FDA's 2011 Revised 510(k) Premarket Notification Process: The Medical Device Professional's Guide to Successfully Preparing 510(k) Submissions & Regulatory Compliance

Instructor: Bob Michalik, JD, RAC Michalik
Product ID: 701938
  • Duration: 80 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

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Read Frequently Asked Questions

This 510(K) training will help you understand and be prepared for substantial changes to the Premarket Notification 510(k) process for Class II medical devices.

Why Should You Attend:

FDA is poised to initiate substantial changes to the Premarket Notification “510(k)” process that will 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.

As a Project’s Regulatory Leader, Quality Assurance Manager or Principal Design Engineer, what you do to craft a strategy will have profound ramifications for the company in terms of profitability, not to mention the product’s likelihood of clearing the evolving regulatory hurdles.

Do you have the knowledge, skills and tools necessary to lead your team to marketing clearance or approval? Do your current strategies address national (U.S. FDA) and international regulatory requirements (EU, Canada, etc) ensure a lean and FDA-compliant engineering, quality, clinical and regulatory practices are employed?

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 focus of this webinar is NOT on general theory of legal and regulatory compliance, but rather a practical ‘roll up your sleeves’ approach toward planning and implementing changes in your own company that will meet the upcoming FDA requirements for 510(k) cleared products.

The tactical tools will be presented in the framework of an overall regulatory strategy so you can see the “forest for the trees” and effectively communicate your plan to senior management, the development team, and most importantly, to government regulators.

Ample examples, sources for additional reference reading, and model company policies and SOP templates will be provided so that you can immediately initiate plans and actions to adjust your internal practices.

Areas Covered in the Seminar:

  • An intensive, brief but in-depth review of FDA’s current policy relating to the 25 recommendations the Agency has states it intends to implement in 2011;
  • Discussion of the FDA projected timeline for completing milestones for revamping the 510(k) review process;
  • Specific discussion of the essential tactical activities and procedures that should be adopted by manufacturers this year to streamline compliance with the new regulatory requirements and FDA policy changes;
  • 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”, and
    • SOP on How to Prepare a 510(k) Submission to Meet FDA Requirements – 2011
    • Compliance Checklist - 510(k) Submission – 2011
  • 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:
    • Enhanced 510(k) manufacturing data requirements,
    • the type of safety and effectiveness information, including easy to implement “clinical literature review and compilation” practices,
    • when to anticipate a pre-clearance inspection, and
    • when to periodically report post-marketing information to FDA in lieu of submitting another 510(k)
  • 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:

This webinar will provide valuable assistance and guidance to all medical device companies that are preparing and submitting 510(k)s to FDA for review and approval. The employees 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
  • Operations/Manufacturing/Validation

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 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 20 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 Masters Degree in Regulatory Affairs program.

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