510(k) Premarket Notification
Premarket Notification Submission
Legal Requirement: This regulation is legally binding and must be complied with for US market access. Non-compliance can result in regulatory action, including warning letters, import detentions, and product recalls.
Overview
Scope
510(k) Premarket Notification is a premarket submission made to FDA to demonstrate that a medical device is substantially equivalent to a legally marketed device (predicate device). Most Class II medical devices require 510(k) clearance before marketing in the US. The submission must demonstrate that the new device is as safe and effective as the predicate device.
Applicability
510(k) submissions are required for most Class II devices and some Class I devices (those not exempt from premarket notification). Class III devices typically require PMA, not 510(k). The 510(k) pathway is available when there is a legally marketed predicate device to which substantial equivalence can be demonstrated.
Why It Matters
510(k) clearance is required for most medical devices before they can be legally marketed in the US. Without 510(k) clearance, devices cannot be sold or distributed. The 510(k) process allows FDA to review devices for substantial equivalence, ensuring safety and effectiveness while facilitating market access for new devices. Non-compliance can result in FDA enforcement actions including warning letters, import detentions, and product seizures.
Key Concepts
- Substantial equivalence to predicate device
- Indications for use comparison
- Performance data and testing
- eSTAR electronic submission format
- 90-day review timeline (may be longer)
- Special controls and standards compliance
- Software documentation requirements
- Biocompatibility and sterilization data
- Labeling requirements
Most Class II devices go through 510(k). Understanding this process is fundamental to US market access.
The 510(k) is the most common pathway for medical device clearance. The key: demonstrate substantial equivalence to a predicate device that's already legally marketed. Choose your predicate wisely. A good predicate comparison is the foundation of your entire submission.
🔑 Key Takeaways
- →Use eSTAR—it's faster to prepare and FDA reviews it more quickly.
- →Pre-Sub meetings with FDA are free and can save months of back-and-forth.
- →Missing NRTL test reports is the #1 cause of additional information requests.
- →FDA's 90-day review clock doesn't include the time they're waiting for your responses.
— ER | medev.ai
Building better devices, together.
510(k) Submission Requirements
Substantial Equivalence
The core requirement is demonstrating substantial equivalence to a predicate device. This means the new device has the same intended use and either: (1) the same technological characteristics, or (2) different technological characteristics that do not raise new questions of safety and effectiveness and demonstrate equivalent safety and effectiveness.
Device Description
Provide detailed description of the device including design, materials, components, and specifications. Include diagrams, photographs, and technical drawings. Describe how the device works and its key features.
Indications for Use
Clearly state the intended use, indications for use, and target patient population. Compare to predicate device indications. Any expansion of indications may require additional data or clinical studies.
Substantial Equivalence Comparison
Provide side-by-side comparison with predicate device(s) including: intended use, technological characteristics, performance specifications, materials, design features, and labeling. Explain any differences and why they don't raise new safety/effectiveness questions.
Performance Data
Include all testing data demonstrating safety and effectiveness: electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), laser safety (IEC 60825-1, IEC 60601-2-22), software validation (IEC 62304), usability (IEC 62366), biocompatibility (ISO 10993), and performance testing. Include NRTL test reports and certificates.
Software Documentation
For devices with software, provide software documentation per IEC 62304 including: software safety classification, software development plan, software requirements, architecture, verification and validation, and cybersecurity documentation.
Labeling
Include all labeling: device labels, instructions for use, user manual, and any promotional materials. Labeling must comply with 21 CFR 801 and include required warnings, precautions, and use instructions.
Truthful and Accurate Statement
Include statement that all information is truthful and accurate, signed by authorized representative. False statements can result in criminal penalties.
510(k) Submission Process
Determine Regulatory Pathway
Confirm device requires 510(k) and identify appropriate predicate device(s). Review FDA device classification database. Consider Pre-Submission meeting with FDA to discuss pathway.
Prepare eSTAR Submission
Download latest eSTAR template from FDA website. Use eSTAR for structured submission format with validation checks. Complete all required sections including device description, predicate comparison, and performance data.
Complete Performance Testing
Conduct all required testing: electrical safety (NRTL), EMC (NRTL), laser safety (if applicable), software validation, usability, biocompatibility. Ensure test reports are complete and include all required data.
Prepare Substantial Equivalence Comparison
Provide detailed side-by-side comparison with predicate device(s). Explain any differences and demonstrate they don't raise new safety/effectiveness questions. Include performance data comparison.
Complete Software Documentation
For devices with software, provide complete IEC 62304 documentation including safety classification, development plan, requirements, architecture, verification/validation, and cybersecurity documentation.
Finalize Labeling
Prepare all labeling including device labels, instructions for use, user manual. Ensure compliance with 21 CFR 801. Include all required warnings, precautions, and use instructions.
Submit Through ESG
Submit eSTAR-generated PDF through FDA Electronic Submission Gateway (ESG). Ensure ESG account and credentials. Keep submission confirmation and tracking number.
Respond to FDA Questions
Monitor submission status. Respond promptly and completely to any FDA requests for additional information. Consider teleconference to clarify questions. Delayed responses extend review timeline.
Common Challenges & Solutions
Incomplete test reports or missing NRTL certificates
Ensure all testing is completed before submission. Obtain NRTL certificates for electrical safety and EMC. Include complete test reports with all required data.
Insufficient substantial equivalence justification
Provide detailed comparison with predicate device. Explain all differences and demonstrate equivalent safety/effectiveness. Include performance data comparison.
Missing software documentation
Provide complete IEC 62304 documentation including safety classification, development plan, requirements, verification/validation. Include cybersecurity documentation if applicable.
Related Regulations
21 CFR Part 807
Establishment Registration and Device Listing
Required before marketing device
21 CFR Part 820
Quality System Regulation
QMS requirements for device development
PMA Submission
Premarket Approval
Alternative pathway for Class III devices
21 CFR Part 812
Investigational Device Exemptions
Required for clinical studies
Related Standards
Resources
Official Resources
Implementation Tools
Legal Notice: This page provides implementation guidance and educational content only. The actual regulation text is the legally binding document. Always refer to the official regulation published in the Code of Federal Regulations (CFR) and FDA guidance documents for compliance purposes.