DisclosureDisclosure is an important part of both the USPTO patent application process and the FDA regulatory review process. The specific disclosuresDisclosure required by the USPTO and the FDA can sometimes be problematic for those involved in both the patent application process and the regulatory review process. Generally speaking, disclosuresDisclosure made to the USPTO must also be made to the FDA, and vice versa. Failing to make a disclosureDisclosure when disclosureDisclosure is required can lead to a finding of inequitable conduct during prosecution of the patent, which can result in the patent being invalidated, and/or can prompt the FDA to initiate an investigation as to whether significant questions regarding data integrity and reliability with respect to a regulated product have been raised for a medical device product that is under review. Being aware of disclosureDisclosure requirements and the consequences of failing to comply with them can help avoid serious pitfalls during the patent prosecution and regulatory processes.