Knowing how to get your 510(k) application through FDA quickly can save millions of dollars in unnecessary time and expense. Mark DuVal, a national authority who speaks and writes frequently on the 510(k) program is in Silver Spring, Maryland at FDA two to three times a month negotiating Pre-Submission, IDE, 510(k), de novo, PMA and combination product issues, as well as planning and executing panel meetings for his clients. He has also filed a Citizen Petition with FDA trying to influence FDA’s administration of the 510(k) program. This event will help attendees have a more solid foundation for understanding the 510(k) program while giving them the tools and insights, tips and tricks needed to obtain a 510(k) that is more likely to get cleared in a timely fashion.
510(k) CONTENT—Making it an Advocacy Document
Mr. DuVal will teach you the basics and advanced knowledge of the 510(k) program. He will also provide insights in what FDA looks for in 510(k) submission and common mistakes companies make in drafting 510(k)s. This will include insights and commentary on CDRH's new proposals for the 510(k) program as well as the impact the new FDASIA legislation has on the 510(k) program. He will also discuss the pluses and minuses of Pre-IDE and Pre-Submission meetings and how to approach them. He will address when and how to deal with adverse 510(k) decisions, whether it is an Additional Information letter or an NSE decision. He will also help you determine how to respond to a request to divert your submission to a Pre-Submission meeting or the de novo path. He will bring examples, derived from the trenches with FDA, which will bring the discussion alive. This will include a workshop in which participants will be given hypotheticals to work on in small groups to share the position they would take in an FDA appeal meeting.
MARKETING YOUR 510(k) DEVICE—dealing with the uncertainty of general vs. specific uses
Mr. DuVal will also spend time on the promotional side of marketing a 510(k) starting with an analysis of how to go to market with a general intended use statement and specific uses (indications) to which the device may be put. He will cover FDA's ''General/Specific Intended Use'' Guidance and the “K86-3 Blue Book Memorandum” and discuss how FDA approaches the interpretation of both using real examples and FDA’s newly proposed 510(k) guidance. He will also discuss promotional issues companies face post-approval, including FDA's enforcement activities with respect to the promotion of general versus specific uses. This will also include a workshop where the participants will again work in small groups to construct a promotional plan for a fictional medical device.
- Understanding the politics of the FDA program
- Knowing the framework for the 510(k) program
- Understanding the correct predicate choice, multiple and split predicates and reference devices
- How to address the definitional skirmishes over whether you have the same intended use, same technological characteristics or raise different questions of safety or effectiveness
- Dealing with the level of performance (non-clinical and clinical) testing needed
- Understanding the difference between what FDA reviewers wants versus what they need
- Responding to Additional Information letters
- Knowing how to apply FDA’s Least Burdensome guidance documents to your advantage
- Dealing with new FDA requirements and guidance documents
- Knowing how to respond to a request to divert to a Pre-Submission meeting or the de novo path
- Discovering how, when and why to negotiate with FDA
- How to do appeals of various decisions if necessary
- Determining how to market a device under a general intended use statement
- Figuring out what to do with more specific indications statements
- Understanding the risks on promoting a specific indication under a general intended use
- What to do if you get a promotional warning letter