Contact Us
Close Form

Interested in learning more about how we can work together in your current or next medical device design project?

Just fill out this form and we’ll be in touch!

  • This field is for validation purposes and should be left unchanged.

Wherever you are in your product development lifecycle,
Sterling can help.

P: 201-877-5682
F: 201-301-9169

Things You Should Know About Medical Device Development

Author: Bruce Swope | Date: November 12, 2012

Thought Leadership: Getting Your Medical Device through the FDA Approval Process

Designing, developing and bringing to market a new medical device is a complex process. Here are some of the things you need to know about the medical device FDA approval process:

FDA and CE Regulations:

medical device FDA approval process

Medical devices are covered by FDA regulations in the US and by Medical Device Directives in European Union (EU) countries. Technically, the FDA does not “approve” Class 1 and 2 and some Class 3 medical devices for sale in the US. Instead, they give “clearance” for them to be sold.

The two major processes by which medical devices requires FDA review are:

  • “Premarket Notification” which is commonly known as the “510(k) process.”
  • “Premarket Approval” which is also know by its submission acronym, “PMA.”

In order to be eligible for 510(k) clearance, a new device must exhibit roughly the same safety and effectiveness characteristics as a “predicate” device to which the new one is being compared. The PMA process, on the other hand, is based on a demonstration of safety and effectiveness through “adequate and well-controlled” clinical trials. A successful PMA submission results in approval of the new device. An excellent discussion of the differences between 510(k) and PMA can be found at

While the FDA requires evidence of both safety and efficacy of a device, a European CE Mark requires only proof of safety and that the device performs in a manner consistent with the manufacturer’s intended use. As a result, FDA Clearance can require as long as 3 years while CEO Marking can usually be obtained in a much shorter time., leading to considerable discussion regarding which path should be sought first. An excellent discussion of this topic can be found at

How to Get Your Device through the FDA Process:

Obtaining FDA clearance can be a long and arduous process. It often involves many subjective decisions regarding safety and efficacy. As a result, it is strongly recommended that you engage the services of a reputable submission consultant to help develop a strategy at an early stage. A list of submission consultants can be found simply by typing “FDA Submission Consultants” into the Google search engine.

Throughout the process, it is very important to maintain open communication, getting the FDA involved as early as possible and understanding where your device fits and what they are looking for. It is also important not to overcomplicate the documentation, but rather to stick to the facts and keep it as simple and straightforward as possible. The submission consultant you select can provide valuable assistance with this.

Discover more insights about the medical device FDA process in our informative white paper, “The Common Pitfalls of the Medical Device FDA Submission Process.”

Share this!

Contact Us

  • This field is for validation purposes and should be left unchanged.


technician manufacturing medical devices

July 21, 2021

Good Manufacturing Practices for Medical Devices: Risk Management

The clients we work with at Sterling Medical Devices often know they want to produce a high-quality medical device, but unfortunately too often do not fully understand an element essential to good...
Read More >
View More Blogs

February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
Read More >
View More Videos

July 12, 2022

Scalp Cooling System

Overview Paxman has been pioneering scalp cooling technology for over a quarter of a century. Paxman’s clinically proven cold cap technology has helped over 100,000 cancer patients in more than 60...
Read More >
View More Case Studies

Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
Request Free Analysis