Course Description:

This interactive one and a half day seminar will cover the basics and advanced knowledge of the 510(k) program. It will provide insights on what FDA looks for in 510(k) submissions and common mistakes companies make in drafting 510(k)s. The course will include observations and commentary on CDRH’s new proposals for the 510(k) program such as:

  • Draft Guidance for Industry and Food and Drug Administration Staff.
  • The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].
  • The general/specific intended use guidance document and the FDA’s approach to interpreting it using real examples.

This seminar will also address the positives and negatives of pre-IDE meetings and how to approach them. Finally, it will address how to appeal adverse 510(k) decisions, whether it is an NSE decision or an Additional Information letter.

Key goals of this course are:

  • Understand how the 510(k) program is changing
  • Understand how to respond to changes in order to obtain a 510(k)
  • 510(k) strategies
  • AI Letters and Appeals – responses and strategies

Learning Objectives:

  • The FDA’s new narrow view of “general versus specific intended use,” under which the FDA now considers almost every new indication for a 510(k) device to be a new intended use such that the agency can then conclude the applicant has no legally marketed predicate device to which it can claim Substantial Equivalence and must file an onerous PMA for;
  • Permission structure for FDA review staff to inappropriately consider clinical utility/benefit and, in the case of in vitro diagnostics, clinical truth and operational truth, as part of the Substantial Equivalence criteria, which is inconsistent with the statute and the ReGen opinion;
  • Allowing FDA review staff to inappropriately consider statutes and regulatory matters extraneous to the Substantial Equivalance decision (e.g., cGMP/Quality Systems, MDR, FD&C Act advertising and promotion, and OSHA regulations or CDC guidance);
  • Inappropriately applying risk mitigation and “assurance case” principles to the criteria for 510(k) clearance;
  • More restrictively interpreting when a device has a new technological characteristic and when those technological characteristics raise new questions of safety and effectiveness.
  • Responding to AI letters and appealing NSE decisions.

Who will Benefit:

  • Executive Management
  • Risk Management Personnel
  • Regulatory and Compliance Personnel
  • Legal Personnel
  • Professionals involved with premarket notification to the FDA
  • R&D personnel involved in approving the design of medical devices
  • Sales personnel involved in approving the marketing of medical devices

Topic Background:

99% of all new devices must gain clearance through the Food and Drug Administration’s 510(k) program. Knowing how to get your 510(k) application through the FDA quickly can save millions of dollars in unnecessary investment burn. The FDA has put into practice definitional interpretations and guidance documents since the 2009 RenGen scandal in reviewing 510(k)s, which have dramatically changed the manner in which the 510(k) program operates. Some of the changes the industry is struggling with are:

  • Indications and Intended Uses: The FDA’s new view of intended use and indications for use is leading to more NSE decisions and fewer 510(k) approvals. The approach leaves nearly every new indication as a new intended use with no legally marketed predicate. Understanding the new policy can help build 510(k) strategies that avoid the onerous PMA process. This includes a restrictive interpretation of when a device has a new technological characteristic that raises new questions of safety and effectiveness;
  • Abuse of Reviewer Authority: Reviewers are considering and requesting a wider and wider scope of material before approving a 510(k). The materials often are inappropriate, such as clinical utility/benefit and, in the case of in vitro diagnostics, clinical truth and operational truth, neither of which have any role as Substantial Equivalence criteria. Knowing when to challenge information requests can help save time and money;
  • Substantial Equivalence Standard: Reviewers often mistakenly interpret the SE standard, which asks simply to look at the safety and effectiveness of the predicate device. Instead reviewers are considering statutes and matters outside the Substantial Equivalence standard, such as cGMP/Quality Systems, MDR, FD&C Act advertising and promotion, and OSHA regulations or CDC guidance;
  • Risk Mitigation: Reviewers are also inappropriately applying risk mitigation and “assurance case” principles, which ordinarily apply to PMA applications, for 510(k) clearance.

Course Outline:

Day One (8:30 AM - 4:45 PM) Day Two (8:30 AM - 1:00 PM)

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

Session Start Time: 9:00 AM

Welcome and Introductions (30 Minutes)
  1. Understanding the Basics (1 Hour)
    1. A Brief History
      1. Why is the 510(k) Program Changing
      2. The Pace of Changes and Recent Developments
      3. Overview of New Guidance Documents

    Break (30 Minutes)
  2. 510(k) vs PMA (1 Hour)
    1. How the Lines are Blurring
      1. Standard of Review
      2. Evidence Requirements
    2. 510(k) Program
      1. Elements of Substantial Equivalence (SE)
      2. Substantial Equivalence Flowchart
      3. Fundamental Data Requirements
      4. The Role of Least Burdensome (LB) Provision
      5. How LB Applies to 510(k) Submissions
    3. PMA
      1. Risk vs Benefit
      2. Clinical Data

    Break (1 Hour)
  3. Where is the 510(k) Program Today (2 Hours)
    1. Predicate Creep
      1. Reviewer’s Abuse of Discretion
      2. Multiple and Split Predicates
      3. FDA’s Repository of Knowledge
    2. Use of Old Predicates
      1. Safety
      2. Can the FDA “decommission” a predicate?
    3. New Intended Use
      1. Indications vs Intended Use
      2. Elimination of Favorable Guidance
      3. New Policy = More New 510(k)s
    4. New Technological Characteristics
      1. When is a technological characteristic different?
      2. When is there a new question of safety and effectiveness?
    5. Due Process
      1. Extraneous issues raised during review
      2. Departure from long-standing policies
      3. Rationale for Agency Decisions
    6. Stage-Gated Reviews
      1. Legal/Regulatory decisions on SE
      2. NSE decisions
      3. Use of Performance and Clinical Data

    Break (15 Minutes)
  4. Common Mistakes in Drafting 510(k)s (1 Hour 30 Minutes)
    1. Strategically Approaching the 510(k)
      1. Remembering the SE Standard
      2. Begin with the End in Mind
      3. 510(k) as an Advocacy Document
    2. Choosing Predicate(s) Intended Use Considerations
      1. More of the Same – Mirroring the Predicate
      2. Minor Differences May Mean a Change of Use
      3. Marketing Mileage through Finesse
    3. Selecting Predicate(s) Same Technological Characteristics
      1. Use of Clinical Utility/Benefit
      2. Challenging a Reviewer’s Empty Reasoning

    Welcome (15 Minutes)
  1. Bigger Growing Pains (2 Hours)
    1. What’s New in the Draft Guidance on SE
      1. Obvious Changes
      2. Subtle Changes
      3. Keeping Up
    2. FDA Safety and Improvements Act (FDASIA)
      1. Strengthening the LB Approach
      2. Necessary Clinical Data
      3. Reviewiers Summaries
      4. Expedited Appeals

    Break (15 Minutes)
  2. Other Guidance Documents (1 Hour)
    1. Review new draft guidance documents on clinical trials, evaluating de novo devices, developing and using product codes, mobile apps and others
  3. Appeals and AI Letters (1 Hour)
    1. The Challenge of Additional Information (AI) Letters
      1. Analyze the Requests
      2. Strategy to Answering
      3. In-Person Meetings
    2. Appeals
      1. AI Letters and NSE Determinations
      2. When is a Decision a Decision
      3. How to Appeal
      4. Utilizing the Ombudsman

Meet Your Instructor

Marc C. Sanchez
Founder, Attorney & Regulatory Consultant, Contract In-House Counsel & Consultants, LLC

Marc C. Sanchez represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device and drug industries. With a focus on international trade, Marc advises clients on the regulatory requirements and strategic corporate considerations that affect the importation, distribution and exportation of FDA regulated products. He is considered a leading voice in understanding FDA regulations and cross-border regulatory issues with interviews and contributions in the Washington Post and Huffington Post.

For the medical device industry, his practice includes both pre-market approval and post-market surveillance matters in the US, European Union, Mexico , Brazil and China. He began his career with the legal division at Nike’s European Headquarters. There he headed up product recalls, pricing, and digital privacy in the EU, US, China, and Japan. After Nike, he began his own practice focusing on product recalls, regulatory compliance, government contracts and cross-border trade compliance. He is the founder of Contract In-House Counsel and Consultants, LLC. His firm utilizes a cost effective model of adding a contact in-house attorney to small and mid-sized companies to provide expert counsel on a short and long-term basis. He currently serves clients across the US, EU, China, and Middle East.

He received a Masters in International Commercial Policy from Valparaiso University and earned his J.D. from Lewis and Clark College. He is a member of the Washington Bar Association and Regulatory Affairs Professional Society.

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