There are many hurdles to jump over on the path to designing, manufacturing, producing and marketing a medical device. At Pathway NPI, a medical device company here in San Diego, we have guided many clients successfully through the process. 

What Is A Medical Device Declaration of Conformity?

One of the most important steps in the process is ensuring that your device meets all the regulatory requirements for marketing in the United States. One way to do this is to get a declaration of conformity for your medical device from an accredited body.

A declaration of conformity is a written statement from a third-party organization that your product meets all the necessary requirements for safety and performance. This declaration can be used as part of your premarket submission to the FDA.

There are many different types of bodies that can issue a declaration of conformity, but they must be accredited by either the FDA or the ANSI (the American National Standards Institute).

Regulation for Medical Devices

In order to be able to sell your medical device in the United States, you must comply with a number of regulations. The main ones are:

-The FDA’s Good Manufacturing Practices (GMPs)

-The FDA’s Quality System Regulation (QSR)

-The Federal Food, Drug, and Cosmetic Act (FD&C Act)

You can find more information about these regulations on the FDA website.

To help you meet these requirements, we have a team of experienced engineers and quality assurance experts who can guide you through the process and provide support at every stage. We also offer a range of services, including:

-Design Control Services

-Quality System Implementation Services

-FDA Compliance

Prepping a Premarket Submission with Pathway NPI

If you’re considering marketing your device in the United States, we can help you prepare a premarket submission to the FDA. This submission may include a declaration of conformity from an accredited body.

As part of our services, we can help you choose the right body to issue your declaration of conformity and assist with the paperwork. We will also work with you to ensure that your product meets all the necessary regulatory requirements.

510(k) Clearance vs. Approval

A 510(k) is one type of premarket submission that can be handed over to the FDA to demonstrate that a device operates safely and effectively. 

To be able to submit a 510(k), your device must be “substantially equivalent” to another device that is already on the market (known as a predicate device). This means that it must have the same intended use and function as the predicate device, and must have the same technological characteristics.

If your device is not substantially equivalent to a predicate device, you will need to go through the FDA’s premarket approval (PMA) process instead. This is a more complex and time-consuming process, so it’s important to get expert guidance if you’re considering this route.

It is also important to note that there is a big difference between 510(k) clearance and 510(k) approval. Clearance means that the FDA has reviewed your submission and has determined that your device is safe and effective. Approval means that the FDA has not only cleared your device but has also given you permission to market it in the United States.

At Pathway NPI, we have extensive experience with the declaration of conformity submissions and can assist you on your journey — no matter which stage you are in and which type of submission you are working with.

You can also explore our ISO standards for medical devices and our medical device contract manufacturing capabilities. We look forward to working with you!