How to Utilize FDA CDRH’s DICE

Introduction

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) plays a crucial role in the development and approval of medical devices. In particular, the Division of Industry and Consumer Education (DICE) within CDRH serves as an official gateway providing essential information and educational services to medical device developers and consumers. This article explains the overview of DICE and methods for its effective utilization.

What is DICE?

DICE is the Division of Industry and Consumer Education established within the FDA’s CDRH. Its official mission is to “educate stakeholders with understandable and accessible science-based regulatory information about medical devices and radiation-emitting electronic products.” It plays a particularly important role as the first point of contact for small business entities and new market entrants to understand regulatory processes.

Key Features

• Free service (phone and email support)
• Informal advice (not legally binding)
• Centralized management of diverse online resources

How to Utilize DICE

1. Inquiry Channels

Method	Details	Response Time
Phone	(800) 638-2041 or (301) 796-7100 (Press 2 for Industry Team)	Monday–Friday (excluding U.S. Federal holidays)
Email	DICE@fda.hhs.gov	Typically within 48 hours (excluding weekends and holidays)
Online	Device Advice and CDRH Learn Portal	Accessible 24/7

When using email, a clear and well-structured question increases the likelihood of receiving a prompt and accurate response. The clearer the question, the faster and more precise the answer will be.

2. Example of an Effective Question Structure

To formulate effective questions, consider using the following structure:

Subject: Inquiry Regarding 510(k) Application Requirements

Body:

• Product Classification: ECG Monitor (Product Code DPS)
• Development Stage: Prototype completed
• Specific Questions:
  • Test items required for substantial equivalence evaluation
  • Clinical data submission requirements

3. Major Online Resources

DICE provides various online resources including the following:

Device Advice: A comprehensive information resource regarding regulatory processes with step-by-step guides, laws, regulations, guidance, and policies related to medical devices. Device Advice is CDRH’s premier text-based resource that explains medical device laws, regulations, guidances, and policies across the entire product lifecycle, covering both premarket and postmarket topics.

CDRH Learn: A multi-media educational resource featuring learning modules that address medical device and radiation-emitting product laws, regulations, guidances, and policies across the entire product lifecycle. These modules provide industry with information that is comprehensive, interactive, and easily accessible. Modules are provided in various formats including:

• Educational modules in presentation format
• Regulatory requirements checklists
• Application document templates
• Videos, audio recordings, and slide presentations

The educational content covers a wide range of topics and is continually expanding as FDA hosts new meetings and uploads recordings. In most cases, transcripts and slides from presentations are available for download for future reference.

Webinars and Stakeholder Calls: CDRH regularly hosts webinars on regulations and guidance, featuring FDA presentations with live stakeholder question and answer discussions about timely medical device laws, regulations, guidances, or programs.

4. REdI Conference

The Regulatory Education for Industry (REdI) Conference is a free annual conference led by FDA that provides the latest information on FDA regulations concerning drugs, medical devices, and biologics. This conference represents a valuable opportunity to stay informed about the latest trends in regulatory requirements. The conference is designed to provide participants with a strong, basic foundation in FDA’s regulatory requirements and create awareness of current activities. The REdI Conference addresses major advances and innovation across various aspects of medical product development, covering topics such as artificial intelligence applications, clinical trial designs, and regulatory pathways.

Appropriate Questions vs. Inappropriate Questions

When contacting DICE, it is important to understand the scope of appropriate questions.

Appropriate Examples	Inappropriate Examples
“GMP requirements for Class II medical devices”	“Whether design changes to our specific device are permissible”
“Review period for De Novo applications”	“Approval of our company’s clinical trial protocol”

For more specific product development consultations or technical details, it is recommended to utilize other consultation programs such as Q-Submission (formal pre-submission consultation).

Key Points for Strategic Utilization

1. Utilization in Early Stages

• Gathering basic information before establishing regulatory strategy
• Assistance in identifying applicable laws and regulations

2. Utilizing Educational Programs

• Incorporating CDRH Learn modules into new employee training
• Setting up automatic retrieval of annual regulatory update information

3. Support for Small and Medium Enterprises

• Resource introduction for reducing regulatory compliance costs
• Coordination with regional business support organizations

Practical Advice

1. Record Management

A unique case number is issued for all inquiries, so it is important to retain this reference number. This enables smoother subsequent communication.

2. Follow-up

If there are unclear points in the response, additional questions can be submitted using the same case number. This enables receiving consistent information provision.

3. Multilingual Support

For those who are not confident in English, it is recommended to prepare questions in concise English in advance. Clear and concise questions lead to more accurate responses.

4. Understanding the Informal Nature

It should be noted that responses from DICE constitute informal communication and do not constitute an advisory opinion, do not necessarily represent the formal position of FDA, and do not bind or otherwise obligate or commit the agency to the views expressed. When more official views are needed, it is necessary to utilize appropriate consultation programs.

Conclusion

FDA CDRH’s DICE (Division of Industry and Consumer Education) is a valuable resource for medical device developers and consumers to access regulatory information. Through various services including question responses by phone and email, provision of various online resources, and regular webinars and conferences, DICE provides information and education.

DICE is positioned as the “gateway” to FDA regulations, and when more detailed technical consultations are needed, dialogue with Q-Submission (formal pre-submission consultation) or assigned reviewers becomes necessary. The Q-Submission program allows medical device sponsors to request written feedback or schedule meetings with FDA regarding various premarket submissions, including Investigational Device Exemption (IDE) applications, Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, De Novo requests, and 510(k) submissions. The FDA finalized updated guidance on the Q-Submission program in May 2025, providing greater clarity on the various types of Q-Submissions available, including Pre-Submissions (Pre-Subs), Submission Issue Requests (SIRs), Study Risk Determinations, and Informational Meetings. Selecting appropriate resources at each stage of medical device development is key to efficient regulatory compliance.

By effectively utilizing DICE, it becomes possible to deepen understanding of medical device regulatory requirements and proceed more smoothly with the development process. For small manufacturers, researchers, and innovators in particular, DICE is an important means for understanding the complexity of regulations. Additionally, DICE staff are experts in educational materials for medical devices, making email inquiries to DICE the best starting point for learning about specific FDA programs, guidance, or policies. If they cannot answer an inquiry directly, they will make their best effort to find someone who can.