Drafting 510(k) Submissions Under New FDA Policies - 2012 & Beyond

Instructor: Bob Michalik, JD, RAC Michalik
Product ID: 702500
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Training CD

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Read Frequently Asked Questions

This 90-minute 510(K) training will provide practical tips and tools (templates) for preparing regulatory marketing submissions that will ensure swift clearance of your Class II and Class III medical devices.

Course "Drafting 510(k) Submissions Under New FDA Policies - 2012 & Beyond" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

FDA has initiated substantial changes to the Premarket Notification “510(k)” process that significantly increase the data and documentation requirements for Class II medical devices. Very few manufacturers are aware of the practical changes that will be needed during design control and 510(k) submission process to ensure lengthy and expensive delays do not occur for their new products.

The focus of this webinar is NOT on general theory of legal and regulatory compliance, but rather a practical ‘roll up your sleeves’ approach towards planning and implementing essential changes within your own company that will meet the FDA requirements for 510(k) cleared products. In this webinar, essential pragmatic methods and practical tools will be discussed in detail - techniques and procedures that you will be able to implement immediately to guide your teams and ensure compliance with the upcoming changes related to Class II and Class III product registration requirements.

The webinar will begin with a very brief, but comprehensive overview of the regulatory changes that have occurred over the past three years relating to the premarketing notification processes (per U.S. FD&C Act sec. 510(k)) applicable to Class II medical devices. However, the bulk of the presentation will focus on real world problems, and issues that can impede the regulatory submission review and clearance process.

Participants will be taught a number of legal writing and development data gathering skills that will be indispensable in preparing clear, persuasive and undeniable regulatory 510(k) submissions. FDA now expects enhanced data to support claims of safety and efficacy of Class II devices. Learn how to adjust your existing design control processes to streamline data generation without throwing out’ or substantially revamping your entire design control scheme.

Free Handouts:

We will review and discuss three free template documents prepared by the presenter, an FDA Regulatory Attorney, and provided to each webinar participant:

  • Corporate Policy for Compliance with FDA Changes to the Premarket Notification “FD&C Act sec. 510(k) Process”
  • SOP on How to Prepare a 510(k) Submission to Meet FDA Requirements – 2012
  • Compliance Checklist - 510(k) Submission – 2012

Areas Covered in the Seminar:

  • Overview of the FDA Regulations pertaining to the development of Class II medical devices, including.
  • Drafting 510(k) submission using new recommended practices by FDA.
  • Guiding Class II medical device development teams in design control practices that will yield effective data to evidence ‘substantial equivalence' to your selected predicate device(s).
  • Enhanced 510(k) manufacturing data requirements.
  • Learn efficient methods to generate the type of safety and effectiveness information FDA now expects, including easy to implement “clinical literature review and compilation” practices; and How to write 510(k) submissions that ensure clearance in the shortest time possible;
  • Legal writing tips designed to overcome FDA ODE reviewer comments and challenges of ‘non substantial equivalence' (NSE) to selected predicate device(s).
  • Learn when you, the Regulatory Affairs professional, should ‘push back' and challenge FDA reviewer opinions regarding compliance with 510(k) regulatory requirements;
  • Learn other legal and regulatory techniques that protect you and your employer from future enforcement actions (e.g., 483 inspection deficiencies, warning letters, coerced product recalls, etc) relating to recently cleared products.
  • Tactical tools will be presented in the framework of an overall regulatory strategy so you can effectively communicate your plan to senior management, the development team, and most importantly, to government regulators. Templates, Checklists and other proven tools will be available for all participants to incorporate immediately in their own practice.
  • Discussion of the most common flaws and pitfall in product development programs that increase the regulatory burden on a manufacturer under the new FDA 510(k) process. These include:
  • Practical and immediate steps to take to dramatically reduce the cost of regulatory compliance for Class II/III devices.
  • Long-term strategies to ensure an efficient product development program.

Who Will Benefit:

Individuals who will benefit include:

  • Management and personnel from all departments who wish to remain abreast of key changes in FDA CDRH policies
  • QA/QC/Compliance/Regulatory Affairs
  • Engineering/R&D/Technical Services
  • Marketing
  • Consultants to the medical device industry
  • Operations/Manufacturing/Validation personnel

This webinar will be particularly beneficial to those professionals in decision-making positions with responsibility for day-to-day activities and oversight of product development teams.

Instructor Profile:

Robert J Michalik, Esq, RAC, is a licensed regulatory attorney in Massachusetts and founder of, a consulting firm providing general and specialized services to the biopharmaceutical and medical device industries. Mr. Michalik has over 25 years’ experience working in the biopharmaceutical and medical device industries. Starting with a bachelor's degree in science (biochemistry), Bob has held a wide variety of technical, quality and regulatory positions that literally span the scope of new product development and commercialization activities.

In addition to his legal and regulatory practice, Mr. Michalik is also a faculty member at Northeastern University in Boston, MA where he teaches graduate-level coursework in the areas of FDA law and regulation within the Master’s Degree in Regulatory Affairs program.

Topic Background:

Due to dramatic changes in FDA 510(k) product development policies, predicting if and when FDA will clear of your Class II medical device has never been more difficult than now. Even experienced Regulatory Professionals are having trouble understanding and integrating FDA’s new 510(k) and design control policies into their day-to-day practice. Reliance on old regulatory strategies places your development team and company in jeopardy of not achieving marketing clearance and can waste hundreds of thousands of dollars in project costs. This 510(K) training will provide practical tips and tools (templates) for preparing regulatory marketing submissions that will ensure swift clearance of your Class II devices.

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