A regulatory strategy is a formal document that aligns the regulatory activities to bring a new or modified product to market with the business strategy for that product. It provides overall definition and direction to the project team for the product being developed by identifying the important regulatory elements to be addressed to market the device.
2. What is a regulatory plan?
A regulatory plan is a document that describes the specific steps and action required to successfully meet the regulatory strategy objectives. It contains the specific elements required to assemble the regulatory submission. Some key components might include: specific country regulatory references, a list of guidance and standards to be used, predicate devices and comparisons, a matrix of claims and the supporting data, labeling, specific pre-clinical and clinical reports, literature references and information or commitments from pre-submission meetings with regulatory agencies.
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. The team should list all that is known or will be asked about the product such as: What is the device, How is it to be used, What markets will be served, Is this a new/novel product or is it a modification of an existing device, are there similar devices being distributed and what claims will be made. Other considerations are the type of Regulatory submission, device risks, and any lifecycle considerations. Regulatory Strategies should be living documents that are reviewed and updated as the project evolves.
4. What steps should be taken to determine the regulatory submission pathway?
Fortunately, there are many resources to use when deciding the best submission route to take. FDA websites provide a wealth of data and areas such as the 510(k), PMA and MDR databases are good places to start. Also consider the FDA registration and listing database, http://clinicaltrials.gov or competitor websites to look for data on similar products. Talk with consultants and seek out guidance documents for current pathways to be considered.
5. What are some key elements of a regulatory plan?
The regulatory plan will establish specific project deliverables, timing, responsibilities and resource requirements. These should all be captured in sufficient detail to give the project team direction. Some of the essential elements will include specific testing requirements and their relationship to established standards and guidance, The predicate devices to be used, a list of product claims and the data that will support these claims, labeling, any specific facility registration or pre-inspection requirements. The plan may be developed for each individual country submission or in a format that includes all planned country submission requirements. Regardless of form, any plan should be clearly understood by all team members
Michael Santalucia has served Bausch & Lomb, Inc. as a VP Global Regulatory Affairs and has held regulatory and quality affairs positions at Valleylab and Deknatel, Inc. As a regulatory professional, he has been responsible to develop and execute regulatory strategies to bring products to market and establish company compliance programs for adverse event handling, removals and corrections and facility inspections. Santalucia is an active contributor and participant in many medical device regulatory events.