Can I get a Translation Please? 3 Tips to Ensure Productive Regulatory Communication, Part One

Editor’s note: This is a two-part series. In part one, Andrea Artman provides three insightful tips on how to prepare your submission to best communicate with regulatory authorities. In part two, she covers best practices for successful interactions with a reviewer.

Have you ever had a conversation where it seems that each party is talking past each other instead of finding a common thread? Many of my clients describe this feeling when discussing their technologies in the context of regulatory requirements and expectations. This plays out in frustration regarding the regulatory process, and can lead to stalled regulatory reviews and approvals.

As you know, regulatory documentation is full of highly technical information that describes the specifics of your unique product. Much of that information is generated during testing and will be very focused on ensuring you have the proper device history file information for your device and its manufacture. This information should continue to meet your company standards and include the language necessary for ensuring objective scientific evidence and language. However, in the content of the submission of specific information, there is ample room for providing a clear road map to how the very technical and specific data associated with your device meets the regulatory burden of your intended market and regulatory authority. As you “translate” your scientific and engineering outcomes into regulatory terminology, you have an opportunity to reduce or eliminate frustration and miscommunication that sometimes happens during the regulatory review process.

In this post, we will discuss strategies to ensure you’re speaking a language that your regulatory authority understands, and more importantly, a language that can get your product to market!

Mirror the Regulator’s Terminology

The best way to ensure your documentation is correctly translated into language that satisfies a regulatory review is to use the guidance documents, templates and regulations that are published by the regulators. Hopefully you are already referencing these publications to determine what to include in your submission and what testing would be expected for your device type. But these documents are also a treasure trove of useful regulatory terminology that you should be mirroring in your regulatory submission and often times in your test reports.

For example, assume the guidance document associated with your device type states, “We recommend that you provide the following information about the chemical composition of the device,” with a list of attributes. Effective submission text uses that same terminology, and could state, “per section X of the guidance document titled Y, the following chemical composition information is provided for the device under review.” Ensure that each characteristic description is followed by a specific page number where supporting documentation can be found. This will point the reviewer directly to the data you’ve determined meets this specific regulatory requirement.

If you’ve determined that a specific section of a document or regulation is not applicable to your device, do not stay silent on the topic. State, “section Z of guidance document Y is not applicable.” Be sure to provide a rationale for this assessment. This offers the reviewer assurance that you did not exclude this information by mistake. The more clearly you document your thought process and the data used to meet their needs, the more likely you will get your target outcome.

Following the basic structure and specific requests of available guidance documents, templates and regulations will help ensure the submission meets the regulators needs and will provide you with a better opportunity to get your product to market!

Use Bullet Points, Tables, Graphs and Colors

Don’t be afraid to use summarizing techniques such as bullet points, tables and graphs. It is difficult to read paragraph after paragraph and pull out the necessary information; providing information in a simple format makes it easier to digest for the reviewer. For example, if you are providing a test summary where all of your data meets acceptance criteria, put that information in a table and mark the “PASS” box in green. See the example below, which was adapted from the FDA Guidance titled “Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway,” issued on December 11, 2020.

This draws the reviewer’s eye to the acceptable and passing data. The technique can also be used if you do not meet your acceptance criteria, but don’t forget to include the rationale for the failing data and why this outcome is still acceptable.

Conduct an Independent Review

It is recommended that you have someone capable of providing an “outsider” viewpoint conduct a review of your communications with the regulatory authority. For efficiency, you can train your regulatory experts to conduct this review for each other, or you could utilize a new team member, someone in a different department or a consultant.

As an example, during product development, the names of products tend to change. The differences in naming that may show up in test summaries should be clarified so the reviewer understands that the product under review was in fact tested. Similarly, companies tend to name their manufacturing processes. These internal process names may not be intuitive to the reviewing authority. As such, either use universal terminology or provide an additional explanation of the process, which will ensure it is well understood upon review. These are simple updates that will make a major impact from a readability perspective!

These reviews are important to ensure that the submission text can be understood from someone that doesn’t know your company’s processes from the inside out – your regulatory reviewer will not have this insight either.

Final Thoughts

The above three tips are simple ways you can enhance your regulatory submission prior to sending it off to your regulatory authority. The tips will ultimately save you review time, frustration, and may reduce the need for a professional translation service. In the next post, I will provide some tips on how to have more productive communications with your regulatory authority.