FDA’s Refuse to Accept Policy – How to Prepare 510 (K) Submission to Avoid the Pitfalls of the Policy: 2-day In-Person Seminar

By: James Barley, Regulatory Affairs and Quality Assurance Consultant
Location :- Tampa, FL | Thursday, March 24, 2016 | Friday, March 25, 2016

We need the below information to serve you better

Course Description:

Each year the FDA receives approximately four thousand 510(k) Notifications per year. In the last few years the FDA has made significant changes to the 510(k) Notification process should as the institution of the FDA’s Refuse to Accept Criteria for a 510(k) Notification submission and limiting the number of predicate devices that can be used to show substantial equivalence. Obtaining market clearance in a timely manner allows a company to bring new or improved products to market sooner.

This 2 day course will detail the requirements of a 510(k) submission. The course is interactive and each participant is encouraged to ask questions about specific products. The contents and rational for submitting a traditional, abbreviated and special 510(k) for a Class II Medical Device will be detailed. In addition, comparison tables to show substantial equivalence will be reviewed.

Upon receipt of a 510(k), the FDA reviews the 510(k) within 15 days as part of the Refuse to Accept Policy to verify that all of the required elements are included in the 510(k) submission. This course will review the FDA’s Acceptance Checklist for 510(k) s that the FDA uses for the Refuse to Accept Review and also provide helpful hints for passing the FDA’s initial review.

Learning Objectives

Upon completing this course participants will understand:

  • Difference between a traditional, abbreviated and special 510(k) and when to submit each type of 510(k)
  • When to file for a new device, a change in the intended use or a change in the technology of a cleared device
  • What is contained in a traditional, abbreviated and special 510(k) submission package
  • The submission package, user fees and making an eCopy
  • What is substantial equivalence and what’s required to show substantial equivalence
  • What’s required on the labeling and IFU
  • Which performance tests should be conducted and how to present the data to the FDA
  • The requirements for a risk management plan and report
  • Understand the FDA’s Refuse to Accept Policy
  • What is required in a submission for software controlled devices
  • How and when to use third party reviews
  • When clinical data may be required

Who Will Benefit:

This course is designed for individuals who are tasked with preparing a 510(k) Notification or part of a team preparing a 510(k) Notification. The following personnel will benefit from the course:

  • Company CEOs and Presidents
  • Regulatory Affairs Managers
  • Quality Assurance Managers
  • Regulatory and Quality Assurance Professionals
  • Design Engineers
  • Quality Engineers
  • Legal Professionals

Course Outline

Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
  • The 510(k) regulation
  • Types of 510(k) submissions
    • Traditional
    • Abbreviated
    • Special
  • Preparation of a Traditional 510(k)
    • Substantial equivalence
    • Labeling requirements
    • Performance testing
    • Substantial equivalence testing
    • Risk management documentation
    • When are clinical trials required
  • The submission process
    • User Fees
      • Payment
      • Medical Device User Fee Cover Sheet
    • Submission package
    • eCopy
Day Two (8:30 AM – 4:30 PM)
  • Special 510(k)
    • Why submit a special 510(k) versus a traditional or abbreviated 510(k)
    • Preparation of a special 510(k)
      • Detailing the medical device modification
      • Comparing the cleared device to the modified device
      • Performance testing
      • Comparison testing
      • Labeling requirements
      • Risk management documentation
    • Submission package
  • Abbreviated 510(k)
    • Preparation of an abbreviated 510(k)
      • Guidance documents, special controls and FDA recognized standards
    • The submission process
      • Submission package
      • Substantial equivalence
      • Performance testing summary
    • Submission package
  • FDA’s refuse to accept policy
    • Acceptance checklist for traditional 510(k)’s

Meet Your Instructor

James Barley
Regulatory Affairs and Quality Assurance Consultant

James Barley is a founder of Abrimed Consulting Services, a Medical Device Regulatory Affairs and Quality Assurance Consulting company. Mr. Barley graduated from Lowell Technological Institute with a degree in Engineering and later earned his Masters of Business Administration from Pepperdine University. During the last 20 plus years, Mr. Barley has been consulting for small and medium sized medical device companies. These services included setting up quality systems compliant with the FDA’s Quality System Regulation, ISO 9001 and ISO 13485.

In addition, Mr. Barley has prepared 510(k) submissions for instruments, disposables, electronic equipment and software as well as Technical Files for Class Im, 1s, IIa and IIb. Since the FDA has begun enforcing its Refuse To Accept Policy, Mr. Barley has successfully navigated through the requirements of the FDA Policy.


Location :
Tampa, FL (Venue to be announced shortly)

March 24-25, 2016
Register Online

Register Online

Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both days.
For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.

Group Registrations

Send Your Team for Maximum Benefit Get your team up to speed!

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

  • 2 Attendees
  • 3 to 6 Attendees
  • 7 to 10 Attendees
  • 10+ Attendees
  • -
  • -
  • -
  • -
  • Get 10% off
  • Get 20% off
  • Get 25% off
  • Get 30% off
Call Toll Free +1-1-888-771-6965 if you have any queries.

Register by Wire Transfer

If you wish to pay by wire transfer: Please call us at
Toll Free +1-1-888-771-6965

Download Registration Form

Yes, I want to attend "FDA's Refuse to Accept Policy - How to Prepare 510 (K) Submission to Avoid the Pitfalls of the Policy: 2-day In-Person Seminar"
Click here to Download Registration Form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303

Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ editor@grcseminars.com


Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar 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 GRC Seminars event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:

After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:

By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

Media Partners

If you wish to partner with us for this event please contact us: partner@grcseminars.com or call us: +1-888-771-6965.
Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.
Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.


If you wish to sponsor this event please contact Cruise Webster: cwebster@complianceonline.com or call us: (207) 576-4173

Local Attractions

Museum of Science & Industry (MOSI)
More than 450 activities await you at this non-profit facility dedicated to promoting a better understanding of science and technology.At the IMAX Dome Theatre, the world is bigger than life, filled with odd sights and sounds on a huge screen. Souvenirs ranging from totes and T-shirts to puzzles and posters are available at the Science Store. For refreshment, the MOSI Café offers pizzas, salads and sandwiches. In late February, the BARF (Bay Area Renaissance Festival) takes place here.

Salvador Dali Museum
Housing the largest collection of Salvador Dali works in the world, the museum offers a regularly changing exhibit of the legendary surrealist artist's melting-watch canvases and a wide variety of his sculpture and fiber objects that are, at the very least, intriguing. One memorable creation toasts the cocktail party; it is a vest covered with full glasses of creme de menthe. Daily tours seek to explain this complex man and his equally complex art.

Tampa Museum of Art
Established in 1979, this museum houses more than 4,500 objects in its permanent collection and exhibits the largest collection of Greek and Roman antiquities in the Southeast. The Center Gallery displays themed exhibitions from the permanent collection. For a look at 19th and 20th century sculpture set against the backdrop of the Hillsborough River, visit the Terrace Gallery. Stroll through the Outdoor Courtyard featuring contemporary sculptures, fountains and bronze work.

Craftsman House
Craftsman House is a gallery that showcases contemporary art works. It also has an on-site café serving delicious short eats and variety of beverages including beer and wines. Apart from the art works, Craftsman House also has a pottery studio that features colorful mugs, pots, vases and other wares that will adorn your living room. The innovative designs and art pieces are truly worth a look; so go ahead and visit the Craftsman House soon.

Adventure Island
Located right across the street from Busch Gardens Tampa Bay, Adventure Island’s 30 acres of water-drenched fun in the sun features the ultimate combination of high-speed thrills and tropical, tranquil surroundings for guests of all ages. Within a soothing Key West atmosphere await slides, corkscrews, water falls, a wave pool, children’s water playground and other family attractions.

Busch Gardens
At Busch Gardens, animals roam free and you are the outsider. You can see the park by monorail, cable car or train. Roller coasters, wild animals, entertaining shows, rides, food, shopping, sightseeing, bird shows, exotic flowers, train rides, Serengeti adventures, river rapids...the list goes merrily on. Wear comfy walking shoes and spend the day at this 300-acre park. You can even taste the Anheuser Busch brew that started it all. Busch Gardens is open year-round with varying schedules. Call or see Web site for details.