The United States Food and Drug Administration (FDA) oversee European Authorized Representative (Non European) medical device companies that must comply with the Center for Radiological Devices and Health (CDRH) while selling medical devices in the US market. The FDA regulates EU representative (Non european country) medical device products and companies that manufacture, repackage, relabel or import medical devices sold in the United States.
The FDA classifies the medical device into the following classes: Class I, II and III with regulatory controls increasing from Class 1 medical device to class 3 medical device. The FDA classification for Medical Device Classification according to the specific requirements for each device is as follows:
-Class I devices are exempt from pre-market notification.
-Class II devices require 510 (k) premarket notification
-Class III devices require premarket approval (PMA)
US FDA Consultants can assist you with the classification of a potentially marketable medical device using FDA guidelines. Compressing FDA rules and regulations regarding the three different classes can be complex, but necessary to determine the future of a device.
The attorneys at the US FDA Consultants advise and represent medical device companies on marketing requirements including:
FDA regulations on labeling of medical devices
Registration of medical device installation with the FDA
FDA advertising and marketing regulations for medical devices
Withdrawals of medical devices
FDA Inspections and Corrective Action Plans
Represent FDA medical device companies against the FTC and NAD
Compliance in import and export
Preparation and presentation of the 510K pre-market notification of medical devices
Quality System Regulation
Medical Device Reporting (MDR)
Biocompatibility testing
If you are searching the market for a new medical device, introducing an existing medical device to the US market that is currently marketed in a foreign jurisdiction, you have received a warning letter from the FDA, or any other FDA compliance issue, Contact US FDA Consultants for a consultation and to discuss the future of your medical device within the US market and for FDA Certificate (India).
FDA Registration (India) purposes, medical devices are classified according to the degree of risk they represent, which is evaluated according to the time of contact with the human body, the degree of invasiveness, if it releases drugs for the patient, if it is used in combination with other medication or device.
In US, they are grouped into three classes, where Class I corresponds to those devices with the lowest risk for the organism, those inputs whose safety and efficacy are fully evaluated, are generally devices that are not introduced into the human body.
Class II: Represents those inputs that may have variations in their elaboration or concentration, are introduced to the human body for a period of less than 30 days.
Class III: Those inputs that are introduced into the body, and that remain in the body for periods longer than 30 days. It is worth mentioning that the latter devices have increased their production due to technological medical advancement, as the companies that distribute them have innovated in such a way that their position in America has increased along with scientific advances and new technologies of developing. An example of this are those mono-implants that seek to regulate the functioning of internal human organs.
