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Five Steps to Regulatory Strategy Development

3. “Triangulate” and Document

Critically analyze your product and “triangulate” the various precedents researched above in determining what issues are likely to be raised for your product and how your strategy can best address them. Consider what has been done before, what has worked for other companies and, just as importantly, what prior strategies have not been successful. Document key risks or barriers and any critical assumptions, issues or questions that must be confirmed or resolved, and anticipate how prior or current requirements might evolve over the product development timeline. Determine whether your strategy should incorporate both short-term and longer term objectives, and whether any short-term wins are needed to pave the way for achievement of long-term goals.
Some specific recommendations for key regulatory pathway issues to define and document:

  • When there are different viable options for the regulatory pathway, identify the advantages and disadvantages of each for your company. The fastest route to market is not necessarily the best. For example, a PMA might offer longer-term advantages of market exclusivity, claims or reimbursement despite the lengthier approval time compared to a 510(k), particularly if the 510(k) pathway is not an obvious fit for your product and may take a long time.
  • For a 510(k) device, a comprehensive comparison between the proposed device and the predicate device(s) should help reveal likely regulatory issues and identify differences that will impact your strategy.
  • Document anticipated preclinical testing requirements, including bench, animal, biocompatibility and software testing, especially study durations for longer term studies.
  • Identify whether clinical data may be required, including follow-up duration that may be needed both prior to and following submission of a marketing application.
  • Consider how any available existing data may be leveraged.
  • Understand the likely concerns of the regulatory authority representatives who will be involved in the review of your product, and where possible, how to address these concerns proactively.
  • Propose timelines for preparing for, requesting and conducting meetings with regulators to ensure obtain agreement with planned preclinical or clinical testing and your regulatory strategy as a whole.

4. Verify the Strategy’s Viability

Once the strategy has been drafted and all key assumptions and risks are documented, seek the input of the internal stakeholder team to be sure that the strategy reflects the product attributes and project goals initially identified. Some changes should be expected as the ramifications of initial decisions about the product or project goals become apparent. For example, product claims, indications or design features may sometimes be scaled back or delayed for a future product iteration in exchange for expectations of a faster path to market.

It is often prudent to seek regulatory authority input on the key components of your regulatory strategy (such as regulatory pathway and/or planned preclinical or clinical studies), typically in the form of a pre-submission. While this may not be necessary for routine projects in which the regulatory pathway or test requirements are fairly clear, for novel products or where significant investment in new studies may be necessary, Agency feedback on a pre-submission can give you much more confidence that your proposed strategy is likely to be effective, or provide insight into areas where the strategy should be revised.

5. Make the Strategy a Living Process

Since the regulatory environment is continually evolving, it is important to stay current with regulatory developments that may impact your product or project. The regulatory climate may change as new guidance documents are developed, as similar products are approved or cleared that set a new bar for Agency expectations or in response to clinical findings reported in the literature. Keep in mind that there are also internal drivers for change, such as changes to product design or features, or changes to desired claims in response to competitor activities. Consider your regulatory strategy a “living process” so that it stays current as internal or external drivers change.


Well-reasoned and well-executed regulatory strategy can lead to a more predictable product development and clearance process. Good regulatory strategy is based upon a solid understanding of your product and its use, which drives the regulatory review process and data requirements. Know the regulatory requirements and applicable guidance documents as well as their underlying intents. Identify options and tradeoffs, and be willing to take a different approach when appropriate. Understand your company’s tolerance for risk, and adapt your strategy to business goals. Finally, continually monitor the regulatory environment and internal drivers for change, and adapt your strategy when needed so that it remains viable, achievable and likely to address company goals.

Mark D. Kramer, RAC is a regulatory consultant with over 25 years of experience in medical device regulation. He spent 17 years at the US Food and Drug Administration, most recently as the Director of FDA’s Office of Combination Products. He can be reached by This email address is being protected from spambots. You need JavaScript enabled to view it..

Regulatory Strategies



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