What is the FDA Approval or Clearance Process for Medical Devices?

The process of medical device creation involves several intensive and complicated steps that manufacturers must go through before having their products sold to patients on the open market. The most complex of these steps is acquiring Food and Drug Administration (FDA) approval for their new device. In the article below, our medical device experts at Global Strategic Solutions will explore what the FDA approval or clearance process entails, how long it typically takes, and how manufacturers should approach the process for the best possible chance at initial device approval or clearance.

Related: 3 Questions That Can Define Your Medical Device User Needs

Medical Device Approval or Clearance: The Three Basic Pathways to Know

Medical devices - including instruments, machines, apparatuses, implementations, and in vitro reagents- are highly regulated by the FDA’s Center for Devices and Radiological Health (CDRH) . The pathway to approval for a medical device depends on its risk classification. Medical devices must go through one of three pathways after development, testing, and, if needed, clinical trials to acquire FDA approval or clearance for market access and sale. The three basic processes to obtain FDA marketing approval depend on the device’s nature and circumstances involving why FDA submission is needed. These include;

1.???Premarket Approval

Premarket approval (PMA) is the strictest device marketing application process for medical devices and is required for those with no existing predicate or equivalent on the market. As part of a PMA, devices must demonstrate sufficient scientific evidence that they are safe and effective for their intended use. There is a range of clinical evidence requirement levels needed for PMA. After a PMA application is submitted, the FDA will determine whether or not the application is sufficient to undergo a substantive review before final approval. The FDA encourages manufacturers to establish early contact and collaboration with appropriate review boards during pre-submission or Q-sub meetings to help streamline the process.

Related: How to Prepare a Traditional 510(k) Submission

2.???Pre-Marketing Notification & The 510(k) Application

Pre-marketing notification (PMN) - also known as the 510(k) application, is a fast-track process for FDA approval and is used for devices that serve as a substantial equivalent to another device already approved for market sale. Suppose the FDA determines the device has an acceptable predicate. In that case, a PMA is not needed, and the device will eventually undergo a final review before it is cleared for market access.

3.???The Humanitarian Device Exemption

The humanitarian device exemption (HDE) is used for devices expected to diagnose or treat conditions that affect less than 4,000 individuals annually in the U.S. This pathway is handled by the FDA’s Office of Orphan Products Development . HDE applications and approval are similar to PMA but do not require scientific evidence of efficacy. Sponsors are only required to show that the device has a potential health benefit and that said benefits outweigh the risk of possible illness or injury. After obtaining designation as a humanitarian use device (HUD), a final HDE review process will occur.

Even if your company develops a revolutionary medical device that will change the lives of countless consumers for the better, you’ll still need to get FDA approval before putting it on the market. Thankfully, our experts at Global Strategic Solutions are here to help!

Medical Device Classifications and Approval Wait Times?

The pathway your device will need to go through primarily depends on your device’s medical class , which can range from Class 1 to Class 3.

●?????Class 1 Devices: Represent the lowest risk to patients and are typically exempt from the 510(k) clearance pathway. They include non-invasive items like electric toothbrushes, oxygen masks, and tongue depressors. These devices undergo the fastest path to FDA market approval, and registration may be completed in as little as one week. Class I devices are subject to the least regulatory control.

●?????Class 2 Devices: Represent 43% of all medical device applications and carry moderate risk. They include devices like syringes, catheters, and contact lenses. Most Class 2 devices require a 510(k) application, and manufacturers can demonstrate the device’s efficacy and safety through substantial equivalence. The average time for Class 2 device approval is 177 days, or about six months. There is a lot of variability in approval time. Selecting a predicate device with the same three-letter classification product code as the proposed device is usually the most appropriate. Suppose you need assistance choosing a predicate device or obtaining a more accurate assessment of approval times. Global Strategic Solutions, LLC here in the Silicon Valley area of California can help.

●?????Class 3 Devices: Represent the most invasive and innovative devices, and present the highest potential risk to patient health and safety. They account for approximately 10% of all medical devices, including implants, prostheses, and defibrillators. The average PMA application takes an average of 243 days for approval post-submission or just over eight months.

Obtaining FDA Approval or Clearance For Your Medical Device: Key Step Overview

No matter what class of device your company develops, there are six key steps typically involved in the overall process involved with acquiring FDA approval for market sale.

1. Classify your device as Class 1, 2, or 3.
2. Select your premarket submission pathway.
3. Conduct clinical trials if your device requires a complete PMA.
4. Prepare the needed application for your device.
5. Submit your device FDA application.
6. Register your device and establishment with the United States.

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Final Factors to Note: How Global Strategic Solutions Can Help Get Your Device FDA Approved

Whether your newly developed medical device is categorized as Class 1, 2, or 3, and no matter what path to FDA approval your company undergoes, you’re likely to encounter a range of potential hang-ups without the help of an experienced consultant in the field.

Thankfully, our team of medical device experts at Global Strategic Solutions is here to help make the process as straightforward as possible to get the approval you need to launch your new product onto the market without any substantial delays. Please consider contacting us today to learn about everything we can do for your company. Also, consider reading through our wide selection of other expertly written resources for more information.

Is your company currently struggling to get a series of new medical devices approved for sale by the FDA? Please consider reaching out to our team of trusted experts at Global Strategic Solutions today to learn about our range of top-quality services.?

David R Rutledge, Pharm.D., FCCP, FAHA

+1 (630) 846-0350 cell

www.GlobalStrategicSolutions.com

[email protected]