If you are in the Life Sciences Industry you have heard of FDA Guidance Documents, and specifically, if you are in a business where you have had to have some interaction with the FDA, you have likely made use of these very handy tools. However, no matter what field you are in, you may not understand quite how extensive this FDA resource is. FDA Guidance Documents are tools created to make the process of interacting with the FDA more efficient. In total, there are over 2,500 FDA Guidance Documents, and while most of these documents are related to the design, production, labeling, promotion, manufacturing, and testing of regulated products, there are also documents related to the evaluation or approval of submissions, as well as inspection and enforcement activities.1,2
As someone in the industry, the best way to make use of these documents would be to check and see if one exists for your product before you even begin designing it. That way, you know for sure that you are on the right pathway for FDA approval from the start. However, even if you do not make use of any of these documents until you are ready to apply for FDA approval, they can still be very helpful in ensuring that you have all your proper documentation. It is also good to be aware of these documents because they can impact which kind of 510(k) submission you are required to complete – if you leverage a guidance document to demonstrate the safety/effectiveness of your product, you will have to complete an abbreviated 510(k) submission, rather than a traditional 510(k) submission.3 (See our blog, “The Types of 510(k) Submissions” by Madison Wheeler from August 2020 to learn more about the different 510(k) submissions!)
FDA Guidance Documents are created as a group effort by FDA staff, industry members, and the public, in the hopes of covering any questions or concerns that anyone may have about the specific guidance. Typically, the FDA staff will prepare a guidance document, and it will exist as a draft guidance document for a set amount of time, in which industry members, and the public can contribute to it by making comments asking for clarification or more information.2 It should also be noted that using an FDA guidance document does not guarantee approval by any means, however, if you follow the outlined guidelines, your chances for approval do increase significantly.
If your company is working on developing a product and needs assistance using a guidance document, finding a guidance document, or ensuring that you are compliant with a guidance document, our regulatory experts at EMMA International can help! Give us a call today at +1 248-987-4497 or email us at info@emmainternational.com to know more.
1FDA (December 2020) Guidance Documents (Medical Devices and Radiation-Emitting Products) retrieved on 12/21/2020 from https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products
2FDA (December 2020) Search for FDA Guidance Documents retrieved on 12/21/2020 from https://www.fda.gov/regulatory-information/search-fda-guidance-documents
3FDA (September 2019) 510(k) Submission Programs retrieved on 12/21/2020 from https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-programs#abbreviated
