FDA released a draft guidance document that describes the processes available to medical device companies to request an additional review of decisions and actions by CDRH officials. Companies that disagree with a decision or action taken by CDRH and wish to have it reviewed or reconsidered have several processes for resolution from which to choose, including the following: requests for supervisory review of an action; petitions; and hearings. These processes are broadly described in FDA regulations. This draft guidance document provides general information about each process, as well as guidance on how to submit related requests to CDRH and FDA.

The draft guidance can be accessed on FDA's website.