# The latest (June 2023) changes to the FDA’s new premarket submission guidance Lee Chickering October 16, 2023 ## Table of Contents 1. [Part 1: Software Categorization has changed](#part-1-software-categorization-has-changed) 2. [Summary Table of Documentation Level Changes](#summary-table-of-documentation-level-changes) 3. [Part 2: Review of changes for required premarket submission documentation for device software](#part-2-review-of-changes-for-required-premarket-submission-documentation-for-device-software) 4. [Part 3: The Impact of Changes to the FDA 510(k) Pre-market Submission](#part-3-the-impact-of-changes-to-the-fda-510k-pre-market-submission) On June 14, 2023, a long-awaited new FDA guidance [_Content of Premarket Submissions for Device Software Functions_](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions) replaced the 2005 version which defined the content of software submissions. This guidance outlines key changes software developers, regulatory affairs, and quality professionals need to know about the differences between the original 2005 guidance and the 2023 version. The recent update brings significant changes to the submission process, particularly in the levels of documentation required based on the risk level of the device. We will guide you through the key points to clarify the FDA’s expectations while offering practical steps for you and your team to meet them without feeling overwhelmed. ## Part 1: Software Categorization has changed In the 2005 version, device software fell into one of three categories: **Minor, Moderate, and Major** levels of risk. These levels of risk determined the type and amount of design control documentation to submit to the FDA. In 2023, the FDA has “reduced” the software risk level categories to an **Enhanced** or **Basic** construct, changing the degree of design control documentation previously required. No device software is considered “Minor” anymore. Manufacturers whose device was previously categorized as “Minor” or “Moderate” will need to take a close look at the new requirements for their software documentation. In a recent webinar, the FDA made it clear that risk analysis is the determining factor for the assigned documentation levels. Companies, per the new mandated eSTAR program, must now complete a thorough Risk Analysis to determine if they qualify as Basic or Enhanced and submit their evaluation. This is called out in the 2023 premarket submission guidance document, _Table 1 . Outline of Recommended Documentation_—“A statement indicating the Documentation Level and a description of the rationale for that level [is required]." **Enhanced**: “Device software function(s) where a failure or flaw of any device software function(s) could present a hazardous situation with a probable risk of death or serious injury, either to a patient, user of the device, or others in the environment of use.” Device software previously labeled as Major falls under this category along with some Moderate categorizations. **Basic**: “Any premarket submission that includes device software function(s) where Enhanced Documentation does not apply”. Device software previously labeled as Minor along with some Moderate falls under this category Generally, devices that fall in the Basic category require less submission documentation than the Enhanced category. ## Summary Table of Documentation Level Changes ## **Part 2: Review of changes for required premarket submission documentation for device software** Here is a step-by-step breakdown of what stayed the same and changes that are now in effect as of August 14, 2023. You can also view our handy tool [here](https://airtable.com/appdPAU35K5ViKLTw/shrPCPYqc5BKiwoWw) to easily view changes based on either the 2005 or 2023 software categorization levels 1. Recommended Submission Documentation 2. Software Requirements Specification (SRS) 3. System and Software Architecture Design 4. Software Design Specification (SDS) The focus of the documentation levels is now centered around risk analysis. Improper and incomplete risk analysis may affect documentation levels. This is arguably the most important activity that is required per the guidance. Moderate software could be considered either basic or enhanced depending on the results of the risk assessment. This could increase or decrease the amount of document submissions required to support your product. ## Part 3: The Impact of Changes to the FDA 510(k) Pre-market Submission Over the years there has been a lot of confusion in determining the software LOC. In response, the FDA is clarifying the risk based activities that should be completed and artifacts expected from a Quality Management System. Based on the level of detail, the updated guidance is more explicit, leaving less room for ambiguity. Accordingly, the FDA expects all companies to comply promptly with the new requirements. For some manufacturers, this update will have minimal impact on their daily processes. However, many manufacturers will find that these requirements, which were once more general or unnecessary, will place a massive strain on their company’s bandwidth to produce the required documentation. The implementation of better tools and a coordinated quality management system (QMS) is more important than ever as manufacturers generate new documents for the first time while updating their previous ones. Keeping on top of compliance with the latest FDA guidance will help ensure a successful premarket submission and a smoother path to market approval.