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# Verax Asks FDA Not to Take ‘Arbitrary’ Action
- URL: https://www.fdaweb.com/verax-asks-fda-not-to-take-arbitrary-action/
- Published: 2019-12-10T12:00:00.000Z
- Updated: 2026-09-14T15:56:08.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5145695

Verax Biomedical is asking that FDA: 

- refrain from clearing, approving, recommending, or issuing a “safety measure” designation for large volume delayed sampling (LVDS) as a single step bacterial culture technology for dating beyond Day 5 without first obtaining statistically conclusive data supporting the safety and effectiveness from clinical evidence on apheresis platelets demonstrating that the LVDS method is effective at preventing the transfusion of bacterially contaminated blood platelets by Day 5;
- refrain from clearing, approving, recommending, or issuing a “safety measure” designation for any other platelet contamination detection method, storage device or method, or pathogen reduction method without statistically conclusive data supporting the safety and effectiveness from clinical evidence on apheresis platelets demonstrating that the technology or methodology is effective at preventing the transfusion of bacterially contaminated blood platelets; and
- refrain from clearing, approving, recommending, or designating as a “safety measure” any technologies or methodologies without statistically conclusive data supporting the safety and effectiveness of the technologies or methodologies.

Verax [says](https://www.regulations.gov/contentStreamer?documentId=FDA-2019-P-5800-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) it also wants FDA to “apply consistent regulatory standards and precedents in reviewing data in support of such products or expanded claims.” It reminds the agency that a court will set aside an agency action when the action is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.