Events

Medical Device Submissions Workshops

510(k) and De Novo Submissions Workshop: February 8-10, 2022
IDE Submissions Workshop: February 15-16, 2022
PMA Submissions Workshop: March 1-3, 2022

Upcoming Events

Access FDA and industry experts while saving on travel costs and enjoying our interactive, livestreamed workshops from the comfort of your home or office!

Medical Device Submissions Workshops

510(k) and De Novo Submissions Workshop: February 8-10, 2022
IDE Submissions Workshop: February 15-16, 2022
PMA Submissions Workshop: March 1-3, 2022

Upcoming Events

  1. Overview
  2. Pricing
  3. Speakers
  4. Agendas

Medical Device Submissions Workshops

510(k) and De Novo Submissions Workshop: February 8-10, 2022
IDE Submissions Workshop: February 15-16, 2022
PMA Submissions Workshop: March 1-3, 2022

Upcoming Events

Join us in Spring 2022 for our online Medical Device Submissions Workshops, including: 510(k), De Novo, IDE and PMA Submissions. This is the ideal introductory program for professionals who are new to regulatory affairs and want an incredible opportunity to learn more about regulatory requirements for bringing products to market.

We listened to your feedback and added a dedicated De Novo portion to the 510(k) Submissions Workshop! We also added a new feature this year to encourage collaboration with peers and connect with speakers: Applied Learning Breakout Discussions. These speaker-led, 75-minute sessions will allow attendees to apply the knowledge they gained and ask any final questions.  

This will be the only set of Submissions Workshops we offer in 2022. Don’t miss out on this unique opportunity to access FDA and industry experts while saving on travel costs and enjoying our interactive, livestreamed workshops from the comfort of your home or office. AdvaMed members can also take advantage of the group discount.

Who should attend?

  • Medical device professionals new to the FDA regulatory submission process
  • Regulatory Affairs Professionals
  • Regulatory Compliance Professionals
  • Quality Assurance Professionals
  • Regulatory Affairs Rotational Associates

510(k) and De Novo Submissions Workshop
February 8-9, 2022
Applied Learning Breakout Discussion: February 10, 2022

Gain strategies for assembling and streamlining effective 510(k) and De Novo submissions from FDA and industry experts. Attendees will also obtain insight into FDA’s perspective on the submission review process.

This workshop will cover:

  • Law and regulations guiding the use of 510(k) and De Novo submissions
  • Factors to consider when planning and assembling a submission
  • Tips and hints for interacting with FDA during the review process
  • FDA’s process for reviewing 510(k) and De Novo submissions
  • Considerations after 510(k) clearance is obtained or De Novo classification is granted
  • And more!


IDE Submissions Workshop
February 15, 2022
Applied Learning Breakout Discussion: February 16, 2022

FDA and industry experts will share the guidelines governing when an Investigational Device Exemption (IDE) is required. Course instructors will review the purpose of an IDE, share tips for making the best use of pre-submission meetings, break down the components of an IDE submission and more.

This workshop will cover:

  • The purpose of an IDE
  • Tips on making the best use of pre-submission meetings
  • Components of a successful IDE submission
  • Common errors and deficiencies in an IDE application
  • Developing an IDE strategy
  • Optimizing the pre-submission meeting
  • The ins and outs of BIMO inspections
  • And more!

PMA Submissions Workshop
March 1-2, 2022
Applied Learning Breakout Discussion: March 3, 2022

This workshop will walk you through the practical steps of filing a PMA and offer you actionable insights on how to best navigate the PMA submission process. Steps required, best practices and preparation for inspection will be covered throughout this two-day workshop.

This workshop will cover:

  • Steps to develop a PMA submission strategy
  • PMA Quality System best practices
  • What to expect during a submission review
  • Preparation needed for an advisory panel meeting
  • Tips to prepare for an inspection
  • How to deal with unexpected clinical outcomes, animal test results and adverse panel recommendations
  • Management of approved PMAs
  • And more!

“It was incredibly beneficial as a recent graduate to have had the opportunity to sit down with highly experienced professionals in the medical device field and focus on the topic of 510(k) submissions.  I’m now able to come back to my company with significant knowledge I didn’t have before and get a jump start in applying it.”

-Rotational Associate, Regulatory Affairs, Integra LifeSciences

Registration Pricing

Register before January 14 to save $100 off registration with our early bird pricing. Click here to check if your company is an AdvaMed member.

510(k) and De Novo Submissions Workshop
  • AdvaMed Member Companies: $1195.00
  • AdvaMed Accel Member Companies : $550.00
  • Government /Nonprofit: $550.00
  • Non-Members: $1595.00
IDE Submissions Workshop
  • AdvaMed Member Companies: $595.00
  • AdvaMed Accel Member Companies : $450.00
  • Government /Nonprofit: $450.00
  • Non-Members: $850.00
PMA Submissions Workshop
  • AdvaMed Member Companies: $1195.00
  • AdvaMed Accel Member Companies : $550.00
  • Government /Nonprofit: $550.00
  • Non-Members: $1595.00



Group Discount

AdvaMed members with 3 or more registrants can save an additional 10% off the AdvaMed member rate by using the code GROUP10.

*Discounts must be applied at time of registration

“The AdvaMed Submissions Workshops were very informative and helpful. In particular, hearing from experts in the regulatory field and representatives from the FDA was a great plus. It is one thing to just read the regulations, but it is extremely beneficial to have first-hand guidance from the experts.”

-Regulatory Affairs Manager, Terumo Aortic

Workshop Speakers

510(k) and De Novo Submissions Workshop
  • Tony Blank, AtriCure
  • Angela DeMarco, FDA
  • Holly Drake, Dexcom
  • Wil Henderson, Hogan Lovells
  • Quynh Hoang, King & Spalding
  • Sally Maher, Sally Maher Consulting
  • Michelle Monroe, Dexcom
  • Ken Skodacek, FDA
  • Peter Yang, FDA
IDE Submissions Workshop
  • Tony Blank, AtriCure
  • Jaap Laufer, Emergo by UL
  • Albert Rodriguez, FDA
  • Jayna Wiebel, FDA
  • Kristin Zielinski Duggan, Hogan Lovells
PMA Submissions Workshop
  • Jhumur Banik, FDA
  • Tony Blank, AtriCure
  • Jennifer Bolton, Boston Scientific
  • Kenneth Chen, FDA
  • Quynh Hoang, King & Spalding
  • Dharmesh Patel, FDA
  • Gerry Prud’homme, Hogan Lovells
  • Ken Skodacek, FDA

510(k) and De Novo Submissions Workshop

February 8, 2022

11:00 am – 11:05 am

Welcome and Introductions

11:05 am – 11:50 am

The Law and Regulations
Sally Maher, Sally Maher Consulting

  • 510(k) definition
  • 510 and 513 FDCA
  • Guidance for 510(k): general & product specific
  • How to find it
  • How to use it
  • Different types of 510(k)s; which to use
  • Review of bundling 510(k)s
  • FDA Product Codes – activity

11:50 am – 12:35 pm

510(k) Strategy and Planning
Sally Maher, Sally Maher Consulting

  • Staff involved
  • Role of each function
  • RA responsibilities
  • Use of guidance
  • Global considerations
  • Pre-submissions
  • Predicates
  • Breakthrough Devices Program
  • Safer Technologies Program

12:35 pm – 12:50 pm

Group Q&A

12:50 pm – 1:05 pm

Break

1:05 pm – 2:20 pm

Preparing the Submission
Wil Henderson, Hogan Lovells

  • General information including how to select a predicate device
  • Assembling the 510(k)
  • eCopy

2:20 pm – 2:35 pm

Break

2:35 pm – 3:50 pm

The FDA Review Process
Angela DeMarco, FDA

  • How it works at FDA
  • FDA/industry interactions
  • Refuse to Accept
  • Submission Issue meetings
  • FDA holds
  • Interactive review
  • Least Burdensome flag
  • Current pilots

3:50 pm – 4:20 pm

CDRH Ombudsman’s Office
Ken Skodacek, FDA

  • Roles & Responsibilities
  • Appeals Process

4:20 pm – 4:35 pm

Group Q&A

February 9, 2022

11:00 am 11:01 am

Welcome

11:01 am 12:20 pm

Clearance: Launch and After
Tony Blank, AtriCure

  • What clearance does and does not mean
  • Promotional practices for 510(k) devices
  • FDA
  • FTC
  • Complaint Handling and MDRs
  • When to File a New 510(k) for Device Modifications
  • Catch-up 510(k)s

12:20 pm – 12:30 pm

Group Q&A

12:30 pm – 12:45 pm

Break

12:45 pm – 1:15 pm

De Novo
Quynh Hoang, King & Spalding

  • Definition of a De Novo
  • Final Rule on De Novo
  • When De Novo is used
  • Differentiation from 510(k)

1:15 pm – 1:45 pm

Regulatory Strategy for De Novo
Holly Drake, Dexcom
Michelle Monroe, Dexcom

  • Key eligibility criteria
  • Benefit-risk analysis

1:45 pm – 2:15 pm

Preparing the De Novo Submission
Holly Drake, Dexcom
Michelle Monroe, Dexcom

  • Content
  • Assembling the submission

2:15 pm – 2:30 pm

Group Q&A

2:45 pm – 3:15 pm

Break

2:30 pm – 2:45 pm

Group Q&A

2:45 pm – 3:15 pm

FDA Review Process for De Novo
Peter Yang, FDA

  • Use of Pre-Submission meeting
  • User Fee

3:15 pm – 3:45 pm

Maintenance of a Granted De Novo
Peter Yang, FDA

  • Post-market requirements
  • Classification Order
  • De Novo database, granting order, decision summary
  • Use as a predicate

3:45 pm – 4:00 pm

Group Q&A

4:00 pm

Closing Remarks and Adjourn

February 10, 2022

12:00 pm – 1:15 pm

Applied Learning and Discussion

  • Hypothetical Case Study Review
  • Facilitated Breakout Group Deep Dive
  • Key Takeaways
  • Final Program Q&A



IDE Submissions Workshop

February 15, 2022

11:00 am – 11:05 am

Welcome and Introductions

11:05 am – 11:40 am

What Is an IDE?
Jayna Wiebel, FDA

  • The purpose of an IDE exemption
  • What an IDE does (and does not) permit
  • When manufacturers or physicians should seek an IDE
  • Roles of IRBs, investigators, and sponsors

11:40 am – 12:15 pm

Developing an IDE Strategy
Tony Blank, AtriCure

  • What to consider and when
  • Preclinical testing before human studies
  • Making the best use of pre-submission meetings
  • Using foreign data in a US submission
  • Characteristics of a successful IDE submission

12:15 pm – 12:20 pm

Break

12:20 pm – 1:25 pm

Preparing the Technical & Functional Aspects of an IDE
Kristin Zielinski Duggan, Hogan Lovells

  • Elements of an IDE: Intro/Background, Manufacturing/Device, Labeling, Reference/Other
  • Avoiding common errors and deficiencies
  • The role of risk analysis in an IDE
  • Managing planned or unplanned device or study changes

1:25 pm – 1:40 pm

Group Q&A

1:40 pm – 1:55 pm

Break

1:55 pm – 2:30 pm

Regulatory Compliance During Study Conduct
Jaap Laufer, Emergo by UL

  • Monitoring
  • Consenting of patients
  • Enrollment requirements
  • Adverse event reporting
  • Sponsor records and reports
  • Investigator records and reports
  • Protocol deviations

2:30 pm – 3:05 pm

Reporting Results
Kristin Zielinski Duggan, Hogan Lovells

  • Clinical study reports (interim and final)
  • Dissemination to the medical community and to regulators
  • Incorporation into pre-market submissions
  • Assessment of impact to product labeling
  • Requirements for registering trials on CT.gov

3:05 pm – 3:40 pm

Optimizing the Pre-Submission Meeting
Tony Blank, AtriCure

  • Purpose and value of the meeting
  • Requesting a Pre-sub meeting
  • Identifying discussion questions
  • Team preparation and rehearsals

3:40 pm – 3:55 pm

Group Q&A

3:55 pm – 4:10 pm

Break

4:10 pm – 4:40 pm

BIMO Inspections
Albert Rodriguez, FDA

  • The purpose of a BIMO inspection
  • When and how a BIMO inspection occurs
  • Preventing findings and responding to findings
  • Typical and atypical observations – cautionary tales from the field

4:40 pm

Closing Remarks and Adjourn

February 16, 2022

12:00 pm – 1:15 pm

Applied Learning and Discussion

  • Hypothetical Case Study Review
  • Facilitated Breakout Group Deep Dive
  • Key Takeaways
  • Final Program Q&A





PMA Submissions Workshop

March 1, 2022

11:00 am – 11:05 am

Welcome and Introductions

11:05 am – 12:00 pm

Beginning at the Beginning
Quynh Hoang, King & Spalding

  • When is a De Novo or PMA required
  • PMA: what to expect
    • What are the standards of evidence
    • What are the standards of review
    • Will submission go to panel
    • How much will it cost
    • How long will it take to get approval

12:00 pm – 12:45 pm

Development of a PMA Submission Strategy
Dharmesh Patel, FDA

  • Product definition
  • Development of testing requirements and strategy
  • Desired patient population
  • Desired claims
  • Early interactions with FDA
  • Planning for product iterations

12:45 pm – 1:00 pm

Group Q&A

1:00 pm – 1:15 pm

Break

1:15 pm – 1:55 pm

Mechanics of PMA Quality System Submission Development and Review
Jhumur Banik, FDA

  • Defining data requirements
  • Required elements
  • Presentation of information with clarity
  • Expectations during review
  • Best practices
  • Manufacturing & Quality Systems
  • Case for Quality

1:55 pm – 2:40 pm

During Submission Review
Jennifer Bolton, Boston Scientific

  • Interactions with the FDA
  • When/How to expect questions
  • Types of letters
  • Timelines
  • Day 100 meetings
  • Labeling review

2:40 pm – 2:55 pm

Group Q&A

2:55 pm – 3:10 pm

Break

3:10 pm – 3:55 pm

Conditions of Approval Studies
Jennifer Bolton, Boston Scientific

  • Criteria and objectives
  • Early collaboration with FDA
  • Reaching agreement
  • Reporting outcomes
  • 522 Studies

3:55 pm – 4:40 pm

Preparation for Advisory Panels
Gerry Prud’homme, Hogan Lovells

  • When?
  • Who are the panel members?
  • Why have a panel meeting?
  • Preparation for a panel meeting
  • What to expect before, during, and after
  • Best practices

4:40 pm – 4:55 pm

Group Q&A

March 2, 2022

11:00 am – 11:45 am

Inspection Activity
Kenneth Chen, FDA

  • Pre-approval inspections
  • How to prepare for an inspection

11:45 am – 12:45 pm

Dealing with the Unexpected
Tony Blank, AtriCure

  • Clinical outcomes
  • Animal test results
  • Adverse panel recommendation

12:45 pm – 1:00 pm

Group Q&A

1:00 pm – 1:15 pm

Break

1:15 pm – 2:00 pm

The Care and Feeding of Approved PMAs
Gerry Prud’homme, Hogan Lovell

  • Periodic (“Annual”) Reports
  • Supplemental Submissions
  • 30-day notices

2:00 pm – 2:30 pm

CDRH Ombudsman’s Office
Ken Skodacek, FDA

  • Roles & Responsibilities
  • The Appeals Process

2:30 pm – 2:45 pm

Group Q&A

2:45 pm

Closing Remarks and Adjourn

March 3, 2022

12:00 pm – 1:15 pm

Applied Learning and Discussion

  • Hypothetical Case Study Review
  • Facilitated Breakout Group Deep Dive
  • Key Takeaways
  • Final Program Q&A

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