If your company is planning to bring a new medical device to market, FDA approval is one of the most important steps you can take. The U.S. Food and Drug Administration (FDA) is a regulatory body designed to ensure that all substances and procedures used by Americans in their daily life are safe. Their approval process may seem daunting, but there are ways for you to navigate it confidently and efficiently. In this post we outline some of the highlights of the process to help you know what to expect.
What is considered a medical device?
The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is the one responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. The approval process is intended to provide consumers with assurance that once a medical device reaches the marketplace it is safe and effective in its intended use.
According to the Federal Food Drug and Cosmetics Act, a device is “an instrument, apparatus, implement, machine, contrivance, implant or an in vitro reagent” that meets 3 conditions:
1) It is recognized in the official National Formulary or the U.S. Pharmacopeia;
2) It is intended for use in the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease; or
3) It is intended to affect the structure or function of the body of humans.
There are a wide range of objects that fall under the FDA definition of medical devices, from tongue depressors and stethoscopes, to lab equipment, surgical instruments, and life-support equipment such as pacemakers and ventilators. If you are in doubt about whether your product is a regulated device, check out the FDA’s post on How to determine if your product is a medical device.
To determine if your product meets the definition of a medical device, you should define the intended use and indications for use of your product. If your product is intended for general wellness use only, and is low risk, it may not be actively regulated by the FDA. For more information on how the FDA defines and regulates a general wellness product you can refer to the FDA’s guidance document General Wellness: Policy for Low Risk Devices.
How to determine classification
Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. Device classification depends on the intended use of the device and also upon indications for use. Risk is also a major factor in classification, meaning the risk the device poses to the patient and/or the user. Class I includes devices with the lowest risk and Class III includes those with the highest risk. The three classes are:
1. Class I – These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process.
2. Class II – Many medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 43% of medical devices fall under this category.
3. Class III - These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.
Exempt – If a device falls into a category of exempted Class I devices, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, the manufacturer is required to register their establishment and list their generic product with the FDA. Some examples of exempt devices are manual stethoscopes, mercury thermometers and bedpans.
In order to find the classification of a device you need to find the regulation number that is the classification regulation for your device. There are two methods for achieving this: either go directly to the classification database and search for a part of the device name, or, if you know the device panel (medical specialty) to which your device belongs to, go directly to the listing for that panel and identify your device and the corresponding regulation.
For example if your device falls under the cardiovascular specialty you would refer to part 870 of the Title 21 of the Code of Federal Regulations (CFR). Listed here you can find a wide variety of devices such as blood pressure cuffs or ECGs and the classification for each device under that specialty (these are both listed as Class II).
You can also request a formal device determination or classification from the FDA by submitting a 513(g) request.
It is also possible to request a humanitarian device exemption (HDE) for devices intended to help with rare diseases, as the sample size is often too small to obtain enough clinical evidence to meet the FDA’s reasonable assurance standards for “safety and effectiveness”. In accordance with the Orphan Drug Act (ODA) of 1984, a rare disease is defined as a disease or condition that affects fewer than 200,000 people in the United States.
What does the approval process look like?
After you’ve determined your product is considered a medical device and you’ve classified it you must determine the regulatory path for it.
The regulatory pathways for medical devices – 510(k) clearance and PMA (Pre-Market Approval) depends on the classification of your device. Most Class I medical devices can be self-enrolled, but a large number of Class II devices require a 510(k) premarket notification submission. And for Class III medical devices, a PMA submission is often required.
Depending on product type, the FDA certification process includes the following steps:
- Determine the indication for use
- Determine the proper 7-digit regulation number and classification type
- Find a predicate device and create a comparison chart
- Carry out required performance tests
- Fill out an FDA 510(k) documentation set properly
- Register the product with the FDA by submitting an application.
You then must pay the relevant fee for 510(k) application review and submit your 510(k) documentation to the FDA. Later you receive confirmation from FDA that your 510(k) documentation was accepted for substantive review. Lastly you will receive a clearance letter from the FDA confirming that your medical device can be legally marketed in the USA. This is because Class II devices receive clearance instead of approval.
Note that if your medical device does not have a predicate device you will need to obtain an FDA premarket approval (PMA). A PMA submission must provide valid scientific evidence collected from human clinical trials showing the device is safe and effective for its intended use.
How long does approval take?
The FDA approval process can take anywhere between a week and eight months, depending on whether you self-register, submit a 510(k) application, or submit a Premarket Approval (PMA) application. Studies show it takes three to seven years in total from concept to approval to bring a medical device to market. This figure is an inclusive measure of the entire device lifecycle, including research & development and testing (not just the FDA approval process).
The length of the approval process depends on the classification of your device. For example Class I devices can take less than two months.
For Class II devices the process is a little longer as most of these require 510(k) clearance. The average length of time for clearance under the traditional 510(k) pathway is 177 days, or nearly six months. The average number of days it takes to clear a device via 510(k) varies according to the device category. Anesthesiology devices have the longest average length to approval, averaging 245 days. Toxicology devices are the shortest on-average, at just 163 days.
Class III medical devices are the most innovative and invasive devices, which potentially present the highest risks to patient health and safety. The majority of Class III devices require PMA. While preparing a PMA application is generally significantly more intensive than a 510(k) app or self-registration, the wait isn’t much longer. According to a report from the FDA, the average PMA application is approved 243 days after submission. That’s just around eight months.
The FDA has been working on improving wait times. Class III medical devices are being approved faster than ever before. Prior to 2010, the average wait for a PMA approval was 345 days or nearly 12 months.
So what is the difference between FDA Approved and FDA Cleared?
FDA approved means that the agency has determined that the "benefits of the product outweigh the known risks for the intended use." Manufacturers must submit a premarket approval (PMA) application and the results of clinical testing in order to get approval.
The FDA is usually inclined to approve a product that has a higher risk if the potential benefit is significant -- like an artificial heart valve that can save someone's life. FDA approval is mandatory to market or sell products such as prescription medications, over-the-counter medications, vaccines and Class III medical devices.
Class I and Class II medical devices are usually "cleared" by the FDA, which means the manufacturer can demonstrate that their product is "substantially equivalent to another (similar) legally marketed device" that already has FDA approval. Those already-cleared products are called a predicate.
Having FDA approval or clearance isn’t just obligatory for some devices, it also gives you an edge when seeking funding. Having FDA clearance shows that you’re a serious medical device manufacturer. The devices that undergo this process have a direct impact in saving lives through diagnosis and treatment. It also lends credibility to your product. The FDA’s mission is protecting the public and safety and efficacy is what they look for when approving a product. If your product is approved or cleared by the FDA, it shows that it has undergone their rigorous quality assurance process and review.
The FDA approval process isn't easy, but it's not impossible. With some research and patience, you can get through it successfully. We hope that this guide has provided some clarity as your company enters this exciting new territory.
This post is the product of extensive research and does not substitute legal advice.
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