It may seem as if a negative decision on your device application is final; however, that is far from the truth. CDRH has multiple processes for resolving disputes with any external stakeholders (sponsor, industry, or public) which are included in the applicable statues and regulations. These processes are also more simply described in the recently updated and issued guidance and Q&A documents. These documents will supersede the previous guidance on August 1, 2019. The guidance notes that the best way to resolve disputes is through discussion and agreement with the individual charged with managing the matter under dispute. Where agreement is unlikely, Center management and the CDRH Ombudsman may also be asked to participate in the discussion. There are 4 processes described in the document – supervisory review (also known as appeal), the Medical Devices Dispute Resolution Panel, petitions, hearings, and judicial review. A formal request for review may be filed at any time, and several of the available processes may be in progress on any particular dispute. It’s important for sponsors to be aware of the options as part of strategic planning on any device, but I recommend focusing on a collaborative approach with your review panel in all cases. What’s interesting to me are the options for citizens to challenge a decision (see the petitions section) – I wonder how often this process has been used, and for what devices.

Text Copyright © 2019 Katrina Rogers