The Food and Administration (FDA) is the world's first public health protection agency, which is part of the United States (US) government. The FDA regulates medical devices by laws and regulations, so it is also the most strict and serious regulatory system.
In the US, the FDA regulates a wide range of medical devices, such as MRI, CT, medical latex gloves, thermometers, scalpels, wheelchairs, massage apparatus, sex apparatus and other medical and health equipment. Many of the products that are often overlooked, such as toothpicks, toothbrushes, sunglasses, band-aids, sanitary pads, diapers, etc., are regulated and mandated by the FDA as medical devices.
Medical devices are administered by the Food and Drug Administration (FDA) in the United States.
The FDA classifies medical products into three categories with different regulations and controls:
Class I medical devices: general controls, products must meet general regulatory requirements.
Class II medical devices: special control, the products must meet the functional standards.
Class III medical devices: most strictly controlled and must be approved before being marketed.
The above three categories are strict, but are also changeable. If the manufacturer has sufficient grounds to apply to the FDA for a change of Class, the FDA could make (rare) classification adjustments.
For example, in hospital supplies, bandages are in Class I, thermoregulatory water pads are in Class II, and chemical cold packs (snake bite first aid kits) are in Class III. In the physical therapy equipment, Stryker frames are in Class I, physical therapy massagers are in Class II, and ultrasonic muscle syringes are in Class III. All medical devices are defined and classified in detail in federal regulation 21CFR862-895.
Management procedures for medical devices before entering the market
1. Importer registration
The importer must register any kind of medical device with the FDA 30 days prior to its entry into the US. The FDA shall grant a company registration number and designate a unique US agent. This number is required on invoices and bills of lading when importing to the US to facilitate FDA’s customs clearance and entry.
2. Product registration/listing
In addition to the above registration procedures, the FDA also requires manufacturers to register and list devices sold in the US. Same as above, such registration/listing are indicated on the import commercial invoice to facilitate the FDA’s customs clearance.
3. Premarket Notification PMN/FDA510(K)
The PMN/FDA510(K) is referred to as the 510(K) Premarket Notification as it is provided for under Section 510(K) of the federal Act. For any medical device, even if a similar product is already on the market but is new to a manufacturer and first marketed in the US, or if a similar product has previously been marketed with a major or substantial change, it must be reported to the FDA 90 days prior to its marketing and obtain the FDA510(K) Premarket Notification and the FDA510(K) number. The FDA grants a six-digit number preceeded by an alphabetic (for example K432314) before companies and products can be registered. The FDA510(K) demonstration report includes detailed information about the product and the effectiveness and safety that must be stated. This review may also be conducted on behalf of the FDA by an agency submitted to the FDA to authorize a third-party review, but the final approval is made by the FDA. Third party audits will greatly speed up the process to market and reduce audit difficulties.
4. Premarket Approval PMA
For most Class III medical devices of high risks, no matter manufactured domestically or imported, the manufacturer must obtain a Premarket Approval (PMA) before marketing, in which the manufacturer shall demonstrate the safety and effectiveness of the product based on detailed scientific evidence and clinical results. This is the most stringent review that Class III medical devices will have to pass. The cost of the FDA review is also around 2 million yuan, which is unaffordable for many domestic manufacturers if applying by themselves.
Most Class 1 devices and a small portion of Class 2 devices can be directly registered with the FDA;
Most Class 2 devices and a small portion of Class 1 devices shall obtain FDA510(K) approval before registration;
Most Class 3 devices and a small portion of Class 2 devices must be approved by PMA before registration;
The FDA requirements for the quality system of medical device production FDA GMP: 21CFR QSR820
The FDA regulations for the control of the quality system of medical devices are the medical device GOOD MANUFACTURING PRACTICE (GMP) Regulations. Most medical devices manufacturers are not exempted from GMP and must comply with the FDA regulations related to GMP (21CFR820QSR) to avoid manufacturing substandard products.
These regulations have a wide coverage: factory equipment, design, maintenance standards, packaging and Labeling control, workshop maintenance, personnel training, record keeping and so on. The FDA conducts inspections not only at domestic medical device manufacturing factories in the US, but also at GMP factories of manufacturers overseas. This inspection is conducted in the form of spot checks. If serious nonconformance is spotted, a warning will be issued and the relevant products may be immediately detained by the US Customs. Even if a foreign manufacturer is found to be non-conforming to GMP and its products are detained when exporting to the US, it will be removed from the list of automatic detention and normal import treatment will be resumed after improvements are made and verified by the FDA.
Labels and Labeling methods for medical devices
The US requirements on medical equipment and various medical devices are safe and effective. Medical devices marketed in the US must be qualified and properly labelled. Any medical device and medical apparatus must be correctly marked, including name and address of manufacturer or distributor, safety instructions and precautions, and for certain professional devices, it must be clearly indicated that they can only be used by license holders, etc. If the label is false or misleading, or the label is not in English, does not include the content it should have, or does not have sufficient information of operation instructions, warnings or reminders, etc., it is deemed as improper Labeling and will be refused to enter the market.
For example, the fitness balls that we exported to the US claims to treat arthritis and was therefore refused to enter. If the product had been imported in the name of auxiliary hand joint sports equipment, it would be perfectly acceptable, but if it claimed to have therapeutical efficacy, it was then classified as medical apparatus. The product had falsy Labeling without sufficient scientific grounds and clinical evidence and was not managed as medical devices, which was then refused to enter the US market.
Technical regulations in relation to medical devices
The classification of medical devices is detailed in Article 21, Food and Medicine of the Code of Federal Regulation.
21CFR803 Medical device reporting
21CFR806 Medical device; report of corrections and removals
21CFR807 Establishment registration and device listing for manufacturers and initial importers of devices
21CFR808 Exemptions from federal preemption of state and local medical device requirements
21CFR809 In vitro diagnostic products for human use
21CFR810 Medical device recall authority
21CFR812 Investigational device exemptions
21CFR814 Premarket approval of medical devices
21CFR820 Quality system regulation
21CFR821 Medical devices tracking requirements
21CFR860 Medical devices classification procedures
21CFR861 Procedures for performance standards development
21CFR868 Anesthesiology devices
21CFR870 Cardiovascular devices
21CFR872 Dental devices
21CFR874 Ear, nose and throat devices
21CFR876 Gastroenterology-urology devices
21CFR878 General and plastic surgery devices
21CFR880 General hospital and personal use devices
21CFR882 Neurological devices
21CFR884 Obstetrical and gynecological devices
21CFR886 Ophthalmic devices
21CFR895 Ligation devices
21CFR888 Orthopedic devices
21CFR890 Physical medicine devices
21CFR892 Radiology devices
21CFR895 Ligation devices
21CFR898 Performance standard for electrode lead wires and patient cables
21CFR862 Clinical chemistry and clinical toxicology devices
21CFR864 Hematology and pathology devices
21CFR866 Immunology and microbiology devices