FDA Considering Self-Collection Sample Regulation

The U.S. Food and Drug Administration (FDA) may be considering selfcollection of samples for cervical cancer screening. The agency is seeking guidance on the evaluation of cervical sample self-collection devices for cervical cancer screening of patients, according to a Sept. 8 announcement in the Federal Register. But experts say that FDA’s consideration of selfcollection devices could have broader implications for over-the-counter testing than just for cervical cancer screening. The announcement says the FDA will hold a public workshop entitled ”Self- Collection Devices for Pap Test" on Jan. 11, 2018. Additionally, the agency is collecting comments comment until Feb. 14, 2018. The agency says the goal of the workshop is to gather feedback about the feasibility, benefits, risks, current attitude, and impact on current standard of care of potential selfcollection of cervical cancer screening samples, as well as regulatory and validation considerations. "The implications of the public workshop potentially go well beyond the field of cervical screening." —Jeffry Gibbs,Hyman, Phelps &McNamara Regular screening and early detection of human papillomavirus (HPV), especially high-risk strains HPV16 and 18, can prevent cervical cancer. Routine Pap testing has been heralded as a success in decreasing the incidence of cervical cancer. Yet, screening gaps exist. Known […]