Understanding the 510(k) Premarket Notification
Learn how the FDA’s 510(k) premarket notification system facilitates the introduction of new medical devices to the market, ensuring safety and compliance.
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Understanding the 510(k) Premarket Notification
The Critical Role of FDA's 510(k) System in Medical Device and Pharmaceutical Regulation
The FDA’s 510(k) process is a pathway for the clearance of moderate-risk medical devices, so that they can be marketed and sold on the U.S. market. The term 510(k) refers to the section in the federal Food, Drug & Cosmetic Act that provides program requirements, and is also known as a premarket notification. Following is a breakdown of how it typically works:
Submission
The process starts when a manufacturer submits a 510(k) premarket notification to the FDA. The marketing application must be submitted electronically using FDA’s eSTAR system (https://medicaldevicesandpharma.com/estar-electronic-510k-submissions/). This submission includes detailed information about the medical device, such as its intended use, design, materials, labeling, packaging, and manufacturing processes.
Predicate Device Comparison
The submission compares the device to be cleared (known as the “new” or “subsequent” device) to a comparison of one or more similar devices already legally marketed in the United States. These legally marketed devices are called “predicate devices.” The comparison must demonstrate that the new device is substantially equivalent to the predicate device(s) in terms of intended use, technological characteristics, and safety and effectiveness.
Substantial Equivalence Determination
If the FDA determines that the new device is substantially equivalent to the predicate device(s), the clearance process may proceed. Substantial equivalence does not mean identical; rather, it means that the new device has the same intended use and does not raise different questions of safety and effectiveness than the predicate device.
FDA Review Processes
The FDA reviews the 510(k) submission to ensure that it contains all required information and that the device is indeed substantially equivalent to the predicate device(s). This review process typically takes months, although the timeline can vary depending on the complexity of the device and the completeness of the submission.
The FDA’s review of premarket notification 510(k)s involves several key steps:
Acknowledgement of Receipt
Upon receiving a 510(k) submission, the FDA assigns it a unique control number (K number) and conducts verification checks for proper user fee payment and submission format (eSTAR or eCopy). If issues arise, a Hold Letter is sent, giving the submitter 180 days to resolve them. If everything is in order, an Acknowledgment Letter is sent to the submitter with the receipt date and K number.
Format and Submission Acceptance Review
For eSTAR submissions, a virus scan and technical screening process are conducted. If incomplete, the FDA notifies the submitter, who has 180 days to provide a complete replacement. For eCopy submissions, the Lead Reviewer conducts an Acceptance Review using the appropriate checklist. The 510(k) is then routed to the appropriate office and assigned to a Lead Reviewer.
Substantive Review
The Lead Reviewer conducts a comprehensive review of the submission. Within 15 days of receipt, the submitter receives notification of the Acceptance Review result. If accepted, the submission proceeds to Substantive Review. If not accepted, it’s placed on RTA Hold, and the submitter has 180 days to address deficiencies.
Substantive Interaction and Interactive Review
During Substantive Review, the Lead Reviewer communicates with the submitter through a Substantive Interaction, typically within 60 days of receipt. This may involve proceeding to resolve outstanding deficiencies via Interactive Review or issuing an Additional Information (AI) request, placing the submission on hold.
Interactive Review
If an Interactive Review is chosen, the Lead Reviewer communicates with the submitter to address outstanding deficiencies. Additional information may be requested, and responses must be submitted within the specified timeframe.
Additional Information (AI) Request
If deficiencies remain after Interactive Review, an AI Request is issued, and the submission is placed on hold. The submitter has 180 days to provide a complete response. Failure to do so within the timeframe results in withdrawal of the submission.
510(k) Decision Letter
The FDA aims to make a MDUFA Decision within 90 FDA Days. SE decisions result in clearance, and the decision letter is sent to the submitter via email.
If the device is not cleared, the FDA provides a reason for the decision and may request additional information or modifications from the manufacturer.
If the FDA does not reach a decision within 100 FDA days, a Missed MDUFA Communication is issued.
Throughout the process, the FDA follows MDUFA performance goals, and submitters can track the progress online.
Read more
Read more details about the FDA’s 510(k) review process here.
Post-Market Surveillance
Once the device is on the market, the manufacturer is required to monitor its performance and report any adverse events or problems to the FDA. This post-market surveillance helps ensure the continued safety and effectiveness of the device.
Conclusion
It is important to note that the 510(k) process is for moderate-risk devices and is different from the premarket approval (PMA) process, which is required for high-risk devices.
Are you planning to market a new moderate-risk medical device in the United States? We can help. Read more about our 510(k) services here.
Submitter Responsibilities in the 510(k) Submission Process
One of the pivotal roles in the 510(k) submission process is held by the submitter, whose primary responsibility is to ensure that all documentation is accurate, complete, and thoroughly supports the claim that the device is as safe and effective as a legally marketed device. This involves a detailed comparison of the new device with one or more predicate devices.
The submitter must gather substantial evidence, including scientific and clinical data, to demonstrate equivalence. This comprehensive documentation must adhere to the FDA’s stringent guidelines and is critical for the subsequent review phases. Failure to provide clear and precise information can lead to delays or rejection of the submission.
Moreover, the submitter is also responsible for maintaining open lines of communication with the FDA during the review process. This includes promptly addressing any queries from the FDA regarding the submission and providing additional information if required, ensuring a smoother and more efficient review process.
Understanding FDA's 510(k) Review Stages
Key Phases in FDA 510(k) Approval Process
The FDA’s 510(k) submission process is a critical pathway for medical device manufacturers aiming to enter the U.S. market. This process involves several key stages, starting with the preparation and submission of a premarket notification to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. Following submission, the FDA conducts an initial administrative review to ensure completeness of the application. If the submission meets these criteria, it progresses to a substantive review where detailed evaluations of the device’s safety and effectiveness are conducted. The final decision stage culminates in either clearance, additional information request, or rejection of the 510(k) submission.
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