How to Get Class ll Medical Device 510k Approval from the FDA

The 510k approval process for Class ll medical devices requires a lengthy preparation process to ensure that a product gets to market successfully. To pass through this approval process one must provide a convincing and detailed application that includes proper format and content, predicated devices, and guidance documents. This documents will act as an overview of how to begin the regulatory 510k approval process for a class ll medical device.

Section 510k of the Food, Drug and Cosmetic Act “requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance.” In this review process, the FDA will determine whether this product (1) equivalent to a device that already exist, and (2) is the device meets all health and safety regulations. If at the end of this 90-day process the FDA will divulge where or no the product has been approved to go to market. In many cases, during that 90-day period a device will receive a temporary Investigational Device Exemption (IDE). During this period, the device will be permitted to be used in clinical studies and test trials in order to acquire adequate “safety and effectiveness” data to accompany their 510k approval application. The main requirement that overarches the entire 510k approval process is that a product must be equal in safety and effectiveness to a lawfully marketed product OR must promptly meet an existing FDA standard.

In a limited amount of cases, products will have access to guidance documents which detail the FDA’s perspective or ruling on a specific regulatory issue. A guidance document will typically be focused on one of the following aspects of a product: the design, production, labeling, promotion, manufacturing, and testing. If a guidance document pertains specifically to one’s developed product, it is important that that person is aware exactly of the FDA’s interpretation and how it may effect the product’s development, growth or marketability. The FDA provides a database of their guidance documents and they can be accessed at anytime by clicking this link: In many cases guidance documents will assist developers by creating strict and clear guidelines on how the FDA will interpret a certain product, or what they expect to see in the products design, production etc. that will permit them to approve the 510k request. If a developer neglects to read and act upon a relevant guidance document, their device may be in directly conflict with the FDA’s ruling, and would lead to 510k approval being denied.

When a developer is in search for companies that meet the equivalency requirement of the FDA, the Product Code Classification Database (PCD) is a useful resource. The Product Code Classification Database contains medical device names and “associated information developed by the Center for Devices and Radiological Health.” The companies in this database have already passed the 510k approval process, and are helpful to developers in many ways. Because these companies have already been approved, developers access their information and determine how and what they did to receive the approval. In doing this, the FDA can quickly recognize patterns and consistencies amongst recently approved products, and newly applying ones. In this database, each company is fitted with a three letter code that is used as an identification tag within the system. Each code is assigned to a specific company, and identifies the generic category of a device for FDA. It is important that developers identify all devices that bare similarities to their own, as their approval process will have been similar as well. This useful database can be accessed by clicking this link:

When attempting to attain 510k approval for a medical device, predicated devices are required to demonstrate substantial equivalence (SE) to a legally marketed device. A predicated device is a device that is not subject to the Premarket Approval (PMA), and has already been approved for Class ll medical device 510k. These devices demonstrate to the FDA that the device one is developing is safe and effective. A predicated device can be similar to a product in many different way including the design, production, labeling, promotion, manufacturing, and testing. A substantially equivalent device will usually possess some combination of the aforementioned attributes. The FDA excepts a device to be presented with at least one predicated device to ensure that there is no potential for this new product to present any harm to its users.

Typically, a device that has recently cleared under 510(k) is usually used as a predicate device. In these cases, a recently approved device will demonstrate similar technology with comparable approval processes. Although recently cleared products are most common, “any legally U.S. marketed device may be used as a predicate.” This list includes devices that became legally marketable prior to May 28th, 1976, a device that way originally legally marketed as a class lll device, and medical devices that are exempt from the 510k approval process.

In many cases it can be difficult to identify a predicate, as technology continues to advance and transform a device’s capabilities, making it difficult to compare with past devices. The FDA does, however, recognize that there is a constant need for technological advancement, and with that comes a continuously more diverse pool of devices being developed. This 510k Premarket Predicated Device Database will act as a search engine for finding a predicated device: Product Codes, mentioned earlier, are helpful in locating companies in the database, and will quickly lead to the right substantially equivalent device. A developer may also look to its manufacturer to narrow down a list of product that share qualities their own device.

When preparing a 510k approval application, it is important to have not only the correct documents and information, but also proper formatting. This guidance document provided by the CDRH is a traditional 510k formatting, and will ensure that the FDA will have no issues finding necessary information in the application. This guidance document will also act as a checklist to ensure that all applications are correct.

In attaining 510k approval for a class ll medical device, there is a need to stress the importance of equivalence. For medical devices, the necessity of locating substantial equivalence does not require one’s product to be an identical match of a predicated device; rather the product must be “close enough that the FDA can establish that it will be as safe as the legally marketed product.” This may run against a traditional entrepreneurial mindset, but ensures that a product will go to market with the least amount of friction and delay.