Every medical device manufacturer marketing products in the USA, must go through the process of classifying their devices according to the US Food and Drug Administration (FDA) specifications. In this article we take a look at the basic things to know about, as well as drawing an outline of the FDA medical device classification process.
This process is defined by the FDA in Title 21 of the Code of Federal Regulations (CFR), in which approximately 1,700 types of medical devices are grouped into 16 different medical specialties (or panels). For each type of device one of three regulatory classes is assigned, based on the risk categorization and consequently, the level of controls necessary to assure device safety and effectiveness.
Determining the correct classification of your medical device is of crucial importance in all stages of the device’s life cycle. The classification of your device will determine the regulatory requirements that you need to meet, in order to market said device to the USA. Moreover, knowing the correct classification and complying with general and special controls will save you a lot of resources. First, necessary steps will be taken to make a compliant product from early stages, avoiding costly revisions; and second, complete documentation ensuring compliance will be readily available, resulting in timely review decisions and quicker medical device approval by the FDA. In conclusion, proper search of medical device classification is a big part of overall successful results.
The FDA defines a medical device as any product that is used in healthcare and does not achieve its purposes by chemical action or metabolization (section 201(h) of the FDCA). This definition excludes all drugs and pharmaceuticals, while including the full range of medical devices: from as simple as a tongue depressor, to as complex as a robotic surgery device, and everything in between.
Devices are organized into a total of 16 comprehensive medical specialty “panels”, which are: Anesthesiology, Cardiovascular, Chemistry, Dental, Ear Nose and Throat, Gastroenterology and Urology, General and Plastic Surgery, General Hospital, Hematology, Immunology, Microbiology, Neurology, Obstetrical and Gynecological, Ophthalmic, Orthopedic, Pathology, Physical Medicine, Radiology, Toxicology.
All 1,700 different types of medical devices are categorized according to their risk factor into 3 different classes. This classification then determines the extent of regulatory controls, according to a risk-based approach, as follows.
These are the first level of controls, with the least amount of regulatory control whenever the level of device risk is low. Examples of general controls include: adulteration or misbranding, device electronic establishment registration and listing, premarket notification, quality systems, medical device reporting, and labeling.
This is the second level of controls, applicable when general controls alone are insufficient to assure safety and effectiveness. Examples of special controls include: device guidelines & manuals, adhering to a mandatory performance standard, recommendations or other actions, and special labeling.
Premarket Approval (PMA)
Premarket approval is necessary whenever general or special controls cannot provide sufficient information to ensure medical device safety and effectiveness. Examples of PMA controls include: clinical investigations, safety and effectiveness data, adverse reactions and complications, patient information, and many more according to the type of device.
Device examples: Heart valves, implantable neuromuscular stimulator. By default all novel medical devices that have not been previously classified, belong to this category.
If you intend to introduce a device to the US market which does not require the standard PMA, you will have to submit a 510(k). The 510(k) is a FDA premarket submission in which the device to be marketed is compared to a similar device that has been legally marketed prior to May 28, 1976. The new device must be proven to be at least as safe and effective as the predicate.
To determine your device’s classification, as well as any exemptions that may exist, you need to find the regulation number corresponding to the classification regulation for your device. To accomplish this, you may use either of the following methods: