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Compliance In Focus
Posted by John Lehmann on Fri, Sep 21, 2012

Do You Need a Regulatory Strategy-- or Plan?

regulatory strategy or planAn article in MD+DI dissects the difference between a regulatory strategy and a regulatory plan by simply asking five questions to regulatory affairs expert, Michael Santalucia. We found this article to be very interesting, considering many may not have examined these differences before, which may lead to better regulatory understanding and success. The five questions, and summarized comments from the article, are listed below:

  1. What is a regulatory strategy?
    A regulatory strategy is aligns the regulatory activities to bring a new or modified product to market with the business strategy, direction and structure for the project team to bring the device to market successfully
  2. What is a regulatory plan?
    A regulatory plan describes the specific steps and action required to successfully meet the regulatory strategy objectives by including things like: regulatory elements, supporting data, labeling (etc..)
  3. What is the best way to begin developing a regulatory strategy?
    A strategy should start with the collaboration of a cross functional team to identify important questions about the product and be a living document and updated as the project evolves
  4. What steps should be taken to determine the regulatory submission pathway?
    FDA websites provide a wealth of data and areas such as the 510(k), PMA and MDR databases, or consider talking with consultants
  5. What are some key elements of a regulatory plan?
    The regulatory plan will establish specific project deliverables, timing, responsibilities and resource requirements- which if provided in sufficient detail will give direction to the project team.

Which do you think leads to overall regulatory success- a strong regulatory strategy, or a well thought out regulatory plan? Either way, regulatory success demands a team effort! Share your thoughts on this topic below.

Photo Credit: Ken whytock



Topics: Regulatory Strategy, Michael Santalucia, FDA, MD+DI


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