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  1. Digital Health Center of Excellence

Resources: How to Engage With the FDA Regarding My Software Functions to Learn More and Receive Feedback

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If you identified the potential for your product to be a device and the focus of the FDA's regulatory oversight, we recommend that you contact the FDA prior to marketing your product. Early interaction with the FDA on planned non-clinical and clinical studies and careful consideration of the FDA's feedback may improve the quality of premarket submissions, shorten total review times, and facilitate the development process for new devices.

The FDA provides several options and resources to assist product developers in obtaining more information about these guidances and policies.

Device Advice: The Device Advice section on FDA.gov is a helpful resource for comprehensive regulatory information that includes many aspects of medical device laws, regulations, guidances, and policies encompassing the total product life cycle.

CDRH Learn: For an in-depth overview on engaging with the FDA, applicable language, and regulatory programs, visit CDRH Learn and begin with the section on How to Study and Market Your Device.

How to Contact the FDA

We are here to help! To make sure you receive the information you need in a timely manner, please review the categories below and send your question directly to the relevant FDA team.

Send Email:

  • If you have a question about medical device regulation in general, email the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov or call 1-800-638-2041.
  • If you have questions about interpreting digital health guidance, email the Digital Health Center of Excellence at DigitalHealth@fda.hhs.gov.

Submit a 513(g) Request for Information: The Digital Health Policy Navigator is not intended to provide definitive information regarding classification and all applicable regulatory requirements for a specific device. If you would like the FDA's views about the classification and regulatory requirements that may apply to your device, you may submit a Request for Information in accordance with section 513(g) of the FD&C Act. For additional information, see the FDA guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act.

Submit a Pre-Submission: A Pre-Submission provides the opportunity for a submitter to obtain the FDA's feedback prior to an FDA device submission. The request should include specific questions regarding review issues relevant to the FDA device submission (for example, questions regarding cybersecurity considerations for the device; non-clinical testing protocols; design and performance of clinical studies and acceptance criteria). A Pre-Submission is appropriate when the FDA's feedback on specific questions is necessary to guide device development or submission preparation. The program is entirely voluntary on the part of the submitter. For additional information, see the FDA guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.

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