How to take the headache out of the FDA approval process for medical devices

Simplify meeting FDA clearance requirements for medical devices

Arguably the biggest hurdle to overcome when taking a new medical device to market in the United States is getting your premarket approval. You and your product design company must imbue every step of your process with the necessary regulatory and compliance requirements to ensure the FDA submission process will be a smooth one.

The FDA submission process in a nutshell

Getting premarket approval largely depends on the classification of your medical device. This broadly comes in three categories:

  • Class III: these are defined as  a device that ‘supports or sustains human life or is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury “. Class III devices are the most heavily regulated as these new devices generally do not have existing equivalents. Replacement heart valves are classified in this tier.
  • Class II: these moderate risk devices require greater control than the lowest tier to ensure a device’s safety and effectiveness. An example of a class 2 device would be the condom.
  • Class I devices are low-risk and require the least regulatory controls. Dental floss is an example of class I.

Class I and II can be fast-tracked for clearance through a premarketing notification process known as a 510(k) submission. The implication of this type of submission is that your medical device’s purpose lies within acceptable proximity to a previously approved equivalent product.

FDA clearance: some facts and figures

In a study published by the Emergo group, it is shown that in 2016, 2957 of FDA 510(k) submissions were cleared. When looking at the timeline from submission to clearance, the same study shows that it took up to six months to get the FDA clearance. Using  a third party reviewer, it went down to 4 months.

Reasons for clearance denial

Getting your 510(k) submission denied is a costly and time-consuming setback. Some of the common mistakes made when submitting are:

  • No biocompatibility data and shelf-life information.
    The FDA will want to know why you did not submit that information, even if it doesn’t apply to your device.
  • Not heeding previous feedback.
    This goes beyond submitting your device anew with amendments, the FDA’s comments and questions must be acknowledged and responded to accordingly.
  • Not including full test reports.
    The FDA will want more than just a list of tests, it must be comprehensive and include all variables and conclusions.

There are other examples such as forgetting to highlight labeling changes or being vague when describing how your device will be marketed, but it is clear that you or your product design company need to thoroughly prepare any submission.

Start early to avoid hassle

The FDA requirements for a 510(k) submission process are freely obtainable on the FDA website. With this information, you can make an informed decision as to how you are going to tackle the process. You will be able to define if you have the resources and know-how needed to develop a prototype that is going to be in line with FDA regulations. Alternatively, you can call upon a product design company that can help you streamline your processes, all the while keeping FDA regulations in mind.

Technosoft is just such a product design company. We specialize in in-house prototyping, manufacturing, testing and clinical trials for medical devices. By outsourcing your product development to us, you benefit from our years of experience as a product design company, which includes applying for 510(k) submissions. We will help you design a compliant product that will be easy to take to market by attracting investors who know they will get the best return on investment possible.

To know more: download our guide

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