510(k) Submission Services
Regulatory Strategy Development
- Evaluation of device classification and determination of 510(k) pathway
- Strategic planning for submission, including timeline and requirements
- Guidance on determining substantial equivalence to a predicate device
Pre-Submission Consultation
- Interaction with the FDA for pre-submission meetings (e.g., Pre-Sub)
- Preparation and submission of pre-submission documents
- Addressing FDA feedback and incorporating it into the submission strategy
510(k) Application Preparation
- Compilation of necessary documentation, including device description, intended use, and technological characteristics
- Preparation of performance data and clinical study reports (if applicable)
- Drafting and organization of submission components such as labeling, risk analysis, and user needs
Technical Writing and Documentation
- Development of detailed and accurate technical documentation
- Preparation of the 510(k) summary or 510(k) statement
- Creation of labeling, instructions for use (IFU), and device manuals
Testing and Validation Support
- Coordination of required bench testing, biocompatibility studies, and other validation activities
- Assistance with obtaining and interpreting test results
- Ensuring testing meets FDA requirements for the 510(k) submission
Regulatory Compliance Check
- Review of all submission components to ensure compliance with FDA guidelines
- Verification that all required elements are included and properly documented
- Identifying and addressing any compliance gaps before submission
Submission Management
- Preparation and electronic filing of the 510(k) submission through the FDA’s electronic system (eSubmitter or others)
- Tracking submission status and communicating with FDA reviewers
- Managing follow-up communications and responses to FDA queries
FDA Interaction and Communication
- Handling FDA inquiries and additional information requests
- Managing discussions and negotiations with FDA reviewers
- Providing timely responses to FDA’s additional information requests (AI)
Review and Approval Support
- Assisting with understanding and addressing any issues raised during FDA review
- Supporting the preparation of additional data or documentation if required
- Coordinating and facilitating the FDA’s final review and decision
Post-Submission Support
- Assistance with addressing any conditions or requirements imposed by FDA upon clearance
- Guidance on post-clearance activities and compliance
- Support for preparing for potential audits or inspections related to the 510(k) submission
Regulatory Updates and Alerts
- Providing updates on changes to 510(k) requirements and FDA guidelines
- Alerting clients to any new regulations or procedures affecting 510(k) submissions
Training and Education
- Training for internal teams on 510(k) submission processes and requirements
- Workshops on best practices for preparing and managing 510(k) submissions