FDA 510k Program

The U.S. Food and Drug Administration (FDA) has developed an assortment of approval systems over the past 50 years. The purpose of these newer approval systems is to accelerate the approval of certain medical devices. By accelerating the approval of various types of medical devices, the FDA intended to provide the American public with access to cutting-edge medical care. These accelerated-approval devices were meant to address medical concerns that either had no current treatment options, or only had very poor treatment options at the time of FDA 510(k) Approval.

Emerging research suggests that the accelerated FDA approval systems may cause the public more harm than help. Numerous defective medical devices have caused harm to patients, resulting in medical device recalls and class-action lawsuits against large manufacturing companies. Furthermore, many of the large medical device manufacturers have faced charges for bribing doctors to use their specific medical devices.

What is the FDA 510(k) Program?

The FDA offers medical device manufacturers a number of methods to fast-track their medical device approval process. However, the FDA 510(k) Program appears to be one of the preferred ways for manufacturers to quickly get a new medical device on the market. Due to flaws in the FDA 510(k) Approval System, this is jeopardizing the safety of the American public.

510(k) Premarket Notification

The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of similarities to a current medical device that is already on the market. The major flaw in the FDA 510(k) Approval Process is that the FDA cannot predict, at the time of 510(k) Approval, whether the currently-marketed medical device will end up being dangerous for long-term use. This makes it easier to get a medical device on the market, but tougher to remove that medical device from the market once problems arise.

Problems with the FDA 510(k) Program

If a medical device is approved through the FDA 510(k) Approval Program, and the product that it was compared to during the approval process is recalled, there are many problems. The newest medical device is typically dangerous as well, due to its proven similarities with the recalled product. However, the new medical device is not automatically recalled when the original device is recalled. Each medical device and brand is dealt with separately, which leaves the opportunity for a defective medical product to stay on the market for long periods of time.

FDA 510(k) Approval Process

The following steps outline how a medical device manufacturer attains approval through the FDA 510(k) Program:

1. Confirmation of the suggested medical product as an actual medical device, and classification of the type of medical device. Using the FDA Classification Database, large medical device manufacturers are able to sort through current medical device classifications. The medical device manufacturer discovers how to prove the new medical product is a medical device and that it is applicable for the FDA 510(k) Approval Process. The company is then able to classify the medical device.
2. Locate and identify predicate medical devices that are already FDA-approved and cleared for sale in the United States. By searching the online FDA 510(k) Database, medical device manufacturers quickly sort through current medical devices that are either available for sale or approved for sale in the U.S. Once an approved medical device is identified, the similarities between the current and proposed devices are established. The current medical device, that the manufacturer compares the proposed device with, is called the predicate device.
3. Determine and locate any applicable standards or guidance documents. For FDA 510(k) Approval, the medical device manufacturer uses the FDA Product Classification Code to research any special instructions, guidelines, or international standards for the new medical device. These requirements must be met in addition to the generic FDA 510(k) Approval Process steps.
4. Submission of the FDA 510(k) Approval application. The medical device manufacturer must submit safety research, performance testing, standards requirements, and proof of similarities with the predicate device to the FDA for review. Due to the fast-paced nature of the FDA 510(k) Approval Process, the safety research and performance testing are minimal when compared with standard FDA approval qualifications.
5. FDA reviews 510(k) Approval submission within 90 days. The FDA charges the medical device manufacturer an additional fee for the fast-track 510(k) Approval Process. Once the medical device is FDA-approved, a clearance letter is sent to the medical device manufacturer with a 510(k) identification number.
6. Medical device registration on the FDA website. The medical device manufacturer must register with the FDA online, if the company has not previously sold medical devices within the United States. In addition, the medical device manufacturer must register the FDA-approved medical device on the FDA website using the 510(k) identification number. The FDA charges the manufacturer an annual fee to remain clear for medical device sales within the U.S.

FDA 510(k) Clearance Process IOM Research

In 2011, the National Academies Press published a book by the Institute of Medicine (IOM) of the National Academies, which is a sector of the National Academy of Sciences (NAS). The book is titled Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years. In the book, the IOM attempts to answer two questions from the FDA concerning the 510(k) Approval Process. The IOM worked in conjunction with the Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process while authoring the book.

The two questions the FDA requested for the IOM to review, regarding the 510(k) medical device approval process, were:

1. Does the current FDA 510(k) Approval Process protect patients in an optimal manner and promote innovation to support public health?
2. If not, what are the recommended administrative, legislative, or regulatory changes to provide optimal patient protection and support public health through the FDA 510(k) Approval Process?

The IOM concluded that the current FDA 510(k) Approval Process is fundamentally flawed based on the program’s legislative foundation. Upon researching and reviewing 35 years of documented 510(k) Approvals, the IOM recommended that the FDA does not spend any more resources on attempting to fix the current 510(k) Approval Process. Instead, the IOM cited the Federal Food, Drug, and Cosmetic Act (FFDCA) which requires “a reasonable assurance of safety and effectiveness” prior to clearing a medical device for sale in the American market. The IOM stated that the FDA should invest resources in designing integrated premarket and postmarket regulations. This would help assure medical device safety and effectiveness during all stages of the device’s life cycle.