Medical Devices; Draft Guidance for Industry on the Electro- Optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors: Submission Guidance for an IDE/PMA; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Draft Guidance for Industry on the Electro-Optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors: Submission Guidance for an IDE/PMA.'' This draft guidance is intended to identify the elements for an investigational device exemption/premarket approval application (IDE/ PMA) for any electro-optical sensor in vivo device for the detection of cervical cancer or its precursors. This draft guidance covers electro- optical devices applied to a woman's cervix in an in vivo setting that give a relatively instantaneous reading of test results for the purposes of detection of cervical cancer and its precursors. Many of these systems use complex signal discrimination algorithms and/or neural networks to differentiate abnormal from normal tissue. These new technologies, depending upon design and study results, may ultimately complement, as an adjunct, or replace the PAP smear, or it may serve to improve the results of colposcopy or biopsy. This draft guidance is neither final nor is it in effect at this time.