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Five Steps to Solid Regulatory Strategy Development

By Mark D. Kramer, RAC

Regulatory strategy is a plan of action designed to achieve a specific regulatory goal, such as to obtain approval or clearance of a new orthopaedic product. Since regulatory requirements continue to evolve and become increasingly complex, solid regulatory strategy and execution can maximize the opportunity to achieve the regulatory goal and provide a competitive advantage.

A good approach to strategy development begins by involving internal stakeholders to thoughtfully identify product attributes that could have regulatory impact, then conducting regulatory intelligence on possible precedents, documenting the strategy, verifying the strategy’s viability and finally by reviewing (and if necessary, revising) the strategy as circumstances change.

1. Identify Product Attributes

The objective at this stage of strategy development is to comprehensively identify the attributes of the proposed product so that the regulatory implications of its intended use, design and performance can be thoughtfully assessed. While the regulatory affairs member of the team will often have lead responsibility for developing the regulatory strategy, the strategy is likely to more fully reflect company objectives and be successful if relevant internal stakeholders are involved in this phase of the process. The stakeholders will vary depending upon the specific product or project, but would typically minimally include regulatory, R&D/engineering, marketing and medical/clinical affairs. Other relevant functions could include quality, reimbursement, manufacturing and supply chain, as well as external stakeholders such as from partner companies, key suppliers or consultants.

Since a regulatory strategy will typically vary based upon the specific facts at hand, it is important to fully understand the proposed product. Therefore, it is helpful to begin by formulating a series of open-ended questions that will help ensure that the strategy development team is aware of and appropriately considers factors that may have regulatory impact. If the product is early in development, such an exercise may help crystallize certain aspects of the design or features that have not yet been finalized, or that influence the design in order to minimize issues with regulatory impact. Consider the following types of issues, as well as any unique issues raised by the specific product:

  • Intended use (intended users, use environment, patient population, unmet medical need)
  • Design and features (unique features/functionality, novel mechanism of action or materials)
  • Proposed claims (highest priority and nice-to-haves)
  • Similar products (data then required, how you will support differences between the products)
  • Target markets (desired or required staging of approvals)
  • Anticipated data to support claims and meet regulatory and reimbursement objectives
    (bench, animal, clinical, usability)
  • Anticipated regulator concerns (impact on clinical practice, new precedents, new or special
    patient or user population, potential for off-label use/claims)
  • Jurisdictional concerns (possible drug, biologic or combination product instead of device)
  • Postmarket concerns (adverse events and malfunctions reported for similar products)
  • Potential need for post-approval studies

2. Conduct Regulatory Intelligence

Once you have thoroughly identified product attributes with potential regulatory impact, determine what regulatory precedents are available that could impact your regulatory strategy. Keep in mind that while there may be no product that raises precisely the same issues as your proposed product, you can often find analogous products, even in medical specialty areas outside of orthopaedics, that could help inform your strategy.

For regulatory strategies to market a new product in the U.S., FDA’s website is often an excellent place to start. In recent years, FDA has increasingly asked companies to ratchet up the level of detail in 510(k) summaries that are posted upon device clearance, which helps shed more light on prior products and the studies required for their clearance. Commercial regulatory intelligence systems are also available to make searching the FDA 510(k) database more efficient. For novel devices that have gone through the de novo classification process, more detailed FDA review summaries are available. For PMA devices, even more extensive information is available on review requirements in FDA’s Summary of Safety and Effectiveness. Advisory panel meeting transcripts can provide additional insight into FDA’s thinking for particular products or issues in the medical specialty area. FDA databases on MDRs and recalls give insight into postmarket concerns that may sometimes influence FDA’s premarket requirements.

An increasingly helpful source of information is the clinicaltrials.gov website, which may help identify products in clinical investigation, inform clinical trial design strategy and provide insight into study results. Websites of competitors are sometimes also a good source for gathering information about clinical study design, potential labeling claims and other issues. Consultants can also offer valuable insight based upon their experience with similar products.

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 at kramer@regulatorystrategies.net.