On August 31, 2026, the Securities and Exchange Commission (SEC) and the U.S. Food and Drug Administration (FDA) signed a memorandum of understanding (MOU) governing the sharing of nonpublic information relating to FDA-regulated products and activities. The MOU is not limited to enforcement matters and expressly contemplates the SEC’s use of FDA information in carrying out its regulatory functions, including the review of public company filings. The SEC contacts identified in the MOU include personnel from the Division of Corporation Finance, which oversees disclosure review.
For life sciences and medical technology companies, the practical significance is that the SEC may have greater visibility into information already in the FDA’s possession when evaluating public disclosures regarding regulatory status, product approvals, clinical development programs, and clinical trial results. As a result, discrepancies between the FDA records and statements made to investors may become easier for the SEC to identify. That said, the MOU is not legally binding and does not expand either agency’s underlying statutory authority.
The information-sharing arrangement is also subject to important limitations. The FDA will not disclose trade secrets or confidential commercial information protected from disclosure under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other applicable laws. Similarly, the SEC may not share FDA-provided information outside the agency without the FDA’s written consent. The MOU further provides that information exchanged between the agencies does not become public merely because it has been shared and does not waive any applicable confidentiality protections or privileges. In practice, FDA disclosure regulations and the FD&C Act continue to provide the primary guardrails on information sharing.
In light of the MOU, companies should ensure close coordination between regulatory and securities counsel when preparing public disclosures. For example, a company’s description of “positive FDA feedback” following a meeting with the agency should be carefully vetted against the FDA’s actual comments, including any qualifications, unresolved questions, or requests for additional information. FDA meeting feedback is advisory and does not constitute a decision regarding a future submission. Likewise, a Breakthrough Device designation reflects the FDA’s commitment to increased interaction and review prioritization, not a determination that a device is safe or effective or is likely to be authorized or approved.