What does it mean to be an FDA cleared device?

When evaluating options for helping managing central lines in toddlers it may be important to you to know that the Pediatric Central Line Protector™ has been reviewed by the FDA and cleared as a Class I exempt medical device. But you may wonder what that means? The FDA website provides some great information.

510(k) exempt medical devices: Medical devices that do not require FDA review before the devices are marketed are considered “510(k) exempt.” These medical devices are mostly low-risk, Class I devices and some Class II devices that have been determined not to require a 510(k) (named for a section in the Food, Drug, and Cosmetic Act) to provide a reasonable assurance of safety and effectiveness. These devices are exempt from complying with premarket notification requirements subject to the limitations on exemptions; however, they are not exempt from certain general controls. For example, 510(k) exempt devices must

  • be suitable for their intended use
  • be adequately packaged and properly labeled
  • have establishment registration and device listing forms on file with FDA
  • be manufactured under a quality system (with the exception of a small number of class I devices that are subject only to complaint files and general record keeping requirements)

Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to another legally marketed device. A premarket notification, referred to as a 510(k), must be submitted to FDA for clearance. A 510(k) is most often submitted by the medical device manufacturer. The Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act established three regulatory classes for medical devices. The three classes are based on the degree of control necessary to assure the various types of devices are safe and effective. Class I – These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process. Class II – Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 43% of medical devices fall under this category. Class III – These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category. Exempt – If a device falls into a generic category of exempted Class I devices, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, the manufacturer is required to register their establishment and list their generic product with FDA. Examples of exempt devices are manual stethoscopes, mercury thermometers and bedpans.

When considering your purchase, keep in mind that we’ve made the effort to ensure our product has been reviewed and evaluated by the FDA.