Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device and digital health products. These executive orders may, for example, delay pending regulations, create uncertainty for FDA’s prior guidance related to artificial intelligence, and adversely impact FDA staffing and resources.
We describe below the key executive orders that could affect FDA’s medical device operations.
Present Trump’s Executive Order on Regulatory Freeze Pending Review requires federal agencies, including FDA, to cease proposing or issuing any rules in the Federal Register “until a department or agency head appointed or designated by the President . . . reviews and approves the rule.” While it is not uncommon for rulemaking to pause during a presidential administration transition, the executive order makes the pause explicit and could thus be for an extended period of time.
This freeze, and the requirement for agency head review, will delay any pending or planned rules by FDA. For instance, rulemaking required to implement new device classifications resulting from de novo authorizations could be impacted by the executive order.
Although President Trump has stated his intent to appoint Dr. Martin Makary as FDA commissioner, this position requires Senate confirmation and Dr. Makary’s confirmation hearing has yet to be scheduled. Dr. Sara Brenner has now been appointed as acting FDA commissioner, however, and presumably would have the authority to review and approve new rules until Dr. Makary is confirmed. Nonetheless, the requirement for all rules to be reviewed and approved by Dr. Brenner may result in delays.
This executive order also impacts rules that were previously published and finalized but “have not yet taken effect,” requiring federal agencies to consider postponing the effective date for such rules for 60 days “for the purpose of reviewing any questions of fact, law, and policy that the rules may raise.” Agencies are further directed to consider reopening comments during this 60-day period “where appropriate and consistent with applicable law.”
This directive could affect recently finalized FDA rules impacting medical devices that have not yet taken effect such as the final rule for laboratory-developed tests (on which we previously wrote) and the final rule to update the Quality System Regulation (21 CFR Part 820) to align with ISO 13485:2016 (discussed in our prior LawFlash).
The new Executive Order on Initial Rescissions of Harmful Executive Orders and Actions rescinded a number of executive orders issued by former President Biden, including Executive Order 14110 on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, which outlined principles for the oversight of AI across government agencies, including FDA. The new Executive Order on Removing Barriers to American Leadership in Artificial Intelligence, which is intended to “sustain and enhance America’s global AI dominance,” requires a review of “all policies, directives, regulations, orders, and other actions taken pursuant to the revoked Executive Order 14110” to assess whether any such actions are inconsistent with this goal.
The rescission of Executive Order 14110 will affect several FDA guidance documents and other resources related to AI. For example, FDA had cross-referenced Executive Order 14110 and used definitions from Executive Order 14110 in the final guidance for Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions and the cross-center discussion paper on artificial intelligence and medical products.
FDA also uses many of the definitions from Executive Order 14110 in the online FDA Digital Health and Artificial Intelligence Glossary – Educational Resource. Those definitions were cross-referenced in the more recent draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.
It is not yet known to what extent the rescission of Executive Order 14110 will impact FDA’s overarching policies and priorities for AI and related digital health technologies, but in any case FDA will still have to review and update the aforementioned guidance documents and resources to address the rescission of Executive Order 14110.
The new Executive Order on Return to In-Person Work directs the heads of all federal departments and agencies to “take all necessary steps to terminate remote work arrangements and require employees to return to in-person work at their respective duty stations on a full-time basis.” While this executive order was not unexpected, it is unclear whether FDA, which previously adopted a hybrid work model, has sufficient office space to fully execute this new directive or how long it may take to implement.
This new executive order may also create employee retention challenges for FDA: specifically, many federal workers who have grown accustomed to remote work may choose to leave the agency in pursuit of remote or hybrid work options elsewhere. Additionally, FDA was able to recruit new talent by not restricting hiring to only regions where FDA offices were located and, regardless of how FDA and these employees comply with the requirements of this executive order, FDA’s ability to recruit in this manner may be diminished going forward. The impacts of this executive order are amplified by a companion executive order putting in place a governmentwide hiring freeze of indeterminate duration.
To the extent FDA’s Center for Devices and Radiological Health (CDRH) experiences a significant loss in employees, key medical device regulatory functions are likely to be adversely impacted, including the timely review of medical device premarket submissions, provision of feedback through the Q-submission program, and the issuance and finalization of new or updated guidance and regulations, among others.
The new Executive Order on Ending the Weaponization of the Federal Government directs the United States Attorney General to, in consultation with department heads and agencies, “review the activities of all departments and agencies exercising civil or criminal enforcement authority of the United States, including, but not limited to, the Department of Justice . . . over the last 4 years” to evaluate whether any such activities may be related to the “weaponization” of enforcement authorities against “perceived political opponents.”
The US Department of Justice (DOJ) generally represents FDA in any civil and criminal enforcement matters brought under the Federal Food, Drug, and Cosmetic Act for violations of the statutory and regulatory requirements related to medical devices. While these types of matters appear unlikely to trigger concerns of “weaponization” under the new executive order, the review mandated by the order is written very broadly and, once implemented, could potentially be resource-intensive and result in some general disruption and delays for pending and future enforcement activities brought by DOJ and other federal agencies, including FDA.
The executive order withdrawing the United States from the World Health Organization (WHO) may have implications for FDA/CDRH initiatives in which WHO is a participant or collaborator, though it is unclear at this time what the full impact may be on these activities.
These initiatives include the Medical Device Single Audit Program (MDSAP), which is intended to foster a global approach to auditing and monitoring of the manufacturing of medical devices; the International Medical Device Regulators Forum (IMDRF), an initiative intended to harmonize regulatory requirements for devices that may vary across countries; and Medical Device Connectors, an effort by FDA to collaborate with stakeholders to promote development of connectors that reduce the risk of device misconnections.
While several of President Trump’s recent executive orders will likely have a substantial effect on FDA’s medical device activities, there remains significant uncertainty around exactly how and when the executive orders will be implemented. These issues are expected to further evolve in the coming weeks and months as the new administration takes shape.
Morgan Lewis guides and provides strategic counseling for life sciences, medtech, and digital health companies, assisting them in assessing, anticipating, and navigating regulatory and legal changes, with broad experience in the regulation of medical devices, artificial intelligence, and other digital health technologies at both the federal and state levels.
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