View draft revisions of FDA guidance?

Is it possible to view draft revisions of FDA guidance documents when they are a “work in progress,” or are they only become available once published as draft? 

This is a frequent question that I have heard. However, the FDA does not typically provide copies or drafts of “works in progress” for those items that will eventually become draft or final guidances.

I know of three primary reasons for this practice:

  1. First, since it is a “work in progress” the content of the soon-to-be drafts can change on a daily and/or weekly basis as the work product evolves. The agency avoids publishing incomplete or evolving information.
  2. Second, the agency believes that it is best practice to only make the information available to all parties at the same time as to avoid any party from having any competitive advantage. Incremental release of “works in progress” can lead to what later may become misinformation – which may result in companies expending resources on items that may not even appear in the published guidance.
  3. Third, after the FDA work group completes its work, and prior to publication, the document must then go for legal and senior management review. Legal and Senior Management do not generally allow for review of “work in progress” drafts. The amount of legal review and senior management review can include CDRH, FDA, HHS and in some cases the White House, depending on the topic and the sensitivity of the topic.

The timing and publication date of drafts is highly dependent on other higher priority items that may need to get legal or senior management review first. For example, here in 2020, it is likely that COVID-19 publications have the highest priority, and there are likely many other drafts that simply need to wait their turn until the high priority traffic clears.

TIP: Despite this, some elements of internal drafts are sometimes discussed in public presentations given by FDA staff, so it is worth looking for recent presentations related to the guidance of interest.

 

Other options if you have a specific question or issue are as follows:

Questions about Medical Device Regulation

Questions about Interpreting Digital Health Guidance

 

Find more FDA posts here: FDA Tag

About the author

John is a 25 year FDA veteran. John served as a regulatory and compliance expert for FDA regulated computers and software. Practice (focus) areas include FDA software related guidances, software device classification determination, pre-market software review, post market software inspectional 483’s, additional information software requests, Digital Health Pre-certification, AAMI Software related TIRs and related medical device software standards.

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