport.

The document says sterile transport media should be validated by the company before distribution, to ensure that viral particles do not degrade and lead to inaccurate results. 

RELATED: FDA opens door to 'batch testing' for COVID-19 with new green lights for Quest Diagnostics

The FDA also said that manufacturers should follow the standard operating procedures outlined by the Centers for Disease Control and Prevention—updated in March to help laboratories produce their own solution to help combat shortages.

Once they have validated the use of their own product, companies are to notify the FDA by email, and the viral transport media should carry a label saying the product has not been reviewed by the FDA.

Suggested Articles

According to a large clinical study, multifocal contact lenses were able to slow down and control the worsening of nearsightedness in children.

RapidAI has secured an FDA clearance for its artificial intelligence algorithms that quickly parse brain CT scans and spot suspected strokes.

The kits can connect 20 standard hospital beds to a central patient monitoring station and be up and running in an average of five hours.