Overview                              Detailed Agenda                               Speaker                                        Price/Registration                 

Course Agenda - Eastern Standard Time
Day One (10:00 AM - 3:30 PM)

10:00 AM – 11:00 AM: The Law and Regulations
  • The legal basis for a 510(k): The potential consequences  of not submitting a 510(k)
  • Different  types of 510(k)s
  • How to determine if a 510(k) is needed
  • How to select the appropriate  type of 510(k)s
  • Review  of bundling 510(k)s
  • The 513(g)​​​

11:00 AM – 12:00 PM: Strategy and Planning
  • Factors to consider when developing  a strategic and regulatory  plan
  • How to define the role of the regulatory  professional
  • How to use FDA guidance when planning and organizing  the 510(k)
  • Risk Assessment and strategic presentation

12:00 PM – 12:30 PM: Break

 12:30 PM – 2:00 PM: Assembling  the 510(k)
  • How to select a predicate device
  • How to collect and organize the data and actually prepare  the 510(k)
  • Standards  Data Report
  • Potential  Pitfalls

2:00  PM– 2:15 PM: Break

2:15 – 3:30 PM: Assembling  the 510(k) (Continued)
  • Sections of the 510k application
  • Best Practices for filling the 510(k) checklist
  • The traditional and e510k format of application
  • Gap Analysis and 510k strategy
Day Two (10:00 PM - 2.00 PM)

10:00 AM – 11:00 AM: FDA’s 510(k) Refuse to Accept
  • What happens once you submit the 510k
  • FDA’s internal review process for new 510k
  • Discussion of the “Refuse  to Accept” checklist
  • Common reasons for rejection and potential solutions

11:00 AM – 12:00 PM: The FDA Review Process
  • The review  process for traditional 510(k)s
  • Interacting with FDA before and during  the review  process
  • The role of the regulatory  professional  in resolving  disputes
  • How the FDA “holds” process work
  • Tips and hints
 
12:00 – 12:30 PM: Break

12:30 – 2:00 PM: 510(k)  Post-Clearance  Process
  • Deciding when to submit a new 510(k) for a device  modification
  • Obtaining  information  about another company’s devices
  • Modifications
  • Life cycle considerations
  • Promotional  practices
  • Post-clearance  exercise