The Food and Drug Administration (FDA) is removing the regulation requiring a specified test for the presence of Mycoplasma for live virus vaccines produced from in vitro living cell cultures and inactivated virus vaccines produced from such living cell cultures. This regulation is overly restrictive in that it identifies only one test method in detail to be used even though other methods also may be appropriate. More sensitive and specific methods exist and are currently being practiced. Removal of the required test for Mycoplasma provides flexibility for accommodating new and evolving technology and capabilities without diminishing public health protections.

This Final Regulatory Impact Analysis discusses the economic impacts of the rule, including potential costs, cost savings, and benefits. Because manufacturers already have the ability to pursue alternative Mycoplasma testing procedures, FDA anticipates no measurable change in behavior from this rulemaking. While the rule may produce some unquantifiable efficiencies by increasing flexibility, it will produce no quantifiable costs, cost savings, or benefits.

Regulatory Impact Analysis

Revocation of the Test for Mycoplasma Document (PDF - 110KB)

Federal Register: 85 FR 51635, August 21, 2020

Docket: FDA-2018-N-4757