Differences Between PMDA General Consultation and FDA Pre-Submission

Introduction

The development and approval process for medical devices is subject to complex and stringent regulations internationally. Japan and the United States each maintain their own unique regulatory systems, and early consultation with respective regulatory authorities is critically important for bringing medical devices to market in both countries. This article explores the differences between Japan’s “General Consultation” conducted by the Pharmaceuticals and Medical Devices Agency (PMDA) and the United States’ “Pre-Submission” (abbreviated as Pre-Sub) conducted by the Food and Drug Administration (FDA).

Basic Overview of the Systems

PMDA General Consultation in Japan

PMDA’s General Consultation is a system that allows consultation on general matters related to review and consultation, including how to prepare application materials and organize consultation topics, prior to submitting an application for medical device approval. It is the most fundamental consultation category among face-to-face consultation services and is positioned as a preliminary stage before more detailed consultations such as Pre-Development Consultation, Protocol Consultation, and Pre-Application Consultation.

The primary purposes of General Consultation are as follows:

• Providing answers to general questions regarding approval applications and approval reviews
• Providing advice on organizing consultation topics and selecting appropriate consultation categories
• Providing advice on document preparation

FDA Pre-Submission in the United States

Meanwhile, the FDA’s Pre-Submission is positioned as part of the “Q-Submission (Q-Sub)” program. This is a formal mechanism for FDA and applicants to discuss specific issues before premarket submissions for medical devices (510(k), PMA, De Novo, etc.).

Pre-Submission is available free of charge, and applicants can receive FDA advice on clinical trial protocols, non-clinical testing plans, application strategies, and more. In May 2025, FDA finalized updated guidance on the Q-Submission Program, clarifying the types of consultations available and improving examples of when to use each type. The primary purposes of Pre-Sub are as follows:

• Feedback from FDA on key issues before submission
• Streamlining the submission process
• Advice on verification testing protocols
• Guidance on submission strategy

Detailed Analysis of Differences

1. System Structure and Costs

Japan (General Consultation)

• Consultation time is relatively short, set at 30 minutes or less
• It is a free service with no cost burden on the applicant
• By appointment, typically requiring approximately 2-3 weeks from application to implementation
• No summary record of the consultation is created, and PMDA does not issue a formal response document
• Implementation can be conducted face-to-face or via web conferencing (web conferencing became more common following the COVID-19 pandemic)

United States (Pre-Sub)

• Completely free to use with essentially no limit on the number of times it can be used
• Meeting time is relatively long, typically about 1 hour
• Being free of charge facilitates use from early development stages and allows for multiple consultations
• Meetings are typically scheduled approximately 70 days after submission
• Official meeting minutes are created within 30 days after the meeting
• As of 2025, FDA is promoting the use of electronic Submission Template And Resource (eSTAR) format for Pre-Subs. While currently voluntary, FDA plans to mandate eSTAR use for Pre-Subs approximately one year after finalizing the guidance on Electronic Submission Template for Medical Device Q-Submissions
• Various meeting formats are available, including face-to-face, teleconference, and video conference

2. Scope and Depth of Consultation Content

Japan (General Consultation)

• Primarily focused on procedural questions and advice on selecting consultation categories
• Detailed technical discussions and advice on specific review judgments are outside the scope
• Suitable for initial-stage questions such as “What consultation category should I use?” and “What materials should I prepare?”
• More detailed technical discussions are intended to take place in subsequent face-to-face consultations (such as Pre-Development Consultation) following General Consultation
• Strategic planning for approval applications is not possible
• Responses are generally informational or explanatory in nature regarding procedures

United States (Pre-Sub)

• Covers a wide range of content from detailed technical and scientific discussions to procedural questions
• Detailed advice can be obtained on specific content such as non-clinical testing plans, clinical trial design, and submission strategy
• Consultation is also possible regarding product classification and determination of submission pathways
• Multiple discussion points can be addressed in a single meeting
• FDA’s May 2025 guidance recommends limiting each Pre-Sub to no more than four primary topics to ensure focused feedback from reviewers
• Responses tend to be more direct and candid in expression, with clear identification of problematic points

3. Binding Force and Positioning of Responses

Japan (General Consultation)

• Binding force is limited as it does not remain as an official record
• Primarily verbal advice without creation of formal documents
• Positioned mainly as preparation for proceeding to the next stage of face-to-face consultation
• Responses in General Consultation are tentative views at best, and different judgments may be made in subsequent face-to-face consultations or reviews
• Applicants must take their own notes if they wish to maintain records

United States (Pre-Sub)

• Meeting records are officially created and serve as reference materials at the time of submission
• FDA clearly reserves the right to change views expressed in Pre-Sub based on changes in conditions or new information
• While legally binding force is limited, it serves as an important indicator of the direction of review in practice
• FDA may flexibly change its views in response to changes in scientific data or circumstances
• If adopting a policy different from advice given in Pre-Sub, the scientific rationale must be demonstrated
• FDA’s 2025 guidance emphasizes that early use of the Q-Sub process, particularly Pre-Subs, can significantly improve the quality of submissions and reduce review times

4. Nature of Communication and Response

Japan (General Consultation)

• Basically conducted face-to-face (web conferencing also available since the COVID-19 pandemic)
• Questions must be submitted in writing in advance
• Due to short consultation time, depth of discussion is limited
• Responses are centered on general information provision and procedural explanations
• Specific judgments and detailed technical advice are delegated to subsequent face-to-face consultations
• The main purpose is to guide toward the next step (more detailed consultation categories)
• There is no post-consultation follow-up from PMDA; consultants must resolve questions during the consultation itself

United States (Pre-Sub)

• Various formats can be selected, including face-to-face meetings, teleconferences, and video conferences
• Relatively flexible question-and-answer sessions are permitted
• Meeting time is set longer, allowing for detailed discussion
• Responses tend to be more direct and candid in expression, with clear identification of problems
• Discussions during meetings are more dialogical, with many opportunities for on-the-spot questions and answers and additional explanations
• There is a tendency to respond relatively flexibly to follow-up questions after meetings
• FDA recommends preparing comprehensive questions and supporting data before the meeting to maximize the value of the consultation

5. Authority Team Composition and Response

Japan (General Consultation)

• Typically handled by a small number of personnel, usually 1-2 persons from the review department
• Since procedural content is central rather than specialized content, specialists do not necessarily attend
• Team composition is relatively simple
• Due to short consultation time, detailed on-the-spot discussion is limited
• The number of attendees is limited to 5 or fewer for face-to-face consultations (no limit for web conferences, but applicants are requested to keep attendance to necessary personnel)

United States (Pre-Sub)

• Characterized by matrix-type composition where related specialists are gathered from multiple departments according to product characteristics
• In addition to the lead reviewer, diverse specialists such as engineers, clinical specialists, and statistical specialists participate
• There is flexibility to summon specialists in specific fields as needed
• FDA often holds internal pre-meetings to unify views on Pre-Sub
• There may be turnover of participants, which can sometimes pose challenges in ensuring consistency
• FDA staff may include representatives from relevant review divisions, the Office of Product Evaluation and Quality, and specialized consultants depending on the complexity of the device

Points for Strategic Utilization

Differences in the Positioning of Both Systems

Positioning of Japan’s General Consultation

• Acts as an entrance or information desk within the overall approval application process
• Serves as a bridge to more detailed face-to-face consultations (Pre-Development Consultation, Protocol Consultation, Pre-Application Consultation, etc.)
• Provides initial guidance on how to proceed with consultation and necessary materials
• Selection of consultation categories according to stage is necessary
• As of 2025, PMDA continues to enhance its digital transformation initiatives and is streamlining consultation processes

Positioning of the United States’ Pre-Sub

• Positioned as part of the Q-Sub Program (not a mandatory process before 510(k)/PMA submission)
• Functions as a substantial part of the submission process
• An important consultation opportunity that directly influences submission content
• An important step in shaping overall submission strategy
• As of 2025, FDA is actively promoting electronic submissions through the eSTAR program, with De Novo submissions already mandated to use eSTAR format as of October 1, 2025

Strategic Approach for the Japanese Market

To maximize the use of General Consultation, the following points should be noted:

Clarify Objectives: Recognize that General Consultation is merely initial guidance and clearly identify the information you want to obtain within the limited time available.

Prepare for the Next Step: Based on information obtained in General Consultation, proceed with preparation for more detailed face-to-face consultations (Pre-Development Consultation, Protocol Consultation, etc.).

Narrow Down Questions: Focus on procedural questions and questions regarding selection of consultation categories, deferring technically complex content to subsequent face-to-face consultations.

Utilize as Information Gathering: Use it as a venue for gathering basic information about PMDA’s thinking and review approach.

Consider Preparatory Interview: If time is needed to organize discussion points or prepare materials, consider utilizing a Preparatory Interview before proceeding to face-to-face consultation. The Preparatory Interview allows for organizing consultation content before face-to-face consultation and costs are later deducted from face-to-face consultation fees.

Strategic Approach for the U.S. Market

Points for effectively utilizing Pre-Sub are as follows:

Comprehensive Preparation: To make the most of limited opportunities, prepare a comprehensive list of questions including technical and scientific details. However, as per FDA’s 2025 guidance, limit the scope to no more than four primary topics per Pre-Sub to ensure focused feedback.

Long-term Perspective: With the awareness that discussions in Pre-Sub will affect the overall submission, prepare strategic questions.

Utilize Flexibility: Taking advantage of the free-of-charge nature, consider multiple Pre-Sub submissions as needed.

Systematic Management of Feedback: Establish a system to document advice from FDA and share and utilize it throughout the development team.

Leverage eSTAR Format: While currently voluntary, begin familiarizing your team with the eSTAR format for Pre-Subs in anticipation of the eventual mandate. eSTAR provides guided submission preparation, correlates with FDA’s internal review templates, and can help avoid Refuse to Accept (RTA) issues.

Follow-up Communication: Consider submitting follow-up questions or requesting clarification meetings if the initial Pre-Sub does not fully address all concerns.

Comparison of Key Characteristics of Both Systems

Comparison Item	PMDA General Consultation	FDA Pre-Sub
Cost	Free	Free
Consultation Time	Within 30 minutes	Approximately 1 hour
Schedule Adjustment Period	Approximately 2-3 weeks after application	Within 70 days after submission
Response Format	Oral (informal)	Official meeting minutes
Consultation Content	Procedural and system explanations	Discussion of technical details
Team Composition	1-2 review personnel	Matrix organization of multi-field specialists
Binding Force	Limited (no official record)	Moderate (official record created, but subject to change)
Electronic Submission	Not applicable	eSTAR format promoted (mandatory planned for future)
Follow-up	None (applicant must take notes)	Written minutes within 30 days, follow-up questions accepted
Frequency	No specific limit (but time-limited)	No specific limit, multiple meetings encouraged

Recent Regulatory Developments (2025 Updates)

Japan

• PMDA continues to advance digital transformation initiatives across its operations, including enhanced use of AI technologies for improving operational efficiency
• In June 2025, Japan enacted a new AI law (Act on Promotion of Appropriate Implementation and Utilization of AI) aimed at promoting innovation while managing risks, establishing a national AI Strategy Headquarters
• Nearly 100 AI-powered Software as a Medical Device (SaMD) products have received PMDA approval and insurance coverage as of 2025
• Enhanced UDI (Unique Device Identification) requirements and bilingual labeling standards (Japanese/English) are being implemented for greater transparency
• PMDA participated in and hosted the 28th International Medical Device Regulators Forum (IMDRF) Management Committee Meeting in Sapporo in September 2025

United States

• FDA finalized updated guidance on the Q-Submission Program in May 2025, superseding the June 2023 version
• FDA issued draft guidance on “Electronic Submission Template for Medical Device Q-Submissions” in May 2025, outlining the framework for mandatory eSTAR use for Pre-Subs after a one-year transition period
• As of October 1, 2025, all De Novo submissions must use eSTAR format
• eSTAR is now voluntarily available for IDE (Investigational Device Exemption) and PMA 30-Day Notice supplement submissions
• FDA’s 2025 guidance emphasizes that the Q-Sub Program has expanded significantly beyond its initial focus on IDE submissions to include a broad range of submission types
• Enhanced focus on breakthrough device designations and accelerated pathways for innovative technologies

Conclusion

While Japan’s PMDA General Consultation and the United States’ FDA Pre-Submission appear to be similar “early consultation systems” at first glance, their nature, purpose, and positioning differ significantly. General Consultation is positioned merely as a procedural entry point for initial guidance and as a preparatory stage for more detailed consultations. In contrast, Pre-Sub functions as a venue for substantial pre-review discussions including technical and scientific details.

For medical device development companies, particularly those with an eye toward global markets, it is important to understand the characteristics of both systems and strategically utilize them with recognition of the purpose and limitations of each system. In the Japanese market, it is possible to construct an efficient approval application process by utilizing General Consultation as an entry point while systematically combining more detailed face-to-face consultations. In the U.S. market, thorough preparation for Pre-Sub meetings, including technical and scientific details, and effective utilization of FDA’s feedback can significantly streamline the development and approval process.

Both regulatory systems continue to evolve, with increasing emphasis on digital transformation, enhanced transparency through electronic submissions, and accelerated pathways for innovative technologies. Companies should stay informed of these ongoing developments and adapt their regulatory strategies accordingly. The fundamental difference remains that PMDA’s General Consultation serves primarily as an initial orientation and gateway to more substantive paid consultations, while FDA’s Pre-Sub provides comprehensive technical guidance and strategic direction within a single free consultation mechanism.

Understanding these distinctions and utilizing each system appropriately according to its intended purpose will contribute to successful regulatory outcomes in both markets. The key to success lies not only in understanding the procedural differences but also in recognizing the philosophical approaches each regulatory authority takes toward early engagement with industry, and tailoring your consultation strategy to align with these approaches while maintaining the integrity and quality of your development program.