Our 510(k) process

The 510(k) pathway

In the United States, medical devices fall into three classes based on risk:

  1. Class 1 – Low risk (cotton swabs, hospital beds)
  2. Class 2 – Medium risk (x-ray, denture resins)
  3. Class 3 – High risk (blood thinners, pacemakers)

510(k) device classification pyramid

As a general rule, manufacturers and importers of Class 2 devices must file a 510(k) Premarket Notification and receive clearance from FDA before marketing their products. Some novel devices follow the De Novo pathway instead.

You can lose months (and longer) if you don’t have expert guidance through this technical process.

How long it takes

FDA takes 90 days to review a 510(k) submission. Add 30 days for preparation of the document and responses to reviewer questions, and the minimum time to receive clearance is four (4) months.

Line graph plotting annual average decision times for 510(k) applications from 2000-2015

Yet most 510(k)s not handled by in-house regulatory staffs take twice as long, and some up to 18 months.

There are two reasons:

  1. Few regulatory consultants have staff dedicated to 510(k)s; and
  2. Busy clients find it hard to direct attention to the project.

We are proud of our focus on 510(k)s, and our track record of keeping clients on task. That means we clear medical devices faster than other regulatory consultants.

What it costs

Cartesian grap of benefit vs. cost

Most clients pay $2,614 for FDA’s review (a few pay twice that amount, depending on their country). Add to that the cost of electrical safety, bio-compatibility, sterilization and performance tests, as appropriate, plus our consulting fee.

If your company is not currently registered with FDA, that annual fee is currently $3,845, which is payable when FDA clears your device. You must also list the medical device(s), which costs nothing.

The biggest expense is the third-party safety & effectiveness tests mentioned above. Once performed, however, they are good for all major markets—and need not be repeated.