Medical devices refer to a list of equipment used by doctors, nurses, and licensed technicians every day, in countless numbers medical fields, and in a countless number of situations.
Medical devices can be simple, such as disposable, simple test strips, tongue blades, bedpans, or custom trays, to a complicated and complex heart/lung machine, pacemakers, and everything in between including but not limited to,
Medical devices are necessary tools professionals use on patients every day, such as in the following examples,
According to the FDA, medical devices are categorized into three divisions Class I, II, and III, (low to high risk.) Each class offers risks and FDA regulations, in regards to safety and the effectiveness each display.
For example, the scope of custom trays in the medical arena number to nearly 2,000 types and designs, in all sizes for sterile and nonsterile procedures.
These custom trays make up specific items used in specific procedures. Each item on these custom trays must have an FDA number and be registered.
For example, you are a manufacturer and want to introduce new custom trays on America’s marketplace; you must adhere to a series of steps to attain clearance for the medical device to be sold in the United States. The FDA gives you this permission to sell your custom trays in the United States.
Processed medical devices are devices cleared by the FDA for use on patients. These processed medical devices include proper instructions, labeling, corresponding therapeutic product, generic equivalents, and similar equivalents. The FDA has a comprehensive list of all processed medical devices including custom trays.
Each of these processed medical devices met a stringent definition of that medical tool, no matter its use or branch of medicine.
The FDA considers any medical device that has not gone through the stringent process for registration certification as being an unprocessed medical device, including various types of custom trays.
Medical devices that have not passed through the FDA’s systematic series of actions for certification nor passed a safety test for patient use are considered unprocessed.
Before you put a medical device on the United States marketplace, there are detailed steps you must go through.
When you want to sell a medical device new to the market, you the manufacturer must go through stringent steps to process your their medical device.
These devices can be Class I, II, or III categories. You must file a Premarket Notification with the FDA. While the FDA may not approve this device, the FDA may give you clearance to sell the device in the United States.
If you change a current product such as custom trays, on the market, you must follow this process especially if it changes the way in which the device operates and it’s safety issues.
You must propose the device’s intention for use, design of the instrument, and it’s suitability for the intended purposes as stated. This process helps to categorize the device in the class of I, II, or III. The device receives a specific code and number.
You receive your registration certificate in the form of an FDA post on their government website, for example, your custom trays. This post is your only registration and is now cleared to sell your custom trays.