The Basics of 510(k) and Working With FDA

When:  Apr 24, 2018

Most medical devices in the U.S. today are marketed under the premarket notification (510(k) authorities of the U.S. Federal Food, Drug, and Cosmetic Act.  In order to market some types of Class I and most types of Class II devices in the United States, 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.

At a Glance
Program Dates: 24 April 2018 (9:00 am–16:30 pm)
25 April 2018 (9:00 am–16:30 pm)

Meeting Location: Hilton Garden Inn Custom House
1 Custom House Quay, North Dock,
Dublin
Ireland
Hotel Website

Registration Closes: 17 April 2018 
Refund Deadline: 25 March 2018
RAC Credits: 10 RAC recertification credits upon completion of the program
Will this meeting be recorded? No
Proof of Attendance: An electronic letter of attendance will be sent upon request.

Registration Fees: Registration to 26 March 2018
RAPS Members:  $1,050 (€857.26 as of 1/17)
Nonmembers:  $1,150 (€938.90 as of 1/17)

Registration from 27 March 2018 to 17 April 2018
RAPS Members:  $1,150 (€967.81 as of 1/17)
Nonmembers:  $1,250 (1020.54 as of 1/17)

Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people.

Objectives & Audience
Objectives

After this program, participants will be able to:

  • Describe the regulatory framework behind FDA’s classification of medical devices
  • Develop the underlying data and documentation needed to support a 510(k) submission
  • Prepare a 510(k) submission with all required sections
  • Interact confidently with FDA during the 510(k) review process

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.

Agenda

  • 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

NOTE: Program content may vary.

Faculty
Heather Rosecrans, FRAPS, Executive Vice President, Medical Devices & Combination Products, Greenleaf Health
Daniel Schultz, MD, FACS, Principal, Medical Devices and Combination Products, Greenleaf Health
Donna-Bea Tillman, Ph.D., FRAPS, Team Leader and Senior Consultant, Medical Devices, Biologics Consulting

Registration Info

IMPORTANT: Attendees must bring their own laptops. RAPS does not provide equipment for attendees. Apple computers are discouraged.

Registration to 26 March 2018
RAPS Members:  $1,050 (€857.26 as of 1/17)
Nonmembers:  $1,150 (€938.90 as of 1/17)

Registration from 27 March 2018 to 17 April 2018
RAPS Members:  $1,150 (€967.81 as of 1/17)
Nonmembers:  $1,250 (1020.54 as of 1/17)

Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people.
» Registration Online
» Registration Form (PDF) for registration by mail or fax
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.

Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200.
Refund Deadline: 25 March 2018

Other Information
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.

Program Contact
Nichelle Sankey
nsankey@raps.org
+1 301 770 2920, ext. 291

Logistics Contact
Wessel Nieuwenweg
wnieuwenweg@raps.org
+33 9 67 62 61 04

Area Airport
Dublin Airport is 12 kilometers from the hotel and approximately a 20 minute drive. Average taxi fare is 25 EUR and bus service is available for as little as 6 EUR.

Driving Directions
From the M1 continue on to the Swords Road. Follow the signs towards city centre and the hotel is located on Custom House Quay.

Parking
Limited parking is available at the hotel at a fee of approximately 18 EUR per day in a public car park.
 
Additional maps and information about how to reach the hotel can be found via the following website.

Taxi

Making use of a taxi service is a convenient way to travel to Dublin’s city centre. Traveling from the Airport to the hotel by taxi will take approximately 20 minutes, provided that traffic conditions are reasonable, and will cost approximately 25 Euros.  Taxis are readily available outside the arrival are of the Airport.

Hotel Accommodation

RAPS has secured a discounted room block at the Hilton Garden Inn Custom House for workshop attendees. Please mention that you are participating in the RAPS workshop on 24-25 April 2018.

Check-in time is 15h00. Although the hotel will make every reasonable effort to accommodate guests who arrive before the check-in time, the client recognizes that guest rooms may not be immediately available. Baggage storage will be available. The hotel check-out time is 12.00 on the day of departure.

Room Rate: € 200.00 per night (including TAX)

Room Rate includes:

  • Complimentary breakfast
  • Free WIFI Internet for all inhouse guest
  • Tax (VAT)

Cancellation
All cancellation requests must be submitted to raps@raps.org by 25 March 2018. 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 raps@raps.org by 10 April 2018.

If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.

NOTE: 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.


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Location

1 CUSTOM HOUSE QUAY
Dublin 1, D01 KF84