Mass layoffs at the U.S. Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA), will impact the medical device regulatory process, says Ben Wolf, partner in Alston & Bird’s Health Care Group.
Wolf, an FDA attorney, sat down with MobiHealthNews to discuss how staffing cuts at the Agency could lead to longer review times for medical device approvals...
The Duofertility Reader
Late last year the US Food and Drug Administration (FDA) cleared Duofertility, a computerized basal body temperature thermometer developed by Cambridge Temperature Concepts, with a 510(K). Cambridge Temperature Concepts developed the device, which is intended for use in measuring and recording basal body temperature as an aid in ovulation prediction to aid in conception,...
