The Basics of 510(k) and Working With FDA


510 K
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
  • Objectives & Audience
  • Agenda
  • Faculty
  • Registration Info
  • Cancellation

At a Glance

Date:

13 November 2017 (9.00–16.30)
14 November 2017 (9.00–16.00)

Meeting Location:

Imperial Riding School Renaissance Vienna Hotel
Ungargasse 60
1030 Vienna 
Austria

T: +43 (0)1 711 75 0

Registration Closes:

6 November 2017  

Refund Deadline:

14 October 2017  

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 14 October 2017
RAPS Members:  $1,050 (€883.65 as of 8/30)
Nonmembers:  $1,150 (€967.81 as of 8/30)

Registration from 15 October 2017 to 6 November 2017
RAPS Members:  $1,150 (€967.81 as of 8/30)
Nonmembers:  $1,250 (1051.97 as of 8/30)

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

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 HeadshotHeather Rosecrans - Brought on by FDA in 2006 to direct the full implementation of the administrative and regulatory policy for the 510(k) and 513(g) programs, which included the classification and reclassification programs within the CDRH through 2010. Currently managing the review of 510(k) submissions, regulatory and policy guidance, and strategic consultation on issues related to FDA’s regulation of medical and combination devices as executive vice president at Greenleaf Health.

 

 

 

 


Dan Schultz HeadshotDan Schultz – Former center director for the FDA CDRH, which is responsible for development, implementation and evaluation of regulatory policies concerning medical devices and radiation emitting products. Currently offering client oversight with Greenleaf Health in the regulatory guidance realm, including pre- and post-market settings, with specific emphasis on insight regarding the FDA regulatory process, labeling requirements and potential regulatory actions for medical devices.

 

 

 

 


Donna-Bea Tillman – Former director FDA/CDRH, Office of Device Evaluation, whose primary objectives included managing clinicians responsible for the premarket review of medical devices in the US. Currently advising clients on short and long term regulatory strategies for medical devices and combination products, including the regulatory requirements that may apply to software used in a medical environment. Focus also includes assisting with the development of medical device regulatory submissions that include 510(k), PMA, HDE, RFD, 513(g), preSub, and IDE at Biologics Consulting.

 

Registration Info

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

Registration to 14 October 2017
RAPS Members:  $1,050 (€883.65 as of 8/30)
Nonmembers:  $1,150 (€967.81 as of 8/30)

Registration from 15 October 2017 to 6 November 2017
RAPS Members:  $1,150 (€967.81 as of 8/30)
Nonmembers:  $1,250 (1051.97 as of 8/30)

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: 14 October 2017

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
+301 770 2920, ext. 291

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

Area Airports and Transportation
Vienna Flughafen (Airport) is 17 kilometers from the hotel. Express trains from the airport are available to Central Vienna. For maps and detailed instructions click here.

Driving Directions
Highway A4 from airport, direction Vienna Zentrum - exit Prater/Erdberg - turn left into Schlachthausgasse and continue straight until third set of traffic lights. Turn right into Rennweg and continue until you reach main crossing of Ungargasse. Turn right and the hotel is on your left after 150 m.

Parking
Limited parking is available at the hotel at a fee of approximately €32 per day.

Additional information about how to reach the hotel by public transportation can be found via the following website.

Taxi
Making use of a taxi service is a convenient way to travel to Vienna’s city centre. Traveling from Vienna International Airport will take approximately 20 minutes, provided traffic conditions are reasonable, and will cost approximately €36. Taxis are readily available outside the arrival are of the Airport. 

Hotel Accommodation 
RAPS has secured a discounted room block at the Imperial Riding School Renaissance Vienna Hotel for workshop attendees. To receive the discounted rate, bookings can be made by 29 October. Please mention that you are participating in the RAPS workshop on 13–14 November. Book your group rate for the RAPS Workshop.

Check-in time is 15:00. Although the hotel will make every reasonable effort to accommodate guests who arrive before the check-in time, guests should recognize 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: €119.00 per night (including TAX)

Room Rate includes:

  • Complimentary breakfast buffet
  • Free WiFi Internet for all inhouse guest
  • Tax

Cancellation

All cancellation requests must be submitted to raps@raps.org by 14 October 2017. 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 30 October 2017.

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.