FDA guidance is a crucial resource for medical device manufacturers; Understanding how to comply with regulatory requirements can help to streamline processes and avoid costly risks. The FDA regularly updates such guidance to reflect current practices and technology. But what you may not know is that draft guidance comes with an opportunity to submit comments or suggest changes for consideration.
Our business development manager and Human Factors specialist Natalie Shortt sits on the BSI and IEC Standards Committee for IEC 62366, covering the application of usability engineering for medical devices. In this article she provides an overview of how manufacturers can engage with the FDA draft guidance feedback process and the benefits this can bring.
What is the scope for commenting on FDA draft guidance?
When the FDA releases a draft guidance, it usually comes with an opportunity to submit comments in relation to the content. These can be comments of any nature – support for particular concepts, suggestions for small changes or dissent to particular concepts.
For example, the FDA has recently released a new draft guidance regarding use-related risk for drugs, biological products and combination products, which is open for comment until 9th September 2024.
Why do it
Providing comments to the FDA is one of the best ways to make sure that your experience in the industry is taken into account when they are developing a final version of a guidance.
In this instance the FDA’s guidance aims to provide guidance to industry and FDA staff on the ‘purpose and content of a use-related risk analysis (URRA) and how a URRA can be used to determine human Factors (HF) data needs during product development’. If you feel the guidance could better achieve that for your development needs then registering your comments will ensure this is considered and potentially implemented in the final document.
Who should do it
Anyone who considers the guidance relevant to their product development process can consider themselves appropriate to provide comments. If you have credentials or experience that is relevant to the area, then make sure to say so – it might distinguish your comments from others provided.
It helps if you have direct experience developing use-related risk documentation such as a Human Factors Engineer, but even if you haven’t developed use-related risk documentation yet it could be worthwhile. For example, perhaps you are risk manager at a startup and you’re aware you will need to do use-related risk work but you aren’t sure what that will look like yet and some aspects of the guidance are unclear.
When to do it
Strike whilst the iron is hot! Although you can comment at any time, the FDA advises commenting before their defined deadline to ensure they consider your comment before they begin working on the final guidance document.
What you should know before you do it
Comments made through their e-portal will be visible to the public, including any details you provide on the comment submission page. These comments will be posted unchanged, so be mindful not to include any confidential or sensitive information.
It is important to know that a constructive, information-rich comment that clearly communicates and supports its claims is more likely to have an impact on regulatory decision making (but also try to be concise where possible).
Be mindful that your comment provides all the information they need to consider it complete, this is one of several reasons the Agency may decide not to post your comment.
How to do it (and where)
The relevant guidance document page will have a button ‘submit comments online’. You will then be taken to a page that has a handy ‘commenters checklist’ button. This provides tips to review before you submit comments, but submitting a comment is quite straightforward.
You can write your comment directly into a text box on the commenting page and consider the following:
- If you are commenting on a particular word, phrase or sentence, provide the page number, column, and paragraph citation from the federal register document
- If you disagree with a proposed action, suggest an alternative and explain why an alternative might meet the same objective(s)
- If you do not want to submit your comment(s) then you can also submit them via post. All submissions made via post must include the following details:
- The Docket Number (in this case, FDA-2024-D-2484 for “Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products”)
- For confidential information, mark the content or document as ‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION’.
We advise that when providing comments to the FDA, it is worthwhile to read all the available accompanying information regarding expectations, rules and procedures for submitting comments.
To find out more about how we can support your Human Factors and medical product development needs, please do get in touch.
