Most medical devices in the US today are marketed under the premarket notification (510(k) authorities of the Federal Food, Drug, and Cosmetic Act. In order to market some types of Class I and most Class II devices in the US, you need to submit a 510(k) submission to FDA and receive FDA clearance. While the underlying data used to support the 510(k) submission may be similar to what is required in other jurisdictions, the regulatory requirements and the submission process are very different. The purpose of this workshop is to provide participants with an understanding of the regulatory fundamentals; practical guidance on how to develop, prepare and submit a 510(k) to FDA; and how to engage with FDA.
15 November 2018 (9:00 am – 4:00 pm)
16 November 2018 (9:00 am – 3:00 pm)
New York New York Hotel
3790 Las Vegas S Boulevard
Las Vegas, Nevada 89109
: 8 November 2018
: 16 October 2018
: 10 RAC recertification credits upon completion of the programWill this meeting be recorded
Proof of Attendance
: An electronic letter of attendance will be sent upon request.
: Registration until 16 October 2018
Nonmembers: $1,150 Registration from 17 October 2018 to 8 November 2018
Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited so register early for this program.
After this program, participants will be able to:
• Describe the regulatory framework and introduction to 510(K)
• Develop the underlying data and documentation needed to support a 510(k) submission
• Prepare a 510(k) submission with all required sections through the submission phase.
• Interact confidently with FDA during the 510(k) review process including what to do if things go wrong. Who Should Attend
This program would be appropriate for individuals who have never submitted a 510(k) and those who have some experience and are looking to sharpen their skills.
• FDA Medical device regulatory framework and introduction to 510(k)
• Developing a regulatory strategy
• Developing underlying documentation, including biocompatibility, sterilization, software, electrical and EMC testing, bench testing
• Preparing your 510(k) submission
• Interacting with FDA during the 510(k) review process
• Device changes after clearance
: Program content may vary.
, President, Infinity Biomedical Group, LLC Donna-Bea Tillman
, Ph.D., FRAPS, Team Leader and Senior Consultant, Medical Devices, Biologics Consulting
Attendees must bring their own laptops. RAPS does not provide equipment for attendees.
If it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. If you or your company will mail a check for payment, please include a completed registration form for the participant. Questions
Call RAPS Solutions Center at +1 301.770.2920, ext. 200.
: 16 October 2018
: RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
+1 301 770 2920, ext. 291
RAPS has secured a limited number of discounted rooms at the New York New York Hotel for workshop attendees. The room block is now closed, but you may contact the hotel directly to make a reservation at 866.815.4365. Be advised that current room rates also include a daily + $37.00 per day resort fee, plus all applicable room taxes. Hotel FAQ - transportation, check-in policies, etc.
All cancellation requests must be submitted to email@example.com by 16 October 201
8. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed.
Substitutions may be accepted with written approval from RAPS and must be submitted to firstname.lastname@example.org by 1 November 2018
If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at email@example.com.
: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.