Getting authorization from the U.S. Food & Drug Administration (FDA) to launch a new medical device can be a tricky process. After the device is properly classified, you must then choose the appropriate pathway to bring your product to market. In order to legally market or sell these products in the U.S., they must have either FDA approval or clearance, or in cases of De Novo requests, authorization must be granted by the FDA.

Many individuals and businesses use the terms approval, clearance, and granted interchangeably; however, each one applies to specific regulatory submission routes used to ensure the safety and efficacy of medical device products. Understanding the distinctions between this terminology, and how to apply it appropriately, can be vital to streamlining FDA inspection processes and avoiding potential legal ramifications.

The Type of Authorization a Medical Device Receives Is Based On Its Classification

The FDA groups medical devices into three distinct classes, or categories, depending on the level of regulatory control necessary to assure the various types of devices are safe and effective.

Class I medical devices pose the least amount of risk to a person’s health and quality of life, and range from tongue depressors and blood pressure machines to thermometers, Band-Aids, and other products. The majority of medical devices fall under Class II, and carry a moderate-to-high risk for end users. Examples include pregnancy test kits, powered wheelchairs, infusion pumps, and surgical needles and suture material. Products such as pacemakers and breast implants are considered Class III medical devices, which present the highest level of risk out of all the classes. According to the FDA, these types of products “usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.”

Most Class I and some Class II medical devices are exempt from 510k submission requirements. However, medical device companies that aim to  establish that their medical devices are substantially equivalent to existing medical devices on the market, must submit 510k submissions. Medical devices in the 510k category receive a FDA clearance to appear in the marketplace.

Class III medical devices present the greatest potential risk out of all the classes. Federal law requires actual data, including scientific proof, that a product’s benefits outweigh the risks. Once this is established, along with a premarket approval (PMA), the FDA issues an approval to bring a Class III medical device to market.

Sometimes, new Class I and Class II medical devices are placed in the De Novo premarket review pathway, which is essentially a risk-based classification process used if there are no legally marketed predicate devices. With this approach, the FDA requires substantial evidence, supported by general controls and/or special controls, to demonstrate the safety and effectiveness of what are considered “novel” medical devices. If these requirements are met, then the De Novo request is granted by the FDA.

Now that we understand how each medical device class receives its green light to launch, let’s see why the FDA chooses its word wisely.

Erroneous Classification of Medical Devices Can Be Costly

Medical device companies often lament over how stringent FDA regulations can be. However, as is evidenced by the 80,000+ deaths and 1.7 million injuries in the past decade linked to faulty medical devices, there are those who believe that FDA regulations are not rigorous enough or have loopholes.

One of the most notorious medical device recalls was for a transvaginal mesh product used to treat pelvic organ prolapse (POP), a common condition among women. POP occurs when pelvic organs aren’t supported properly due to weak muscle and tissue in the pelvic floor. One way that surgeons approached treating this condition was with a transvaginal mesh implant, to help strengthen the pelvic wall. Certain recipients of this implant, however, complained of life-altering complications such as painful intercourse, incontinence, vaginal bleeding not related to menstrual cycles, and pelvic pain.

Unsurprisingly, multiple lawsuits were brought against manufacturers of transvaginal mesh, with the earliest documented trial in 2012. Most recently, in March 2021, Boston Scientific, one of the manufacturers, was ordered to pay $189 million in damages and fees.

Boston Scientific, along with certain other transvaginal mesh implant manufacturers such as Johnson & Johnson and Becton Dickinson and Company (also known as BD), received clearance from the FDA via 510(k) submissions. The hitch is, companies utilizing this regulatory process are not required to produce clinical trial reports and extensive research before bringing their products to market. A better classification for this implant might have been Class III with a premarket submission.

The 510(k) designation for the transvaginal mesh proved to be one of the costliest misnomers in the history of the FDA, which has been criticized for not doing its due diligence to ensure that the implants were safe for public use, among other complaints.

There is a valuable lesson in this scenario for all medical device development stakeholders: Proper classification is key to ensuring the appropriate regulatory requirements are met to support the safety and efficacy of new medical devices.

Following FDA Regulations and Understanding FDA Language Can Be Financially Beneficial 

Bringing a new medical device to market is a multifaceted process. It requires expert understanding—and extensive patience—from medical device companies and manufacturers alike to satisfy rigorous regulatory requirements. Medical device recalls can cost companies millions or even billions in litigation and sales losses. This is why it is crucial to comprehend FDA regulations, including the different classifications of medical devices, to save time and valuable resources.

Pathway Medtech excels at helping medical device companies navigate the regulatory pathways of the FDA. Choosing the right regulatory approach for your exact product can help you get to market quickly and seamlessly.

Contact our team to learn more!