ComplianceOnline

Course Description:

The FDA regulates medical devices marketed and sold in the U.S. on the basis of potential risk and according to a three category classification system.

This course on the U.S. Food and Drug Administration's 510(k) clearance and premarket approval process is intended to provide attendees with an introduction to the U.S. FDA regulation of medical devices. It will cover the FDA and its regulatory authority as it relates to medical devices. The presenter will discuss the FDA’s medical device classification system and offer suggestions for determining how a particular device will be classified and regulated. The process for going to market with a Class I, Class II and Class III device will be described with particular attention being paid to the preparation and submission of 510(k)s and PMAs.

This seminar will also provide an overview of a medical device manufacturer’s and/or distributor’s regulatory responsibilities as well as issues related to the FDA’s requirements governing medical device manufacturing, labeling and user fees. It will cover strategies for preparing and surviving the FDA on-site inspection. Finally, an overview of FDA’s medical device-focused enforcement activities and methods for mitigating enforcement risks will be discussed.



Learning Objective:

Upon completing this course on FDA regulation of medical devices, participants will:

  • Gain a basic understanding of the FDA’s structure and its laws and regulations applicable to medical devices.
  • Develop a familiarity with the FDA’s Medical Device Classification System and learn the difference between Class I, Class II and Class III medical devices.
  • Understand the difference between a 510(k) and a PMA, and when each is required.
  • Learn what is included in a 510(k), how to prepare a 510(k) and the process for selecting a predicate device.
  • Develop a basic understanding of the FDA’s Quality System Regulation (21 CFR Part 820).
  • Learn what is involved in an FDA inspection, how to prepare for an FDA inspection and strategies for undergoing a successful inspection.
  • Become familiar with the FDA’s various enforcement options as they relate to medical device marketing and sales


Who will Benefit:

This course is designed for people tasked with developing a regulatory and business strategy for the marketing and sale of medical devices in the United States. This includes individuals who are responsible for ensuring medical device compliance with the FDA’s regulatory requirements and obtaining the relevant clearance or approval needed to market and sell such products, and those tasked with the shipping and export of medical devices to the U.S. The following personnel will benefit from the course:

  • Medical Device Manufacturers
  • Senior Regulatory Professionals
  • Compliance Professionals
  • Medical Device Designers / Design Engineers
  • Corporate Legal Departments
  • Medical Device Exporters and Importers
  • Regulatory Consultants
  • Research Analysts
  • Production Supervisors
  • Quality Control Personnel
  • Medical Affairs
  • Regulatory Auditors
  • Customs Brokers
  • Medical Device Labelers
  • Convenience Kit Manufacturers
  • State Policy Officials
  • Investment Analysts
  • Venture Capitalists
  • M&A Professionals


Topic Background:

The FDA regulates medical devices marketed and sold in the U.S. on the basis of potential risk and according to a 3 category classification system. Class I medical devices are deemed to be low risk and possess the lowest regulatory threshold for entry into the market. Class II medical devices are deemed to present an intermediate risk to the user and requires the submission of a 510(k) Premarket Notification establishing substantial equivalence to a selected predicate device. Finally, Class III devices are considered novel and unique, and are deemed to pose a higher level of risk than the other device categories. Class III devices require FDA Premarket Approval prior to marketing and sale.





Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. An overview of FDA and its statutory requirements
  2. The Medical Device Regulations
    1. Breaking down FDA’s Medical Device Regulations and what they cover
  3. The Medical Device Classification System
    1. Different classes of medical devices
    2. Examples of each class
    3. General v. Specific controls
  4. Determining the regulatory status of a proposed medical device
  5. Class I Medical Devices
    1. What are they?
    2. Examples
    3. Regulatory requirements
    4. Marketing Class I in the U.S.
  6. Class II Devices and the 510(k) Premarket Notification
    1. What are they?
    2. Examples
    3. The elements of a 510(k) Premarket Notification
    4. Identifying an appropriate predicate device
    5. What device-related information is required
    6. What types of testing is required?
    7. Drafting and filing a 510(k) notification
    8. Timing Rules and the “180-day clock”
    9. Receipt of FDA questions and how to respond
    10. Obtaining 510(k) Clearance
    11. Marketing Class II Devices in the U.S.
  7. Class III Devices and Pursuing Premarket Approval
    1. What are they?
    2. Examples
    3. Introduction to the Medical Device Pre-Market Approval Program
    4. The elements of a PMAs
    5. The types of product information and testing required
    6. Drafting, Assembling and Filing a PMA
  8. The Process for bringing a medical device to market in the U.S.
  9. Individual Device Exception (“IDE”)
  10. User Fees and the Small Business Waiver Program

  1. An Introduction to the Quality System Regulation (21 CFR Part 820)
    1. What is the QSR?
    2. The purpose of the QSR
    3. Where to find it in the regulations
    4. What does it cover?
    5. Establishing a quality management system
    6. Global Harmonization
  2. A Manufacturer’s Other Responsibilities
    1. Registration
    2. Listing
    3. Adverse Event Reporting
  3. Contract Manufacturing
    1. Definition
    2. Registration Rule
  4. Labeling and Promotion
    1. The rules governing marketing and promotion
    2. The use of published literature and scientific studies in marketing materials
    3. Off-label promotion
    4. Examples of non-compliant promotion
    5. Strategies for avoiding FDA enforcement action
  5. Facility Inspections
    1. FDA’s inspectional authority
    2. Notice of inspection
    3. How to prepare for a facility inspection
    4. Conducting a mock audit
    5. The FDA inspector
    6. The day of the inspection
    7. Examples of inspections gone wrong
  6. The Status of the Medical Device Excise Tax
    1. What is it?
    2. What is the status of the tax?
  7. Overview of FDA’s Current Regulation of Mobile Medical Devices and Medical Apps
    1. What is a mobile medical device?
    2. What is a medical app?
    3. Examples
    4. How is FDA regulating them?
    5. FDA’s 2013 final guidance documents
  8. Exporting Medical Device Samples to the U.S. for Trade Shows
    1. What is required to comply with FDA rules
  9. Import for Export Rules
  10. General Export Issues
    1. FDA’s requirements for export
    2. What product information is required?
    3. The U.S. Port System
    4. FDA Port Inspectors
    5. Introduction to Customs and Border Patrol and their role
    6. Product labeling and sampling
    7. Product “holds”, “detentions” and “quarantine”
    8. Import alerts
    9. Securing removal from an import alert
  11. Case Studies: Exercises Designed To Put the Course Material to Practice





Meet Your Instructor

Karl M. Nobert
Food and Drug Regulatory Attorney, The Nobert Group LLC

Karl M. Nobert is a food and drug regulatory attorney with the Nobert Group LLC. Mr. Nobert provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration’s review and approval of new drug products. This includes counseling clients on FDA’s regulation of prescription branded and generic drugs, and over-the-counter drug products. He also has considerable experience related to the regulation of biologics including cellular and genetic therapies, and veterinary drug products. He frequently presents and has published on such topics.





Register Now

Online using Credit card


Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at customercare@complianceonline.com

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us to get details of wire transfer option.

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 @ +1-888-717-2436 or email us @ editor@complianceonline.com

Payment:
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 ComplianceOnline 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 ComplianceOnline cancels the seminar, ComplianceOnline 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 ComplianceOnline 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 ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.

Media Partners

Sponsors



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.







Local Attractions

Since 1973, Singapore Zoo has been known for having among the most beautiful wildlife park settings in the world, where animals roam freely in open and naturalistic habitats. The Singapore Zoo spans 28 hectares within Singapore's heavily forested central catchment area. The zoo, which attracts about 1.6 million visitors per year, boasts 315 animal species, some of 16% of which are considered threatened species.




The Night Safari is the world's first nocturnal zoo and is one of the most popular tourist attractions in Singapore. Today, the award-winning park welcomes more than 1.1 million visitors a year. They come from all over the world to enjoy the unique experience of seeing over 2,500 animals in their naturalistic nighttime habitats.




Universal Studios Singapore is the first and only theme park in Southeast Asia. Go beyond the screen and Ride The Movies™ at Universal Studios Singapore. Only here can you experience cutting-edge rides, shows, and attractions based on your favorite blockbuster films and television series, including TRANSFORMERS The Ride: The Ultimate 3D Battle, Shrek 4-D Adventure, Madagascar: A Crate Adventure, Jurassic Park Rapids Adventure, and more!




The Singapore Flyer is a giant Ferris wheel in Singapore that was constructed between 2005 and 2008. Described by its operators as an observation wheel, it reaches 42 storeys high, with a total height of 165 m (541 ft), making it the world's tallest Ferris wheel, 5 m (16 ft) taller than the Star of Nanchang and 30 m (98 ft) taller than the London Eye.




Underwater World, Singapore is Asia's largest tropical oceanarium and one of Singapore's most popular tourist attractions. Opened in 1991, it has more than 2,500 marine animals of 250 species from different regions of the world. It is also involved in several environmental and educational projects, such as the Living in the Ocean Programme, Ocean Ambassador Programme and the Coral Club.




Boat Quay is a zone offering an eclectic mix of high end restaurants and alfresco dining and lively bars and pubs. Boat Quay is arguably the favorite place to “chill out” for most professionals and expatriates. Lot of options available for drinks, dining from across the world. Most popular are the dining bars along the river. After a nice dinner one can head to one of the many pubs and discs around.




Sentosa is a popular island resort in Singapore, visited by some five million people a year. Attractions include a 2 km (1.2 mi) long sheltered beach, Fort Siloso, two golf courses, two five-star hotels, and the Resorts World Sentosa, featuring the theme park Universal Studios Singapore.






We need below information to serve you better

Best Sellers
You Recently Viewed
    Loading