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.
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.
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.
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.