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Self-Collection Devices for Pap Test; Public Workshop; Request for Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Self-Collection Devices for Pap Test.'' The purpose of the publi...

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Self-Collection Devices for Pap Test.'' The purpose of the public workshop is to obtain feedback about the feasibility, benefits, risks, impact on current standard of care, and least burdensome validation approaches for self- collection devices for cervical samples for the purpose of cervical cancer screening by Pap testing. Comments and suggestions generated through this workshop will guide the development of an appropriate least burdensome regulatory framework for the evaluation of cervical sample self-collection devices to be used for cervical cancer screening of patients.

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82 FR 42557

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“Self-Collection Devices for Pap Test; Public Workshop; Request for Comments,” thefederalregister.org (September 8, 2017), https://thefederalregister.org/documents/2017-19029/self-collection-devices-for-pap-test-public-workshop-request-for-comments.