FDA 510(k) Program

What Is the FDA 510(k) Program?

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 if problems arise.

When Do Companies Have to Submit a 510(k) Form?

When a Premarket Approval application (PMA) is not required, companies that want to market a Class I, II, and III device will need to submit a 510(k) – unless the device is exempt from 510(k) requirements. Before companies are able to market their device, they’ll receive an order from the FDA. This order will state that their device is substantially equivalent and this order allows producers to begin their commercial distribution of their devices.

What Makes a Device Substantially Equivalent?

A 510(k) requires that the submitted device demonstrates substantial equivalence to another FDA-approved, legally marketed device in the U.S. This means that, by comparison to the other device, it can be predicted that the new device is safe and effective. 

According to the FDA, a device is substantially equivalent if, in comparison to a predicate, it: 

• Has the same intended use as the predicate device; and 
• Has the same technological characteristics as the predicate; 

or 

• Has the same intended use as the predicate; and
• Has different technological characteristics and does not raise different questions of safety and effectiveness; and
• The information submitted to the FDA demonstrates that the device is as safe and effective as the legally marketed device. 

It is required for any individual to submit clear evidence, tests, and other data that prove that the new device is substantially equivalent. 

What Are Exemptions to the 501(k) Requirements?

Most class I and class II devices are exempt from 510(k) requirements.

Devices that may be 510(k) exempt include: 

• Preamendment devices or devices legally marketed in the U.S. prior to May 28, 1976.
• Class I devices specifically exempted by the FDA or classified as class I under section 513
  • Examples of class I devices: manual surgical instruments, examination gloves, tongue depressors, and nonpowered orthopedic devices. 
• Class II devices with special controls
  • Examples of class II devices: powered wheelchairs, dental floss, and pregnancy test kits. 
• Class II devices with published performance standards.
  • Examples of class II devices: dental hand instruments, intraocular lenses, and in-clinic electronic thermometers. 
• Certain class II devices with Premarket Notification exemption. 

A list of class I and class II devices exempt from 510(k) requirements can be found on the FDA website. 

What Is the 510(k) Approval Process?

The approval process for a 510(k) device may seem strenuous. However, in comparison to regular device applications and FDA approvals, this process is significantly shorter. The following steps will 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 qualifies for the FDA 510(k) Approval Process.
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.
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. They 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.

What Are the Negative Effects of the 510(k) Program?

Over the years, there have been many research studies on devices and materials that were approved via the 510(k) program. Patients who have been harmed by materials such as mesh or other medical devices have expressed concerns that the materials and devices were approved by the FDA. They are worried that the 510(k) process allows unproven medical devices on the market since the clearance doesn’t necessarily require proof of safety for class I or II devices. As a result, the public is uninformed and unaware and is endangered daily by unproven and unsafe medical devices. 

What Research Has Been Done on the 510(k) Program? 

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:

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?

What Were the Results of the Research?

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 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.

What Should Change About the 510(k) Program?

Despite IOM’s claim that the 510(k) shouldn’t be fixed, there are organizations and affected patients who want to see reform in the 510(k) approval process.

They offered recommendations that could benefit the public:

• Educate the American public about the difference between premarket approval and premarket notification
• Make adverse-even reporting mandatory, with clear consequences for silence by doctors, hospitals, and medical device makers. 
• Create a specific guide for the FDA to make better use of their regulatory authority. 
• Include a mechanism that stops medical device makers from paying doctors to use products off-label to increase the sales of their products. 

In general, the main problem is the lack of transparency from the FDA, medical manufacturers, and doctors with the patients.