informatics
Medical Device Classification
As per the regulations of Medical Device Amendments of 1976 (MDA, P.L 94-295), Food and Drug Administration classified the medical devices which were on the market . The classifications were based on the risk to patients caused by the use of devices device. Congress had given the definitions for the these classes. The regulations that apply to all FDA regulated medical devices are establishing the registration process from manufacturers, distributors.
Listing of all the devices in right manner as per FDA
Meeting the GMP requirements in process of manufacturing
Proper labeling
Notifying prior to marketing
Class I These devices does not require notification before marketing and the Requirements of QSR. They must meet the requirements of general controls. These are exempted as these devices are considered to be low risk to the patients. FDA assigned product codes of three letters for each device which can be found in product code classification database. The devices belonging to this class are not required for getting the 510(k) clearance.
Examples: bandages, gloves, and hand held surgical instruments
Class II
These includes devices that gives a moderate amount of risk to the patients. The devices classified under this class consists of special controls and the proper information available to lower the cause of risk. The controls were considered to be special labeling requirements, compulsory performance standards, and post market surveillance. For marketing a devices belonging to this class in United States, the manufactures must obtain the clearance of premarket notification through 510(k) process prior to the commercialization. . FDA assigned product codes for each device which can be identified in product code classification database software.
Class II devices are associated with special kind of controls such as Office of Device evaluation (ODE) guidance documents, ISO, and the Quality system requirements.
As per the regulations of Medical Device Amendments of 1976 (MDA, P.L 94-295), Food and Drug Administration classified the medical devices which were on the market . The classifications were based on the risk to patients caused by the use of devices device. Congress had given the definitions for the these classes. The regulations that apply to all FDA regulated medical devices are establishing the registration process from manufacturers, distributors.
Listing of all the devices in right manner as per FDA
Meeting the GMP requirements in process of manufacturing
Proper labeling
Notifying prior to marketing
Class I These devices does not require notification before marketing and the Requirements of QSR. They must meet the requirements of general controls. These are exempted as these devices are considered to be low risk to the patients. FDA assigned product codes of three letters for each device which can be found in product code classification database. The devices belonging to this class are not required for getting the 510(k) clearance.
Examples: bandages, gloves, and hand held surgical instruments
Class II
These includes devices that gives a moderate amount of risk to the patients. The devices classified under this class consists of special controls and the proper information available to lower the cause of risk. The controls were considered to be special labeling requirements, compulsory performance standards, and post market surveillance. For marketing a devices belonging to this class in United States, the manufactures must obtain the clearance of premarket notification through 510(k) process prior to the commercialization. . FDA assigned product codes for each device which can be identified in product code classification database software.
Class II devices are associated with special kind of controls such as Office of Device evaluation (ODE) guidance documents, ISO, and the Quality system requirements.