Benefits of FDA Third-Party Review Programmes
It is indisputable that third-party review can speed the time to market for a 510(k) and prevent RTA. On the other hand, does the money need to be spent?
Does the time to market matter? Are you sure enough of your 510(k) competence that you are equally sure FDA will accept your filing? Did you do, or have you planned a pre-sub with FDA? Does your submission even qualify for third party review?
These are all important questions to ask yourself, and each should be addressed at the earliest possible stages of medical device development.
This paper introduces the reader to the Accredited Persons Programme and provides insight into the various considerations in making a cost/benefit decision with regard to utilization of the programme.