What are FDA Guidance Documents? Why should we use them? Do they have any legal weight? These are questions that many organizations have when trying to understand FDA compliance and how the FDA works. Since FDA Guidance Documents contain a wealth of information that many of our Document Center customers find to be very helpful, I’m going to discuss these publications in general today. My goal? To give you a better idea of when and how to use them to improve the way you interact with the FDA.
Guidance Documents are published by the FDA on a regular basis. They are a methodology they use to communicate information about FDA processes and regulatory requirements. These publications do not have any legally binding status. They just are a way for the FDA to let you know what their current thinking is on a topic or how they deal with certain issues or about new processes that you’ll be asked to meet.
One area that FDA guidance documents cover is submissions: how to make your submissions, how your submissions will be reviewed, what they should contain, and so on. If you’re unfamiliar with what documentation you need to provide and how it will be processed, guidance documents can explain this to you in general terms. And occassionally you’ll even get an overview of a specific issue for submissions, as when the “Refuse to Accept Policy for 510(k)s – Guidance for Industry and Food and Drug Administration Staff” was recently released. This document covers a specific situation for submissions, what it means and how to deal with it.
Another area that’s addressed is compliance, inspection and enforcement. For anyone with FDA regulatory requirements, understanding how an inspection can take place and what the inspector(s) will be looking for is critical. Promoting compliance with regulatory requirements over time is an important aspect of the FDA’s mission. So you’ll find such publications as “Unique Device Identification System: Small Entity Compliance Guide – Guidance for Industry and Food and Drug Administration Staff” available to help you in this regards.
And the other main area that’s covered by guidance documents are about the regulated products or processes themselves. You’ll find information in these publications on design, production, labeling, promotion, manufacturing, and testing. They’re a critical communications tool for the FDA.
Some are issued for products that are “hot” as when there was some concern over sterility processes for endoscopes recently. The FDA issued an update for it’s publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling – Guidance for Industry and Food and Drug Administration Staff” to help resolve this issue. And alongside the FDA’s guidance release, standards organizations also looked to improve processes defined by standardization for this topic.
Others are issued when the FDA or industry perceive that additional information is required to get the desired level of safety and reliability necessary for the public’s well-being. These can be about very specific topics or more general, like the recent “Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings – Guidance for Industry and Food and Drug Administration Staff.”
So, as we mentioned before, FDA Guidance Documents are not a requirement, but they can offer medical device developers and manufacturers a wealth of information to improve the way that you interact with the Administration. If you’re in this industry, you should monitor these publications on a regular basis. One easy and effective way to do so is to review the blog.document-center.com on a regular basis. Just yesterday, I posted the new Medical Device Guidance Documents that were released during the 4th quarter of 2016! Check it out.
And don’t forget: Document Center Inc. not only provides you with the standards you’ll need but also gives you access to regulations and supporting documentation necessary to achieve compliance and safety in your product line. Order the material you need at our webstore, www.document-center.com. Or if you have additional questions, reach us by phone (650-591-7600) and by email (info@document-center.com). We’re here to support your quality and compliance requirements! Make us your Standards Experts!