Where Have All the Good Guidance Gone?

While this author needs no excuse to listen to Van Halen, one surprising source of inspiration came while reviewing the body of guidance documents issued by CDRH in the last year. While CDRH issued between 38 and 48 new draft or final guidance documents in the last three years of the Biden administration, CDRH has only issued 15 guidance documents in the first year (to date) of the new Trump administration (see table here).

There are several possible reasons for this slowdown. First, immediately after the change in administration, the White House instituted a freeze on issuing any new regulations or guidance unless reviewed by an agency head appointed by the new President (which, for FDA, did not occur until April 1, 2025). Then, on January 31, 2025, the President issued an Executive Order implementing the so-called “ten-for-one rule” whereby for each rule, regulation, or guidance issued an agency must rescind ten rules, regulations, or guidance. We’ve seen FDA publish regulations that it classifies as “deregulatory” and, therefore, exempt from this rule (see e.g., Final Rule reclassifying Hepatitis B assay). FDA could do the same for guidance documents, but it’s possible that there is some guidance the agency is unable to issue until it rescinds additional rules or for which the agency does not find it worth the cost of recission. The high turnover at the agency and reductions in force that have eliminated subject matter experts and policy staff may also be contributing to the slowdown in guidance.

Although one might hope that CDRH starts to issue more guidance documents as things settle at the agency, CDRH’s published agenda of Proposed Guidances suggests this may not happen. In last year’s agenda for 2025, CDRH planned to issue up to 29 guidance documents and, as we’ve seen, has only issued 15 year-to-date (note: we’re being a bit sloppy with Fiscal Year vs. Administration to avoid complicating the numbers). However, because the recently published agenda for 2026 only plans for up to 21 guidance documents, we are unlikely to see a meaningful increase in actual guidance issued.

Now you might be thinking: “why should I care if FDA issues fewer guidance documents”? As much as our law firm and others in the industry may quibble with portions of FDA’s published guidance documents, having advance, public insight into FDA’s thinking is vastly preferable to the alternative. In the absence of generalized guidance on which to rely, companies will need to seek more individual pre-submission feedback (premarket), or risk adverse inspection findings or regulatory letters (postmarket).

This is especially important as CDRH has not seen a similar reduction in performing inspections of, or issuing warning letters to, device firms. As shown in the below graphs (here and here), the rates of device-related inspections and warning letters are roughly on pace with previous years (with some notable bumps related to the early pandemic years).

And as we highlighted in a previous blog post, FDA appears to be issuing more warning letters for lower risk consumer devices rather than focusing on higher risk devices. As a result, companies may not be able to rely as heavily on FDA’s historical record of working with companies to remedy low-risk regulatory violations before the agency issues regulatory letters; instead, companies may want to be more proactive and conservative when ensuring regulatory compliance during this administration.

We plan to keep a close eye on these trends to see whether they persist throughout the new administration or turn out to be statistical noise.