Regulatory News In Brief
This article was originally published in The Gray Sheet
President Obama signs FDA user fee bill. FDA issues rules requiring PMAs for two pre-amendment devices. More regulatory news.
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FDA releases an update of its draft de novo classification guidance Aug. 14 to comport with FDA Safety and Innovation Act, and permit manufacturers to submit de novo applications for review without a preceding 510(k) submission.
FDA proposes class II for nonthermal shortwave therapy devices and updates regulations to reflect class II designation for neuropsychiatric assessment device. Meetings on manufacturing quality, clinical trials and medical countermeasures announced. More regulatory news.
Physician Payment Sunshine Act finally goes to OMB. FDA signs regulatory agreements with Brazil, Australia and Canada. More regulatory news.