Medical Device Software Guidance Navigator
A resource to help innovators identify FDA guidances that may be relevant to their medical device software development and marketing submissions.
The Medical Device Software Guidance Navigator (Guidance Navigator) is a resource designed to assist innovators with identifying relevant FDA guidance documents for their medical device software development and marketing submissions. This resource largely aligns to relevant sections of the electronic Submission Template And Resource (eSTAR) and provides a streamlined approach for innovators to identify initial guidances that may be applicable to their devices across the development life cycle.
The listings included in the Guidance Navigator are not comprehensive of all guidance documents that may be applicable to a given device. There may be other guidances applicable to your submission depending on the specific features of the medical device.
Which regulatory pathway is applicable for my device?
If you are currently determining whether your device software functions are potentially the focus of the FDA's oversight or determining which regulatory pathway is potentially applicable, you can first visit the Digital Health Policy Navigator and Digital Health Frequently Asked Questions (FAQ). At the end of the Digital Health Policy Navigator, there are resources to learn more about the FDA’s device digital health guidance documents and to engage with the FDA to receive feedback.
To search for guidances specific to medical device product codes, you can visit the Product Code Classification Database.
Using the Guidance Navigator
The Guidance Navigator provides a list of commonly applicable guidances across device types. This resource can be used to support the preparation of a marketing submission (via eSTAR, for example) and for initial guidance identification throughout the software device development life cycle. Each section of the Guidance Navigator contains descriptions and links to FDA guidances and other resources that may be relevant to a corresponding domain area of your medical device software development. Reviewing the sections may help you:
- identify potentially relevant and impactful guidances for your medical device software development,
- highlight certain considerations in specific guidances or policies that may support your premarket submission preparation, and
- locate additional FDA resources for preparing a marketing submission.
Each section contains pertinent FDA guidance documents and related resources for your consideration. For a complete list of guidances from the FDA's Center for Devices and Radiological Health, see Guidance Documents (Medical Devices and Radiation-Emitting Products).
- How to Study and Market Your Device
This page covers four steps that may assist you in navigating the process of bringing a device to the market in the United States. - Device Advice
This page explains medical device laws, regulations, guidances, and policies across the entire product life cycle. - Device Approvals and Clearances
This page provides FDA's information about medical device authorizations including links to searchable databases on its website containing 510(k), De Novo, and PMA information.
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
This guidance provides an overview of the mechanisms available to submitters through which they can request feedback in writing or during a meeting with the Food and Drug Administration (FDA) regarding potential or planned medical device Investigational Device Exemption (IDE) applications, Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, Evaluation of Automatic Class III Designations (De Novo requests), Premarket Notification (510(k)) Submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW), Dual 510(k) and CLIA Waiver by Application Submissions (Duals), Accessory Classification Requests, and certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) submitted to the Center for Biologics Evaluation and Research (CBER)) (specifically, INDs and BLAs for devices that are regulated as biological products under section 351 of the Public Health Service (PHS) Act). - Breakthrough Devices Program
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. - Safer Technologies Program for Medical Devices
This guidance describes FDA’s voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program.
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
This guidance provides information about the appropriate use of national and international voluntary consensus standards (referred to as consensus standards) in the preparation and evaluation of premarket submissions for medical devices. - Accreditation Scheme for Conformity Assessment (ASCA)
This program provides encouragement to medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions, as conformity to relevant standards both reduces regulatory burden and fosters quality.
- Content of Premarket Submissions for Device Software Functions
This guidance provides information regarding the recommended documentation for premarket submissions to support FDA’s evaluation of the safety and effectiveness of device software functions. - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
This guidance provides information about current review practices for premarket notification (510(k)) submissions to identify, explain, and clarify each of the critical decision points in the decision-making process FDA uses to determine substantial equivalence. - Requesting FDA Feedback on Combination Products
This guidance discusses ways in which sponsors can obtain feedback from FDA on scientific and regulatory questions regarding combination product and describes best practices for FDA and sponsors when interacting on these topics.
- General/Specific Intended Use - Guidance for Industry
This guidance identifies the general principles that will be considered by the Food and Drug Administration (FDA) in determining when a specific indication for use is reasonably included within a general indication for use of a medical device for purposes of determining substantial equivalence.
- Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff
This guidance describes how device product codes are used in a variety of FDA program areas to regulate and track medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). - Medical Device Databases
Medical device software sponsors can leverage FDA databases for various purposes, including understanding regulatory pathways, tracking a device’s regulatory status, and monitoring recalls. - FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
This guidance details how to obtain written information onthe agency's views about the classification and the regulatory requirements that may be applicable to a particular device. - User Fees for 513(g) Requests for Information
This guidance describes the user fees associated with 513(g) requests.
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
This guidance provides information about current review practices for premarket notification (510(k)) submissions and helps identify, explain, and clarify each of the critical decision points in the decision-making process FDA uses to determine substantial equivalence. - Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics
This guidance provides information to help 510(k) submitters demonstrate substantial equivalence and to serve as an aid for evaluating the benefit-risk profile of a new device in comparison to the predicate device. - Deciding When to Submit a 510(k) for a Software Change to an Existing Device
This guidance assists in determining when a software (including firmware) change to a medical device may require a manufacturer to submit and obtain FDA clearance of a new premarket notification (510(k)). - Safety and Performance Based Pathway
This guidance describes an optional pathway – the Safety and Performance Based Pathway – for certain, well understood device types, where a submitter would demonstrate that a new device meets FDA-identified performance criteria to demonstrate that the device is as safe and effective as a legally marketed device.
- Content of Premarket Submissions for Device Software Functions
This guidance provides information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions. - Multiple Function Device Products: Policy and Considerations
This guidance explains and provides examples of the regulatory approach and policy for all multiple function (contains both a software non-device function and a device function) device products and clarifies when and how FDA intends to assess the impact of ""other functions"" that are not the subject of a premarket review on the safety and effectiveness of a device function that is subject to FDA review. - Off-The-Shelf Software Use in Medical Devices
This guidance provides information regarding the recommended documentation sponsors should include in a premarket submission for FDA’s evaluation of off-the-shelf (OTS) software used in a medical device. - General Principles of Software Validation
This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices.
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
This guidance provides recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. - Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
Draft guidance is not for implementation. - Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products
Draft guidance is not for implementation. - Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
The AI/ML-Enabled Medical Device List is a resource intended to identify AI/ML-enabled medical devices that are authorized for marketing in the United States. It helps innovators by providing insights into the current market landscape and regulatory expectations, fostering innovation and ensuring public safety.
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
This guidance provides recommendations regarding cybersecurity device design, labeling, and the documentation to be included in premarket submissions for devices with cybersecurity risk. - Cybersecurity in Medical Devices Frequently Asked Questions (FAQs)
This page provides answers to frequently asked questions (FAQs) related to cybersecurity in medical devices. - Postmarket Management of Cybersecurity in Medical Devices
This guidance provides recommendations for managing postmarket cybersecurity vulnerabilities for marketed and distributed medical devices, and throughout the product life cycle, including during the design, development, production, distribution, deployment and maintenance of the device.
- Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
This guidance identifies specific considerations related to the ability of electronic medical devices to safely and effectively exchange information and use exchanged information, highlights considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices. - Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology
This guidance provides recommendations on design considerations, non-clinical testing, animal studies, and labeling to support premarket submissions for medical devices with physiologic closed-loop control technology.
- Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions
This guidance describes relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided in a premarket submission. - Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
This guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products. - Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions
This guidance provides recommendations on clinical performance assessments to support premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices applied to radiology images and radiology device data, including when a CADe device is part of a combined system, such as the detection portion of combined computer-aided detection and diagnostic devices. - Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions
This guidance provides recommendations regarding premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices applied to radiology images and radiology device data, including those marketed as a complete package with a review workstation, or as an add-on software embedded within imaging equipment, as an image review platform, or other imaging accessory equipment.
- Application of Human Factors Engineering Principles for Combination Products: Questions and Answers
This guidance contains questions and answers for industry and FDA staff on the application of human factors engineering (HFE) principles to the development of combination products. - Applying Human Factors and Usability Engineering to Medical Devices
This guidance assists in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses and use environments by improving the design of devices to minimize potential use errors and resulting harm.
- eCopy Program for Medical Device Submissions
This guidance provides clarification to the processing and technical standards for eCopies based on FDA’s experience to date with the program. - The Least Burdensome Provisions: Concept and Principles
This guidance describes the guiding principles and recommended approach to facilitate consistent application of least burdensome principles, i.e., the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time. - Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
This guidance clarifies how we evaluate real-world data to determine whether they are sufficient for generating the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices. - Global Unique Device Identification Database (GUDID)
This guidance provides the FDA's recommendations on the information necessary for labelers submitting data to GUDID.
Contact Us
For digital health-related questions, send an email to: digitalhealth@fda.hhs.gov.
For help determining if a product is a medical device, contact the Division of Industry and Consumer Education (DICE) or email DeviceDetermination@fda.hhs.gov.