Navigating 510(k) and De Novo Requirements
Upcoming Virtual Courses
Upcoming In Person Courses
501(k) submissions have been significantly updated over the past year, and even the past few months. Everyone, including professionals with experience submitting 510(k)s will be able to benefit from the recent updates to this course.
- Access FDA Guidance(s) and databases (e.g., Establishment Registration database) to find information provided by the FDA and public information about other devices that are legally marketed in the USA.
- Identify strategies for dealing with rapidly evolving medical device policies.
- Understand the specific format and content required by the FDA for all 510(k) submissions.
- Describe substantial equiveillance in terms of design, construction, use indications, safety performance, effectiveness, etc.
- Understand the basic requirements for documenting design controls, risk management and human factors validation during device design and development—including software development.
- Understand the FDA 510(k) review process—including eCopy uploads, RTA screening, substantive review, interactive review, and requests for additional information.
- Recognize how to reduce the time to bring new and improved devices to the U.S. marketplace and avoid common mistakes that lead to submission errors, rework, denial and delay of applications using the 510(k) clearance process.
- Understand the various types of pre-submission meetings, and determine how to get the most value from that FDA interaction during the Pre-Submission meeting
- Understand the basic process for registration and listing of a device that is 510(k) cleared, and when that occurs in the overall 510(k) process.
- Understand how to determine and document if device modifications require submission of a new 510(k)
- the De Novo pathway and how to prepare a De Novo submission.
What to expect
- Learn about all the elements and documentation required in a 510(k) submission.
- Plan your design project for 510(k) clearance.
- Reduce time to market through full regulatory comprehension and strategic planning
- Lower your company’s dependence on consultants by bringing the regulatory expertise in-house
Who Should Attend?
Virtual Training Information
Vice President of Quality Assurance, Allotex
Rita Lin, MS, RAC
Director of Human Factors Engineering, Agilis
Rita has effectively managed medical device designs from concept to commercialization. She applies her technical and regulatory backgrounds to coordinate teams across multiple disciplines and departments. Rita has successfully led efforts to develop new digital health products while at Vigor Health, execute design modifications on spine devices while at Stryker, and help clear and approve hundreds of medical devices and combination products while at the FDA.
During her career, Rita has earned several certifications and awards, including the Stryker Innovation award, FDA Quarterly awards, Six Sigma Green Belt, and RAC. She is also expert faculty for the AAMI Human Factors for Medical Devices and 510k/De Novo training courses, and is a recurring speaker for the Human Factors and Ergonomics Society and Clemson University College of Engineering.
Rita graduated from Duke University with a Bachelor’s and Master’s degree in Biomedical Engineering.