Electro-optical sensors guidance document
This article was originally published in The Gray Sheet
Comments on FDA's "Draft Guidance for Industry on the Electro-Optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors" are due Nov. 23, the agency says in an Aug. 25 Federal Register notice. FDA released the guidance in May (1"The Gray Sheet" May 31, p. 7)
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Test data that both demonstrates the biocompatibility of materials used at the device/cervix interface and characterizes the foreseeable hazards posed by optical radiation or thermal effects must be provided by companies seeking to market devices for the optical detection of cervical cancer and its precursors, FDA says in a draft guidance released May 24 on the agency's website.
Device Week, 4 December 2020 – MedWatch Question About Third-Party Servicers Slides Under Industry's Radar
On this week’s podcast: A change made by the US FDA to its MedWatch program that asks adverse event reporters whether a third party serviced a malfunctioning medical device went unnoticed by many in industry for nearly a year. We explain why, and tell how the servicer question will be helpful for manufacturers and the agency.
The series D financing will support the expansion of Everlywell’s consumer lab testing and digital health businesses.