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eSTAR 510(k)The Optimal Way to Assemble a Successful eSTAR 510(k)
An In-Depth & updated Guide from a Former FDA Reviewer of Medical devices submissions
Since FY2024, FDA has required 510(k) premarket notifications to comply to eSTAR requirements. These new requirements have made an already daunting process even more confusing and challenging. This course, given by a former FDA reviewer turned consultant, provides
- the overall framework of US medical device regulation
- a detailed walkthrough of all sections of a eSTAR 510(k)
- a focus on...Continue reading
Have a question? We have the answer
Issues to be covered
- Introduction
- Regulatory Background
- Device classes
- Device regulations and procodes
- 510(k)s and Substantial equivalence
- Types of 510(k) Submissions
- Timeline
- eSTAR
- What is it
- Advantages / Disadvantages
- Integration of guidance and special controls
- CDRH portal
- Traditional 510(k)
- Cover Letter / Letter of Reference
- 510(k) Summary
- Device description
- Substantial equivalence argument
- Draft labeling
- Reprocessing, Sterility, and Shelf-life
- Biocompatibility
- Software
- Software documents
- Cybersecurity
- Interoperability
- Electrical Testing
- EMC testing
- Wireless Technology
- Electrical Safety
- Performance testing
- Bench Testing
- Animal Testing
- Clinical testing
- References
- Administrative Documents
- Executive summary (Optional)
- 510(k) Summary
- User fee
- Special 510(k)
- Eligibility
- Timeline
- Content as compared to traditional 510(k)
- Responding to Requests for Additional Information (RAI)
- Types of RAI
- Response options
- SIM
- Interactive
- Withdrawal
- Working well with FDA
- Formal Response
- Actual review times
- De Novo Downclassification
- Difference in marketing submission
- History
- Content (as compared to traditional 510(k))
- Benefit Risk
- Actual review times
- Changes to the device after clearance
- When to submit a new 510(k)
- Letter to FIle
Who should attend
- Regulatory affairs professionals
particularly individuals who are or will be involved in the drafting of a eSTAR 510(k) submission in the near future - Quality controls managers & personnel
Benefits to the Participants
After this course, the participant should:
- understand FDA’s framework for medical device regulation
- understand FDA’s review process and timelines for 510(k)s
- have working knowledge of the content of eSTAR 510(k)s and what information FDA focuses on in each section
- understand what types of changes can and cannot be made without permission from FDA
About The Lecturer
