premarket Archives - In Compliance Magazine

FDA Launches New Premarket Submissions Tracker

The U.S. Food and Drug Administration (FDA) has now made available an online platform for uploading and tracking the progress of premarket submissions for medical devices. According to a posting on the FDA’s... Read More...

FDA Seeks Feedback on Premarket Submission Progress Tracker

The U.S. Food and Drug Administration (FDA) is requesting input on a planned web-based tracking system that would allow medical device manufacturers to view the progress of their premarket submissions through t... Read More...

FDA Updates Database of Recognized Consensus Standards for Medical Devices

The U.S. Food and Drug Administration (FDA) has updated its list of recognized standards that can be used in support of premarket submissions for medical devices. Notification regarding the changes to the FD... Read More...

FDA Proposes Updates to List of Class II Exempt Devices

The U.S. Food and Drug Administration (FDA) has proposed updates to its list of certain medical devices exempt from its premarket notification requirements. According to a Notice published in the Federal Reg... Read More...

FDA Releases Guidances on Benefit-Risk Determinations for Medical Devices

The U.S. Food and Drug Administration (FDA) has published two final guidance documents related to benefit-risk determinations in medical device premarket approvals, de novo classifications and humanitarian devi... Read More...

FDA Releases Guidance on Diagnostic Ultrasound Systems

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has issued recommendations for medical device manufacturers seeking marketing clearance for diagnostic ultras... Read More...

FDA Issues Guidance on Premarket Submission Info on Performance Testing

The U.S. Food and Drug Administration (FDA) has issued a new guidance intended to help manufacturers of medical devices better understand the agency’s requirements regarding the submission of certain performanc... Read More...

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