Day: April 12, 2018

FDA plans to accept 510k applications for medical devices that show compliance with FDA defined standards rather than direct comparison to the predicate device by expanding its abbreviated 510k program under the least burdensome philosophy. FDA will release a list of 510k devices that could use this new program along with consensus standards and expected … Read more

Two new FDA guidance documents discuss the practical and regulatory aspects of testing new products in children and pregnant women confirming the well-established industry practices for these populations. Both documents emphasize the need to test new drugs in children and pregnant women only when absolutely necessary and to use alternate data sources to reduce clinical … Read more