FDA Guidance Documents Released Recently

The article reviews FDA guidance documents released in the past 90 days and provides links to those guidance.

For anyone responsible for monitoring new and revised regulatory requirements, you should check the FDA website for new and revised guidance documents at least once every month. If you are not familiar with these FDA resources, here are the links for two of the FDA web pages:

• Recent Medical Device Final FDA Guidance Documents
• Recent Medical Device Draft FDA Guidance Documents

Medical Device Academy will be updating this post weekly. We will also be updating training webinars and procedures associated with these guidance documents. The intent of this review is to help quality system auditors, quality managers, and other personnel responsible for regulatory affairs. It is difficult to stay current with the FDA regulations, and we are trying to make this easier.

New Final FDA Guidance Documents (Q3 2025)

There have been three new final FDA guidance documents released in Q3 2025:

1. Animal Studies for Dental Bone Grafting Material Devices – Premarket Notification (510(k)) Submissions – Guidance for Industry and Food and Drug Administration Staff – August 22, 2025
2. Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions – Guidance for Industry and Food and Drug Administration Staff – August 18, 2025
3. Medical Device User Fee Small Business Qualification and Determination – Guidance for Industry, Food and Drug Administration Staff and Foreign Governments – July 30, 2025

New Draft FDA Guidance Documents (Q3 2025)

There have been no new draft FDA guidance documents released since January 2025 due to a shift in federal policy.

Animal Studies for Dental Bone Grafting Material Devices

This guidance is specific to dental bone grafting material devices. This guidance was originally issued as a draft on March 29, 2024. The devices included within the scope of the guidance are limited to the class II bone grafting material devices regulated under 21 CFR 872.3930 with the following product codes: LYC, NPM, and NUN.

Predetermined Changed Control Plan for AI-Enabled Device Software Functions

This guidance is specific to device software functions (i.e., SiMD or SaMD) that is enabled with artificial intelligence (AI). This guidance was originally issued December 4, 2024. The FDA is issuing this guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. The guidance is intended to support iterative improvement through modifications to AI-enabled devices while continuing to provide a reasonable assurance of device safety and effectiveness.

Medical Device User Fee – Small Business Qualification and Determination

This guidance is specific to small businesses (i.e., companies with annual revenue of less than $100 million). The small business qualification must be renewed each year. Most small businesses we work with fail to submit the form early enough to take advantage of this deduction, or the companies have difficulty gathering the tax records required for the application. You can download the applicable forms and guidance from our website using the links provided below (Updated July 2025):

• Link to FDA Form 3602N for US Companies, Subsidiaries, Parent Companies, and Foreign Companies (New July 2025 Universal Form)
• Link to FDA July 2025 Guidance (updated guidance)

Medical Device Academy has a web page dedicated to this process and we can help you complete the application and submit it as a consulting service if needed.

How to keep up on FDA Regulation Changes

If you are interested in keeping up on new and revised regulations from the FDA, I wrote a blog explaining four ways to identify new and updated FDA regulations. The blog identifies FDA web pages for the following four types of updates:

1. Guidance Documents
2. Recognized Consensus Standards
3. Device Classifications
4. Total Product Lifecycle (TPLC) Database

If you would like to receive email notifications where there are new or revised FDA guidance documents, please sign-up for our Lead Auditor Training course. Anyone that purchases the course will receive email notification of updates. They will also receive access to new and revised training to help them audit new and revised regulations as they are released.