Do All Medical Devices Need FDA Approval?

Background Information

The US Food and Drug Administration (FDA) regulates and supervises the safety of foods, dietary supplements, and a host of medical treatments which includes drugs, vaccines, cosmetics, etc. The body within the FDA that is responsible for ensuring the safety of all FDA medical devices and eliminating unnecessary exposure to radiation-emitting products is the Center for Devices and Radiological Health (CDRH).

The CDRH consists of a team of multifaceted professionals who are highly skilled and dedicated. These include scientists, biologists, chemists, etc. They check the medical application devices for their risks and benefits, and once deemed safe and effective, continue to ensure that once-in-the-market devices remain the same.

FDA medical devices are defined as “any instrument, machine, contrivance, implant, in vitro reagent that’s intended to treat, cure, prevent, mitigate, and diagnose disease in man”. Some examples include thermometers, tools used by optometrists like the vision screener from Depisteo, or even an advanced robotic surgical device. FDA also says that the device does not achieve its purpose by chemical activation or metabolizing within the body. If it does any of these two, then it will be considered and regulated by the FDA as a drug (medicine).

The FDA medical devices have been classified into 3 classes as Class I, Class II and Class III. FDA has classified about 1700 devices so far. The different classes stand for the following

Class I: They are low-risk devices. There are about 780 such devices.

Class II: They are medium-moderate risk devices. There are about 800 such medical devices.

Class III: They are of high risk, generally life-supporting and life-sustaining. There are about 120 of them and each requires pre-marketing approval.

Here are the different regulations for FDA medical devices:

Pre-marketing notification or 501(k) program

The purpose of this is to demonstrate that a medical device is substantially equivalent to another device that is already legally marketed. Most Class I devices are exempted from this but some need to submit it. All Class II devices that do not require pre-marketing approval need to submit 501(k) notification. Each device that has a 501(k) notification needs clearance by the FDA before commercial marketing.

Establishment Registration and Medical Device Listing

For all finished device manufacturers and importers of medical devices, this is a requirement. Manufacturers must register their medical devices with the FDA when they plan to market their devices. Manufacturers outside the US must also register their devices and name a US agent for their foreign establishment.

Pre-marketing approval

All class III devices of high risk, some class II and class I devices which are not substantially equivalent or have been rejected 501(k) require pre-marketing approval. It is a tough requirement and requires a lot of scientific evidence that proves the device is safe and effective. Manufacturers should get approval before marketing their devices.

Quality systems regulations

This is the FDA current food manufacturing practice. It specifies the entire regulatory requirement with respect to purchasing, designing, manufacturing, packaging & labeling, storing, installing and servicing of the devices. Manufacturers must adhere to these requirements.

Medical device labeling

This is with regard to the labels on the device. It lays out rules about the instructions for the use, advertising, or promotional material that are printed on the label. For example, spirometer testing guidelines (A spirometer is a device used to test lung function, like the spirometer by Depisteo). The labeling must not be misleading or false while being marketed. This will lead to misbranding, which is a violation of the Federal food, drug, and cosmetic act. This gives the FDA assurance that the medical device is manufactured consistently with the specifications during the clearance or approval.

Medical device reporting

It is a system that the FDA has in place to report any adverse events with respect to a medical device. An adverse event may be a malfunction of the device, which may cause an injury or death. Manufacturers, user facilities, and importers of devices are required to report any case of an adverse event. This helps to monitor the safety of the device and provide timely interventions and corrections to prevent any hazards.

Investigational device exemption (IDE)

 In this program, the FDA requires unapproved medical devices to be approved for clinical studies on human subjects for safety and efficacy purposes. If the device is of significant risk, it requires both the approval of the FDA and an institutional review board (IRB). If the device is of non-significant risk, it only needs the approval of the IRB.

Thus, FDA medical devices must follow stringent rules and regulations before being marketed for personal or commercial use to ensure patient safety of the highest standard.