“Radical Transparency” and “Deregulation” from Trump and RFK Jr.’s FDA . . . Unless it’s Useful to the Device Industry

Last week, FDA published a Request for Information (RFI) (here) seeking input from the public on its efforts to “to identify and eliminate outdated or unnecessary regulations.”  The Announcement raises several questions and issues for the device industry.

10-for-1 Rule and its effect on de novos.  The RFI reinforces Trumps January 31, 2025 executive order indicating that for every new regulation introduced, at least ten existing regulations must be eliminated (the “10‑for-1 Rule”).  To date, the 10-for-1 Rule does not appear to have impacted the granting of de novo authorization, which by their very process create a new classification regulation. Indeed, since the start of Trump 2, seven de novos have been granted.  The same order was in place during the first Trump Administration, with no actual impact on the issuance of new regulations for de novo authorizations, or any other regulations. During the first Trump Administration, the 10-for-1 Rule seemed to be more in name only when it came to FDA, whereas this administration seems more intent on its deregulatory approach, so we expect it to have more of an impact on FDA governance this time around. We will certainly be keeping a close eye on whether de novos become affected by this policy.

Radical Transparency.  The RFI promises that “HHS will publish annual reports detailing estimated regulatory costs and the specific rules being offset, promoting greater transparency and accountability.”  While transparency is an admirable goal, to date, the administration’s actions have stifled transparency, which will increase regulatory cost and burden for industry.  For example, while FDA updated certain guidance documents to remove terms offensive to this administration, like “gender,” since the start of Trump 2, not a single new device-related guidance has been issued.  Industry relies on guidance documents to understand the Agency’s current policy and practice.  Last fall, CDRH issued its annual guidance agenda (here) with dozens of planned guidance documents on important topics like cybersecurity, artificial intelligence, and device shortages.  It’s unclear if or when CDRH will begin issuing guidance documents again.

Beyond formal guidance documents, industry relies on prompt communication of 510(k) clearance and de novo authorization documents for new devices reviewed by FDA.  Following the April 1 reduction in force (RIF), however, there has been a significant delay in publication of these materials. For example, 510(k) summaries have routinely been posted within one to two weeks of the clearance. In April, not a single 510(k) summary was posted, however.  It wasn’t until early May that all of the 510(k) summaries (or statements) for the nearly 250 510(k)s cleared in April were posted.  As of the date of this post, not a single 510(k) summary has been posted for a 510(k) cleared in May even though the month is over half over.  We’ll be watching carefully to see if the trend of it taking a month or more to post 510(k) summaries continues.

Of the seven de novos granted since the Executive Order, two were issued before the RIF of April 1, and five after. None of the five issued after the RIF have posted classification letters. As we have previously reported, CDRH has a long history of failing to timely post decision summaries. The classification letters, however, were generally reported fairly quickly, within at least a month or so of the decision posting. It is therefore surprising that nearly a month or more has passed for four of these five de novos without any information being posted.

The impact of having no de novo classification letters and a lag in posting 510(k) summaries is significant, and will become more significant over time.  The classification letters are important because they include the special controls with which all similar devices must demonstrate compliance in a future 510(k) submission. It is necessary that the special controls be made publicly available as soon as possible to enable future manufacturers to use the de novo as a predicate device. The 510(k) summaries are similarly crucial to the development of new technologies because they allow companies to make substantial equivalence determinations about recently cleared devices. As FDA stated in guidance in 2023, “newer devices should be compared to the benefits and risks of more modern technology.” (here)

The delay in the availability of these documents may also create more work for CDRH review staff.  It is common for manufacturers, particularly those submitting a 510(k) using a de novo‑authorized device as the predicate, to submit a pre-submission to align on testing strategy and expectations.  Without access to the special controls, manufacturers will have no idea how to approach a pre-submission, which may require CDRH to provide significantly more guidance and direction than if manufacturers had a clear starting point to know at least the types of verification and validation that will be expected.

Deregulation Efforts.  The RFI is not all bad news and irony, though.  If this administration is actually interested in reducing regulatory burdens and getting novel technologies into the hands of providers more quickly, there is plenty of opportunity for CDRH to do so.  Over the last decade or so CDRH has moved away from granting clearance/authorization for new tools, instead forcing sponsors to get new clearances and authorizations for specific indications (e.g., specific patient populations, disease states, and procedures).  One examples of this is with robotic surgical devices, about which we have previously blogged  (here).  Not only has FDA required that each new robotic surgical device be authorized for a specific surgical procedure, FDA has also required that each system go through the de novo process, even if it is intended for the same surgical procedure(s) as an already cleared/authorized system. The administration could do some real good by bringing back the ability to get a tool, like a robotic surgical system, cleared so that those novel tools can be put in the hands of providers.

The RFI is open through July 14, 2025.  Comments can be submitted online through the docket (here) or through an online form specifically created for this effort (here).