510(k)
Before a medical device is permitted to enter the marketplace, manufacturers must register to notify the FDA of their intent to bring a product to market. This process, often referred to as Pre-Market Notification (PMN), is regulated by Section 510(k) of the Federal Food, Drugs and Cosmetics (FD&C) Act and must be carried out at least 90 days prior to market penetration. Submission of a 510(k) affords a device manufacturer the opportunity to verify that a new product is equivalent to a device previously cleared by the FDA (post-1976). Through the PMN process, the FDA will determine if the product is “substantially equivalent” to an existing submission that has been denoted as a “cleared” Class I, II or III device. A 510(k) submission is also sometimes necessary if a manufacturer intends to modify a device that is already on the market. Depending on the nature of the 510(k) submission, the FDA is legally required to “clear” the device, address critical issues or provide a statement of rejection to the applicant within 30 or 90 days. If a 510(k) “clearance” is awarded during this process, the device can be freely marketed and sold in the United States.
Class III medical devices are usually subject to a far more stringent FDA clearance process and rarely can be brought to market by way of a 510(k) submission only. Class III devices are generally characterized by their ability to “sustain human life” and are often implanted permanently in a patient’s body. For applicants seeking to modify or bring a new Class III device to market, the FDA requires that a Pre-Market Approval (PMA) application be submitted and approved. This process takes approximately twice as long as 510(k) clearance and applicants are often forced to provide human-use data due to the high residual risk a device of this class presents in the market.
Impact
The 510(k) or PMA submission process is necessary for device manufacturers seeking FDA clearance. Applicants must prove that the chosen design, development process and use-case for their device has been successfully cleared by the FDA through a markedly comparable or “predicate” product. By demanding that device manufacturers follow this submission process, the FDA seeks to control and promote absolute patient safety.
Challenge
Filing a successful 510(k) or PMA application requires a great deal of data. The FDA requires that applicants submit detailed information pertinent to their device, including detailed product design, materials and, in some cases, clinical trial and human-use data. Convenient access to this granular data is often made difficult by the use of disparate systems for storage of design and manufacturing data. In addition, device manufacturers relying on paper-based systems for managing this important information can rarely connect important trends that may noticeably simplify and expedite their 510(k) or PMA efforts. This is especially true for Class III devices that require a much more stringent review for market clearance.
The Dyadem Solution
Dyadem provides comprehensive Quality Risk Management (QRM) solutions that enable global Medical Device companies to reduce the risk of ineffective FD&C 510(k) or PMA applications. In addition to improved access to critical product information, Dyadem also offers an integrated lifecycle model linking all parts of design, manufacturing and post-market data. Dyadem’s QRM solutions help Medical Device companies ensure they are armed with access to the right information to make FDA clearance an efficient process.
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