If you intend to market you device in the United States, you must comply with FDA requirements and more specifically with the Center for Devices and Radiological Health (CDRH) requirements.

FDA classifies medical devices in one of three classifications depending on the level of risk presented by the device. Devices considered by FDA as posing a low level of risk are classified as Class 1 or Class 2 and generally require the manufacturer to obtain clearance of a Premarket Notification [510(k)] from FDA prior to marketing. Medical devices that do not qualify for 510(k) clearance are classified as Class 3. Such devices are required to undergo a Premarket Application (PMA) process, which is the most stringent type of device marketing application, to prove that they are safe and effective.

PRE-MARKET NOTIFICATION [510(k)]

A submission made to FDA which demonstrates that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device. Submitters must compare their device to one or more similar devices legally marketed in the USA and support their substantial equivalency claims by scientific evidence. The legally marketed device(s) to which equivalence is claimed is commonly known as "predicate device(s)".

PRE-MARKET APPROVAL [PMA]

FDA’s process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a PMA application in order to obtain marketing approval. PMA is the most stringent type of device marketing application required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).

The professionals of Push-Med can assist you with:

• Classification of your device
• Preparation of Investigational Device Exemption (IDE)
• Face-to-face meetings with FDA
• Preparation of a complete and reliable 510(k) submission required for obtaining market clearance
• Guide you through the PMA process
• Design and execute animal and clinical studies

Push-Med is your experienced partner guiding you through the regulatory maze!