The scope and complexity of information required by the 510(k) review process means that manufacturers seeking market clearance for new medical devices must develop a comprehensive compliance strategy to avoid unnecessary delays and setbacks in the submission and review process. At a minimum, such a strategy should include the following elements:
Develop an in-depth understanding of the 510(k) program and process—The FDA has developed one of the most comprehensive medical device regulatory programs in the world, along with an extensive catalog of guidance documents on the application of its regulations for the review and clearance of medical devices. Manufacturers who develop an in-depth understanding of the FDA’s requirements and processes as they apply to specific medical devices can avoid many of the errors or omissions illustrated earlier this paper.
Stay current—Today’s medical device industry is characterized by continuous innovation. In this dynamic environment, the FDA is continually reviewing its regulations and practices, and modifying existing requirements or developing new ones to remain current with the latest product developments. Therefore, staying abreast of the FDA’s proposed rulemakings and other actions can provide device manufacturers with advanced notice of regulatory changes that could affect their products.
Formulate a 510(k) action plan as early as possible—The most effective way to achieve 510(k) clearance with minimal surprises and setbacks is to integrate regulatory compliance planning into the new product planning process. This integrated approach saves time, since requisite testing can be coordinated with product development activities, and provides greater flexibility in addressing design changes required by regulatory considerations.
Dedicate internal resources for the duration—Because of the complexity of the regulatory review process, device manufacturers should consider appointing specific individuals within the organization with the responsibility for overseeing and addressing regulatory compliance issues for the duration of the project. Doing so will reduce the risk of gaps in vital communications and understandings that can result in delays in the device review and clearance process.
Engage a knowledgeable advisor—There is no substitute for experience. A knowledgeable advisor or consultant with extensive medical device expertise and first-hand experience dealing with 510(k) submissions can quickly determine the requirements applicable to specific medical devices, streamline the 510(k) documentation process and anticipate most, if not all, of the challenges encountered by manufacturers that choose to navigate the process alone.
Over the past decade, UL has worked with medical device manufacturers on over 700 510(k) submissions through the FDA’s Accredited Persons program. This extensive experience with the FDA medical device clearance process and a wide variety of medical devices makes UL a reliable partner for global manufacturers seeking entry into the U.S. market.