The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has issued three new draft guidances as part of an effort to modernize its 510(k) Program for new products that can be found...more
On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the normal regulatory process was temporarily...more
1/22/2021
/ 510(k) RTA ,
Department of Health and Human Services (HHS) ,
Exemptions ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Notification Requirements ,
Pharmaceutical Industry ,
Regulatory Reform ,
Request For Information
On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will supersede the currently in effect Special...more