A: To understand what regulatory requirements apply to your digital health product, first you need to understand whether your digital health or software product is a device that is the focus of the FDA’s oversight. 

To get started, we encourage you to explore the FDA’s Digital Health (DH) Policy Navigator. The DH Policy Navigator provides an interactive overview of digital health policies to help you understand how the policies may apply to your product. It can help you determine whether a software function meets the device definition and, if so, whether it is the focus of the FDA’s oversight. 

The DH Navigator helps to identify the most relevant laws, guidances, or policies to consider for understanding the regulatory status of each of your product’s software functions and to highlight certain considerations in specific guidances or policies. 

After answering the questions for each step, unless the tool directs you to the next step, a possible outcome is provided. At this point the use of the Navigator is complete for that particular software function. The possible outcomes are: 

• Likely not a device,
• Likely the FDA intends to exercise enforcement discretion, or 
• Likely the focus of the FDA’s regulatory oversight.

If your product is a device software function that is the focus of the FDA’s oversight, you will need to understand the applicable regulatory controls. Like all other devices, the applicable regulatory controls are determined by the classification of the device. Please read How to Study and Market Your Device to find out more about device classification and premarket submission requirements.

A: Marketing a Software as a Medical Device (SaMD) is similar to marketing any other medical device. The following steps can help you get started with the process of bringing a medical device to market in the United States and are available from our Device Advice page.  

• Step One: Classify Your Device and Understand Applicable Regulatory Controls 
• Step Two: Select and Prepare the Correct Premarket Submission 
• Step Three: Send your Premarket Submission to the FDA and Interact with FDA Staff During Review 
• Step Four: Comply with Applicable Regulatory Controls Including the Establishment Registration and Device Listing.

A:  The term Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum (IMDRF) as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device." For a software product to be regulated by the FDA as a medical device, the software must meet the device definition, regardless of whether it meets IMDRF’s definition of SaMD. 

The definition of device can be found in Section 201(h)(1) of the Food, Drug, and Cosmetic (FD&C) Act. To learn more please visit How to Determine if Your Product is a Medical Device. You may also be interested in learning about the FDA’s approach to “device software functions” or software functions that meet the definition of a medical device. A good place to start is our guidance, Policy for Device Software Functions and Mobile Medical Applications and the Digital Health Policy Navigator.

If your product incorporates AI/ML, you may also want to explore our associated page on AI/ML-Enabled Medical Devices.

For more information on SaMD, please visit the FDA’s Software as a Medical Device webpage. 

A: Yes, you may contact the Digital Health Center of Excellence (DHCoE) and request informal feedback on your digital health product. DHCoE does not provide formal feedback such as device determinations or classifications.

To Get Formal Feedback: 

If you are seeking specific, formal feedback, you have several options. For formal feedback about your medical device, see the Pre-Submission process listed below. For the FDA’s views about the classification and the regulatory requirements that may be applicable to your product, see 513(g) Requests for Information, also listed below.

Pre-Submission: You may be interested in submitting a Pre-submission to receive feedback on your product from the relevant review group. Please note that the Pre-Submission is part of a voluntary program, and there are no user fees at this time. For more information, please read Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. You may ask for representatives from the DHCoE to be included in your Pre-Submission meeting.

513(g) Request for Information: To receive feedback on the FDA’s views about the classification and the regulatory requirements that may be applicable to your particular device, including what pathway may be appropriate, you may wish to submit a 513(g) Request for Information. Please read the FDA guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act to learn more. Please note that medical device classification will be determined by the risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness of the device, which is the responsibility of the review division that has subject matter expertise in the device.

To Get Informal Feedback:

DHCoE Informational Meeting: Please review the online information and regulatory tools. If you are interested in sharing information about your product with us without the expectation of formal feedback, we may arrange an Informational Meeting with Digital Health staff from the CDRH DHCoE and relevant subject matter experts. The meeting may help facilitate compliance with the regulations governing development and post-approval marketing of products. 

This would be considered a “Q-Submission to the FDA.” Please note, while the FDA staff may ask clarifying questions during an Informational Meeting, they will generally be listening during the meeting and not prepared to provide any specific feedback. This is an appropriate meeting option to consider if you are developing a medical device to market in the United States but not yet ready for a discussion to address specific questions or to request specific feedback through a Pre-Submission meeting.

To schedule an Informational Meeting with the DHCoE, e-mail us at DigitalHealth@fda.hhs.gov stating your interest in an Informational Meeting and the product and topic you would like to discuss. Then, we can initiate the process of scheduling an Informational Meeting with you.

DHCoE Inbox: The DHCoE’s inbox, DigitalHealth@fda.hhs.gov, provides informal feedback to stakeholders seeking more information on the FDA’s digital health regulatory considerations. As a first step, we encourage you to explore the FDA’s many publicly available resources online to help answer your general questions.

A: Below are some resources that may be useful to understand the types of digital health devices that have been authorized. The Digital Health Center of Excellence (DHCoE) has published and maintains device lists for AI/ML-enabled and AR/VR devices, to help you identify medical devices that are incorporating these emerging technologies in health care.

Medical Device Databases: You can search within CDRH’s databases for similar devices in our medical device databases.

There are different CDRH databases for searching for medical devices based on their regulatory pathway (for example, 510(k) Premarket Notification, De Novo, Premarket Approval (PMA)). We encourage you to consider the regulatory pathway of the device you are searching for and select the database that corresponds to that pathway. Below we have highlighted some of the medical device databases that may be of interest to you and your search:  

• Product Classification Database
• 510(k) Premarket Notification Database
• De Novo Classification Database  
• Premarket Approval Database: 
  • Searching Key Terms for Existing Product Classifications: Finding an existing classification that matches your description of your product’s intended use or design is a good indicator that your product is likely a medical device and subject to the FDA’s oversight. To help you search for devices that have already been authorized, you may wish to search for terms relating to your device’s intended use in the Product Classification Database. For example, if you use the terms “cancer risk” in the Product Classification database, at this time, the search will result in the following three product codes associated with two different device classification regulations*: 
    • NYI: Classifier, Prognostic, Recurrence Risk Assessment, RNA Gene Expression, Breast Cancer (21 CFR 866.6040)
    • OWM: Prostate-Specific Antigen (PSA) For Prognostic, Recurrence Risk Assessment of Prostate Cancers (21 CFR 866.6040)
    • QAZ: Cancer Predisposition Risk Assessment System (21 CFR 866.6090)

*Please note, this example is meant to illustrate the utility of the Product Classification Database and is not a classification recommendation.

You may also be interested in our device lists for both AI/ML-Enabled Medical Devices and AR/VR Devices. You can browse these lists to see what AI/ML-Enabled and AR/VR Medical Devices have been cleared, granted, or approved; as well as the marketing pathways that were applicable to these devices. We plan to update this list on a periodic basis. Please note that only publicly available information is used in developing this list, so it is not intended to be comprehensive.

AI/ML-Enabled Medical Devices: One of the many resources on AI/ML-Enabled Medical Devices available on our website is our AI/ML-Enabled Medical Devices List. As technology continues to advance every aspect of health care, software incorporating artificial intelligence (AI), and specifically the subset of AI known as machine learning (ML), has become an important part of an increasing number of medical devices. Over the past decade, the FDA has reviewed and authorized a growing number of devices legally marketed (via 510(k) clearance, granted De Novo request, or approved PMA) with ML across many different fields of medicine—and expects this trend to continue.

AR/VR Devices: Augmented Reality and Virtual Reality (AR/VR) have the potential to transform health care, delivering altogether new types of treatments and diagnostics, and changing how and where care is delivered. Did you know we have a page dedicated to AR/VR? It includes a brief tutorial on what AR/VR is, how AR/VR impacts medical devices, news and updates, and more resources. This page is also home to our list of authorized medical devices that incorporate AR/VR, which the FDA updates periodically.

A: As technology continues to advance every aspect of health care, software incorporating artificial intelligence (AI), and specifically the subset of AI known as machine learning (ML), has become an important part of an increasing number of medical devices. One of the greatest potential benefits of ML resides in its ability to create new and important insights from the vast amount of data generated during the delivery of everyday health care. The FDA is committed to ensuring that AI/ML-enabled devices are safe and effective while facilitating innovations in their development. You can learn more about some of our recent work on artificial intelligence and machine learning (AI/ML)-enabled medical devices on the pages listed below. 

• Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions, Draft Guidance: The FDA issued this draft guidance to further develop a regulatory approach tailored to AI/ML-enabled devices, to increase patients’ access to safe and effective AI/ML-enabled devices, to protect and promote public health. This draft guidance describes a least burdensome approach to support the iterative improvement of machine learning-enabled device software functions (ML-DSFs) while continuing to assure their safety and effectiveness.
• Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan: The FDA issued the Action Plan as a direct response to stakeholder feedback to the April 2019 discussion paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device” and outlines five actions the FDA intends to take. Please note that these are not guidance documents and do not represent currently implemented policy. 
• Good Machine Learning Practice for Medical Device Development: Guiding Principles: The FDA, Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). These guiding principles will help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).
• AI/ML-Enabled Medical Devices: The FDA updates this list on a periodic basis. Please note this list is generated from publicly available information only, and it is not intended to be comprehensive. You may browse through these documents and see by what type of marketing pathway other AI/ML-enabled medical devices were brought to market and what types of devices in this space have been cleared, granted, or approved. 

A: Medical devices, including digital health devices, that are being studied to evaluate safety and effectiveness in a clinical investigation are subject to the investigational device regulations described in 21 CFR 812. An investigational device exemption (IDE) allows the investigational device to be used in a clinical study to collect safety and effectiveness data.

You can learn more about IDEs on our Investigational Device Exemption webpage. To receive feedback from the FDA regarding the regulatory requirements for a medical device clinical study, we recommend that you submit a Study Risk Determination through the Q-submission Program.

For additional information on this topic we recommend you consult the FDA guidance: Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors Significant Risk and Nonsignificant Risk Medical Device Studies (Issued January 2006). 

Please note, the FDA’s decisions are based on scientifically valid and ethically derived data. We encourage you to learn more about Good Clinical Practice (GCP). Conducting clinical studies in accordance with 21 CFR 812 is one way to help ensure clinical data are credible, accurate, and ethically procured. Therefore, if you intend to use the data from a clinical investigation to support a premarket submission, we encourage you to refer to the guidance Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions.

A: Check out the Mobile Health App Interactive Tool, jointly developed by the FDA and the Federal Trade Commission. The online tool is for anyone developing a mobile app that will access, collect, share, use, or maintain information related to an individual consumer’s health, such as information related to diagnosis, treatment, fitness, wellness, or addiction.

This resource was produced in cooperation with the U.S. Department of Health & Human Services: the Office of the National Coordinator for Health Information Technology, the Office for Civil Rights, and the FDA. 

A: You may browse through a list of released guidances with digital health content.

You may also find more information at CDRH Proposed Guidance Development. The lists on this page include guidance documents the FDA’s Center for Devices and Radiological Health (CDRH) intends to publish each fiscal year, as well as previously-issued final guidances for which CDRH is interested in receiving external feedback regarding whether these guidances should be revised or withdrawn.

A:  The Precertification Pilot Program ended in 2022 with the published final report The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings.

While the Pre-cert Pilot program has ended, the Digital Health Center of Excellence (DHCoE) will continue to consider and refine the concepts the pilot embodied, including through regulatory science work in partnership with organizations like the Medical Device Innovation Consortium (MDIC), with the ultimate goal of empowering stakeholders to advance health care by fostering responsible and high-quality digital health innovation.

The FDA continues to review and authorize software functions that meet the definition of device (under section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act) to the U.S. market, through established regulatory mechanisms.

A:  The Digital Health Center of Excellence is focused on helping with digital health policy and technology related questions. The FDA’s device registration and listing page contains a number of valuable resources including a tutorial, important reminders, and information on when and how to register and methods to contact their office.

Stay up to date on the FDA’s digital health policies by visiting the Digital Center of Excellence (DHCoE) homepage. Also, you may want to subscribe to receive digital health email updates.