Waqas Imam As a medical device manufacturer, even if you don’t have the ISO 13485 certification, you have to comply with the applicable regulatory requirements to market your products. Compliance with regulatory requirements is given equal importance in ISO 13485, with the latest version putting additional emphasis on this factor. The Food and Drug Administration (FDA) is a federal agency of the United States of America – responsible for safeguarding and maintaining public health through the regulation and supervision of medical devices and other products. The Center for Devices and Radiological Health (CDRH) is the authority for regulating and approving medical devices under the domain of the FDA.
In 1976, the Federal Food, Drug and Cosmetic Act was revised. Under this revision, the Medical Device section was also amended, instituting three regulatory classes for medical devices. The three classes are based on the extent of control required to guarantee that the devices are safe to use and effective for their intended functions.
Regulatory classes for medical devices
The classification procedure and market approval processes are fully explained in the 21 CFR Part 860 (Code of Federal Regulations for Medical Device Classification Procedures). The FDA, in the United States, permits devices to access the market through two regulated paths. The easiest and most widely used is the 510(k) process (which is titled after the CFR section). When a supplier can prove that its newly designed device is equivalent to a former officially supplied medical device, it can access the market with the permission of the FDA as long as the defined controls required in this process are met. The 510(k) process doesn’t involve the high level of testing that clinical trials require.
The other path to the marketplace is the Premarket Approval (PMA) process, which requires approval by the FDA. Following are the classes of medical devices:
Class I – Devices placed into Class I offer the least potential for harm to the user and/or the patient. These devices generally have a simpler design than those devices that fall into the other two classes. Class I devices are not designed to assist or support life and, as such, are unlikely to pose any significant risk of illness or injury. Hand-held surgical instruments, elastic bandages, mercury thermometers, and examination gloves are some examples of Class I devices.
Within Class I, if a device is classified into a general category of exempted devices, then no Premarket Notification application or FDA clearance is needed before selling the device in the U.S. But, the supplier is mandated to register its institution and submit a list of generic products to the FDA. These Class I devices are under the fewest regulatory controls. Class I devices that are not listed as exempted devices undergo a Premarket Notification application with the FDA. This Premarket Notification application is also applicable for Class II devices.
Class II – These devices are more sensitive in terms of life support than those in Class I. Devices in Class II are controlled with a higher level of assurance than Class I devices, and are regulated by the FDA to ensure that they perform their intended functions well without resulting in any injury or damage to the patient or user. Some examples of Class II devices are infusion pumps, acupuncture needles, air purifiers, powered wheelchairs, pregnancy test kits, and surgical drapes.
The Food, Drug and Cosmetic Act under Section 510(k) mandates that medical device suppliers who want to sell their devices in the Class II category must submit registration showing their intent to market a device. This process of application submission is known as the Premarket Notification (PMN), and is also referred to as 510(k). Under this section the supplier has to convince the FDA that the new device is as safe and effective as one of the devices already marketed with FDA approval. If the FDA recognizes the application of that device as “substantially equivalent” to a device already on the market, the supplier can then market that approved device. You can also search for devices in the FDA’s 510(k) Premarket Notification searchable database to confirm that the device is already approved for the market, or was on the market before 1976.
Class III – Class III devices are the most critical devices, designed to assist or support life. These devices include implants, and carry a high risk of injury or illness. Examples of Class III devices include implantable pacemakers, HIV diagnostic tests, pulse generators, automated external defibrillators, and breast implants.
Class III devices are routed through Premarket Approval (PMA). PMA is the most effective control of the FDA. Any new medical devices, based on new materials or containing a different design from what was previously marketed, are mandated to submit a Premarket Approval application. The application for approval must show justification gathered from clinical trials on humans proving that the medical products are safe to use and perform their intended functions. You can also search for devices in the development phase in the FDA’s Premarket Approval searchable database to confirm that your device is critical for human life.
Significance of classes for medical device manufacturers and suppliers
ISO 13485 helps you to build a Quality Management System with the necessary considerations for the (above-mentioned) regulatory requirements. The FDA’s CDRH, through three different medical device classes, keeps strict control over the medical device market in the United States. Devices that are the least harmful (e.g., elastic bandages, mercury thermometers) do not require protocols to validate their safety and effectiveness. Devices whose designs are already established as fit for purpose and safe for use undergo a simple notification process that usually does not require clinical trials, just an expression of equivalence with a previously approved and marketed device.
Devices that are critical for life are categorized in Class III and undergo a detailed process of approval under which clinical trials are done. The results of clinical trials are kept confidential. Thus, the FDA has minimized the possibility of defective and life-threatening devices coming to market. It is important for the well-being of the people that devices are regulated. State authorities can keep control over devices effectively in this way.
Use this free Diagram of ISO 13485:2016 Implementation Process in order to use ISO 13485 for the FDA approval process.
