USA – FDA finalizes which clinical decision software functions it regulates
The US Food and Drug Administration (FDA) announced that it has finalized guidance on which clinical decision software (CDS) functions it regulates as a...
USA – Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
As part of FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public
Health (herein referred to as the “Safety Action Plan”),1 FDA committed to...
USA – Pre-submission requests for IVDs to be accepted by FDA
The FDA in January restarted accepting pre-submissions for in vitro diagnostics that would require premarket authorization or de novo clearance. Now, the agency plans...
USA – Diversity plan draft guidance on track before year end, FDA official says
The US Food and Drug Administration (FDA) is on track to publish a draft guidance on diversity plans before year’s end, which will take...
USA – FDA will begin accepting breakthrough devices for TAP pilot in 2023
The US Food and Drug Administration (FDA) will start accepting products into its total product lifecycle advisory program (TAP) pilot starting in January. The...
USA – FDA extends regulatory flexibilities for PMA, HDE modifications
The US Food and Drug Administration (FDA) has published a final guidance that extends its pandemic-era policy of allowing manufacturers to make certain modifications...
USA – FDA asks manufacturers to develop risk management plans to avert shortages
The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drugs and medical devices are vulnerable to...
USA – Convergence: Tips for when to include PCCPs in product submissions
The US Food and Drug Administration (FDA) sees predetermined change control plans (PCCPs) as a way to improve medical device innovation in the country,...
USA – FDA device center guidance priority lists targets COVID, digital health
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has published its FY2023 guidance priority lists. Much of the...
USA – FDA classifies slew of class II devices following de novo procedures
Since the last week of 2022, the US Food and Drug Administration (FDA) announced it was classifying nine products as class II devices with...
