Marketing medical devices in the United States
If you intend to export a medical device to the United States, you will be required to submit an application for both notification and approval from the Food and Drug Administration (FDA). You will also be required to register your facilities and comply with the Quality System Regulation (QSR) or Quality Management System Regulation (QMSR) established by the FDA.
There are three required application categories, as listed below.
510(k) submission (premarket notification)
510(k) submission refers to a specific type of premarket notification, which applies to Class I, II, and some aspects of Class III medical devices that do not require a Premarket Approval (PMA) application. When applying to the FDA, you are required to demonstrate that your medical device is substantially equivalent to an already legally marketed device (predicate device) in the United States.
Since October 2023, all 510(k) submissions have been required to be completed through an FDA form called the electronic Submission Template And Resource (eSTAR).
PMA application
PMA stands for Premarket Approval, which refers to the process of obtaining FDA approval in order to market a medical device in the United States. This process applies to Class III medical devices (excluding some devices that are subject to 510(k)). When applying to the FDA, you are required to submit information from non-clinical and clinical trials to demonstrate the device’s effectiveness and safety.
De Novo application
De Novo refers to the classification method for new medical devices with relatively low risk that are not substantially equivalent (NSE) to any existing devices. Devices approved through a De Novo application are assigned a new classification by the FDA, allowing them to serve as predicate devices in subsequent 510(k) submissions.
At SunFlare, we provide comprehensive support for documentation processes, including drafting application forms for 510(k), PMA, and De Novo applications—from the planning and design stages to post-market development—as part of our export assistance to the United States.
Consulting services provided by SunFlare
Support for examining US application strategies
Prior to the application, we provide consulting services regarding the confirmation of existing products in the US market, consideration of the application route, and necessary data.
- Precedent product research
- Support in selecting predicate devices that are essential for demonstrating substantial equivalence
- Consideration of application route (510(k), De Novo, and PMA)
- Investigation of application classification and development of application policies
- Investigation of product classification
- Identification of necessary data package (including sufficient clinical data)
- Standards and guidance research
- Investigation of various standards and guidance related to design inputs and advertising and promotional regulations related to post-market materials
- Examination of application strategies utilizing Q-Submission* (prior consultation system)
- Preparation of consultations and application documents for pre-submission (such as preliminary consultations for 510(k) applications) and support in response to FDA advice
- Q-Submission: Also known as Q-Sub, this term refers to a pre-submission process used by the FDA. Several types of Q-Submissions are available, including pre-submissions such as 510(k) applications. Consultation materials are required to be submitted in writing, while advice may be provided either in writing alone or in writing following a meeting (face-to-face, online, or by phone).
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Compliance with QSR or QMSR*
When establishing a new quality management system or operating an existing one, we will conduct a gap analysis with the existing system.
- Support for the establishment of quality management systems
- Consultation and drafting of quality system procedures, etc.
- Provision of templates for various record formats and QMS on-site seminars
- Support for gap analysis between an existing Quality Management System (QMS) and QSR or QMSR
- Gap analysis between an existing QMS and the requirements of QSR or QMSR
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QMSR: Quality Management System Regulation is an amendment to align the current Quality System Regulation (QSR) by incorporating ISO 13485:2016. It will be included in Title 21, Part 820 of the Code of Federal Regulations (CFR), effective February 2, 2026.
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Preparation of application forms and support for standards compliance
We provide support and consulting for the preparation of application forms and documentation related to standards compliance.
- Application procedures for 510(k) and De Novo
- Lectures on writing
- Drafting on 510(k) and De Novo applications derived from original data
- Support for compliance with software-related guidance
- Support for documentation of each task based on the requirements of FDA guidance, IEC 62304, and IEC 81001-5-1
- Support for compliance with human factors and usability engineering-related guidance
- Support for the establishment and documentation of the usability engineering process
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