510(k) Submissions to the FDA: Hands-On Workshop

Date: July 24-25, 2025
Time: Starts at 10 AM EST
Duration: 2 Days

Each year FDA receives about 3000 applications for new devices via the 510k process, and about 60% of them are rejected either for poor quality application that cannot even be reviewed or for other technical reasons. Submissions to the FDA that are poorly organized, do not follow current practices, contain inconsistencies between documents, have missing or incomplete content, or poor structure will result in significant delays in the clearance process. With multiple review cycles, up to 90 days each, rejections by FDA could stretch the 510k clearance time-lines to 8 months or more. Most of the refuse-to-accept deficiencies are due to the inexperience of the 510k writers, who ignore the FDA rules. Writing and assembling a complete and well structured 510(k) submission will certainly improve the likelihood of FDA clearance on the first round.

This hands-on workshop is done by one of the industry’s top regulatory expert. The trainer has performed numerous reviews of 510(k) submissions over the last 15 years, and has analyzed the reasons that most often lead to delays in getting submissions ultimately cleared by FDA. This hands-on workshop will walk the attendees through the structure and key elements of the 510(k) submission and explains in clear language the most common pitfalls to avoid in the development of your 510(k) submission to the FDA.

Who will benefit:

  • Class I and Class II medical device developers
  • Regulatory affairs personnel
  • Medical writers and technical writers
  • CEO, COOs, Operations Managers for medical device companies
  • People investing in or developing medical devices for FDA approval

Speaker: Mukesh Kumar

​PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Day One (10:00 AM - 3:30 PM EST)

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 EST)

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

Register Online (By clicking on the links below)

Single

Individual

$ 1199

Corporate

5 People

$ 3999

Corporate

10 People

$ 7999

​​Prices are in US Dollars.

The registration fee includes the workshop and all related course materials.

Terms & Conditions to register for the Workshop
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this seminar, please email us at info@fdamap.com

Payment:
We accept credit card, debit card, and PayPal.

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 20 working days prior to the start date of the event will receive a refund — less a $200 administration fee per person. No cancellations will be accepted — nor refunds issued — within 20 working days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future FDA Map event and a credit note will be issued.

For more info, fill the box below. We will contact you within 24 hrs.