The Food and Drug Administration has begun reinstating numerous employees at its medical device division who were terminated during Presidents Day weekend, according to statements from industry group Advamed and information from FDA staff members who requested anonymity.
Multiple employees at the Center for Devices and Radiological Health (CDRH) confirmed they received communications over the weekend inviting them to return to their positions. The FDA subsequently restored their technology and security access credentials, enabling them to resume work on Monday.
An industry insider familiar with the situation indicated that the majority, if not all, of the dismissed CDRH personnel have been offered reinstatement. The returning staff members include specialists from various departments, including those working on diabetes technologies, artificial intelligence devices, and equipment related to neurology, cardiovascular care, and anesthesiology and respiratory medicine.
Advamed CEO Scott Whitaker expressed approval of the reinstatements in a written statement, noting that “a substantial number of expert reviewers” would be returning to the FDA. He emphasized that this development would help maintain an efficient device review process and advance critical medical technologies that American patients rely upon.
The reversals follow Whitaker’s earlier criticism of the cuts, when he warned that device application reviews were already facing delays or suspensions. At that time, reports suggested between 230 and 240 CDRH employees had been affected by the terminations.
According to Reuters reporting, the FDA plans to rehire approximately 300 personnel across the agency, including staff members involved in reviewing Elon Musk’s Neuralink project. The initial workforce reduction, implemented by the Trump administration, had affected over 1,000 FDA employees.
Additional departments seeing staff reinstatements include surgical and infection control devices, digital health, and cardiovascular devices, as reported by Stat news, citing anonymous sources.
Regulatory consultant Steven Grossman of HPS Group observed that the initial terminations appeared to target probationary employees, particularly those in their initial years of government service or recently promoted through competitive recruitment. “While the reinstatements are positive, they don’t fully address the damage caused by implementing layoffs without proper performance
evaluations,” Grossman noted.
Despite the reinstatements, uncertainty remains regarding the timeline for affected device applications. Some employees had already surrendered their work equipment and security credentials during the brief period of termination.
The situation has raised concerns about the United States’ position as a leader in medical device innovation and potential impacts on patient care. The rapid reversal of the terminations suggests recognition of the critical role these specialists play in maintaining the FDA’s regulatory capabilities and ensuring public health safety.
The reinstatements represent a significant shift in position following what appeared to be one of the largest workforce reductions in recent FDA history. The episode has highlighted the importance of maintaining continuity in the agency’s regulatory oversight functions,
particularly in specialized areas requiring specific technical expertise.
Industry observers continue to monitor the situation for any lasting effects on the FDA’s ability to process device applications
efficiently and maintain its regulatory responsibilities. The incident has also sparked discussions about employment security for federal workers and the proper procedures for implementing significant personnel changes at critical regulatory agencies.