Navigating the 510(k) Clearance and PMA Approval Process
There are two main paths that medical device manufacturers can use to bring moderate- and high-risk devices to market with the FDA’s permission: through submittal of a premarket approval (PMA) request or 510(k) application.
Submitting a PMA application is a more extensive approach, requiring substantial evidence that provides “reasonable assurance that the device is safe and effective” through methods like clinical trials, and results in FDA “approval.” This process is reserved for high-risk Class III medical devices.
On the other hand, the 510(k) process is shorter and less costly, and results in FDA “clearance.” Applying for a 510(k) assumes a substantial equivalent, or “predicate” device, can be clearly identified. While there is no specific 510(k) form, 21 CFR 807 Subpart E details clear requirements regarding design, development, and documentation specifications for a 510(k) submission. As a result of this transparency, medical device companies can face drastic consequences if they fail to adhere to these detailed submittal requirements.
The product-centric advantage
Regardless of the approval route a device requires, the premarket submission process can be strenuous. Even the abbreviated 510(k) application requires about 25 types of documents that can result in hundreds-to-thousands of pages of text and images. Despite the grueling nature of these applications, adopting a product-centric approach throughout the new product development (NPD) period facilitates a smoother premarket notification process for medical device companies.
Linking to the product record—which includes the product’s bill of materials (BOM) and is often comprised of multiple levels of mechanical, electrical, and software components; assembly and test procedures; and other associated documents critical for classifying the device—is a pivotal feature for identifying a predicate device if needed, and for presenting correct and accurate documentation for either submittal process. Additionally, eliminating disconnects between product design, test engineering, quality, and supply chain teams streamlines the submittal process and can aid companies seeking to demonstrate substantial equivalence to a predicate device.
Missing a step at any point along the premarket application path or failing to update the application with substantial product changes not only delays a product’s time to market but, in extreme cases, can result in a company shut down due to an unmarketable product. As a result, the premarket period is a critical time for organization and communication across both product and quality teams.
How Arena QMS can help
Arena provides a product-centric QMS software solution that provides a holistic view of the entire finished device by tying quality and regulatory events to the product’s relational BOM and its revision history.
During the pre-submittal period, Arena QMS offers organizations a solution to identify and gather the pre-submittal tasks and deliverables while providing an electronic collaboration tool that will capture development and verification activity. After submission, Arena also helps teams by offering configurable templates that can be generated to address 510(k) updates and tasks that identify and track update actions. In addition, Arena QMS can be utilized to identify and capture registration and listing requirements by individual markets.
Managing premarket approvals, as well as postmarket surveillance, with Arena QMS, not only updates product records in real-time but also helps organize the application and post-submittal documentation to ensure a smooth compliance journey for the company.
Navigating 510(k) clearance or PMA approval can be riddled with obstacles and slow time-to-market to a frustrating pace. However, by adopting a product-centric approach, you can manage your premarket submittal process smoothly and with confidence.
Are you struggling to aggregate your product records, or dreading the arrival of a premarket application or postmarket study? What specific challenges do you face? Let us know how we can help you deliver high-quality products to market faster and more effectively.