If your company makes medical devices, you must register with the U.S. Food and Drug Administration. This registration is not a sign of approval by the FDA; it's a separate process that alerts the FDA to where the device is manufactured. It may seem very odd to register a device even when it's not approved, especially because you'd think the approval process would include the paperwork that shows where it was manufactured. It does, but remember that a number of drugs and devices can get emergency authorization even if they're not fully approved. So, the FDA needs a separate registration for your facility and devices to ensure it has the location, for very good reasons.

Register Once but Keep Updating

This is important: You'll register once, but then you'll keep updating the registration. For example, if you open a new factory in a neighboring city and move the manufacture of a registered device to that new factory, you'll need to update the registration for that device. Remember all address changes as well.

Assist With Natural Disaster Planning

One of the major reasons why you want to do this is so that if there's a public emergency, such as a natural disaster, in the area where the device is made, the FDA knows that the disaster will affect the manufacture of the device. If this is something that people are using off-label or under an emergency authorization, then the FDA knows that they have to keep an eye out for substitute items or warn the public and doctors that the device may suffer a shortage. If you end up closing a location due to a disaster and open a new one, remember to update your registration.

Adhere to Local and Federal Rules

While some states leave medical device registration up to the FDA, others have additional requirements. California, for example, requires licensing to make and sell medical devices. If the FDA is aware of where your devices are manufactured, then the department knows what other regulations you have to follow.

If you're not sure of the next steps to take for a new medical device company, you may want to consult with an FDA Certification Registration Services company and attorneys who can guide you through the process of filling out the correct registration forms. These consultants can ensure that you're using the correct terms to describe your FDA approval or the status of your application for approval.