FDA Issues New Guidance Documents, Notable Changes to Pre-Submission Process

The FDA has issued a number of guidance documents, primarily focused on the pre-submission process that medical device manufacturers use to improve the likelihood of success of a particular filing. 

All of the guidance documents are commitments made as part of MDUFA IV.  A link to the announcement of these guidance documents is here.  iuvo BioScience has reviewed these documents, and look forward to supporting our clients’ needs as we apply these guidance documents to our project delivery.