How Does The FDA Regulate Medical Devices?
The Center for Devices and Radiological Health, or CDRH, is responsible for regulating firms that manufacturer, repackage, and relabel medical devices made in the United States. The CDRH also regulates radiation-emitting electronic products such as lasers, x-rays, ultrasound equipment, microwave ovens, and color televisions.
Establish Registration
There are seven different areas that manufacturers must comply with that are not extremely confusing to remember. All manufacturers and importers of medical devices have to register their establishment with the FDA. All registration information must be verified annually between the 1st of October and the 31st of December.
Medical Device Listings
The FDA must receive a list of all devices that a manufacturer decides to produce. Along with the name of the item, you will need to gather all manufacturers that are used for the item. Next, the contract manufacturers’ needs recorded. After you have found all the suppliers, the contract sterilizers need added as well. Specification developers, repackagers, relabelers, reprocessors, and remanufactures should round out the essentials. An accessory manufacturer is also needed as well as any of your U.S. manufacturers that you plan to have to “export only”.
Premarket Notification 510(k)
A submission will need recorded of your Premarket Notification 510(k). You must be able to demonstrate how the device works and how it is substantially equivalent. Your job is to prove that your product is similar to one that is already on the market while offering something new as well. The Medical Device User Fee and Modernization Act of 2002 authorized the FDA to charge a fee for medical devices.
Premarket Approval
If you have an item that needs a Premarket Approval, or PMA, it is likely it is a Class III high risk device. There is a significant risk of injury or illness. The process of PMA is much more involved and includes the submission of data and a statement.
Investigational Device Exemption
An Investigational Device Exemption, or IDE, allows the investigational device to be used in a clinical study in order to collect data to support a Premarket Approval application or a Premarket Notification 504(k) submission to the FDA. Clinical studies with medical devices proved to go quickly. If approved by the FDA, an Institutional Review Board, or IRB, will need to approve as well.
Establish Registration
There are seven different areas that manufacturers must comply with that are not extremely confusing to remember. All manufacturers and importers of medical devices have to register their establishment with the FDA. All registration information must be verified annually between the 1st of October and the 31st of December.
Medical Device Listings
The FDA must receive a list of all devices that a manufacturer decides to produce. Along with the name of the item, you will need to gather all manufacturers that are used for the item. Next, the contract manufacturers’ needs recorded. After you have found all the suppliers, the contract sterilizers need added as well. Specification developers, repackagers, relabelers, reprocessors, and remanufactures should round out the essentials. An accessory manufacturer is also needed as well as any of your U.S. manufacturers that you plan to have to “export only”.
Premarket Notification 510(k)
A submission will need recorded of your Premarket Notification 510(k). You must be able to demonstrate how the device works and how it is substantially equivalent. Your job is to prove that your product is similar to one that is already on the market while offering something new as well. The Medical Device User Fee and Modernization Act of 2002 authorized the FDA to charge a fee for medical devices.
Premarket Approval
If you have an item that needs a Premarket Approval, or PMA, it is likely it is a Class III high risk device. There is a significant risk of injury or illness. The process of PMA is much more involved and includes the submission of data and a statement.
Investigational Device Exemption
An Investigational Device Exemption, or IDE, allows the investigational device to be used in a clinical study in order to collect data to support a Premarket Approval application or a Premarket Notification 504(k) submission to the FDA. Clinical studies with medical devices proved to go quickly. If approved by the FDA, an Institutional Review Board, or IRB, will need to approve as well.