Medical Device FDA Testing

Views :

Update time : 2026-04-24

The FDA classifies medical devices into three classes (I, II, III), with Class III having the highest risk level. Any medical device intending to enter the U.S. market must first clarify the classification and regulatory requirements of the product applied for marketing.

CTI Testing provides medical device FDA registration and testing services, issuing professional test reports that meet FDA review requirements.

What is the FDA?

• The U.S. Food and Drug Administration (FDA for short) is under the U.S. Department of Health and Human Services. It regulates food, pharmaceuticals, biological products, medical devices, tobacco products, cosmetics, veterinary drugs, etc.

• Based on different risk levels, the FDA categorizes medical devices into three classes (I, II, III), with Class III being the highest risk. The FDA specifies the product classification and regulatory requirements for each medical device. Any medical device seeking access to the U.S. market must first clarify the classification and regulatory requirements of the product to be marketed.

Medical Device FDA Testing(图1)

Testing Services Provided for Medical Devices

• Active Medical Devices: Safety testing, emc testing, fcc testing, packaging & transportation testing, software evaluation & cybersecurity testing, biocompatibility, chemical characterization, etc.

• Passive Medical Devices: Biocompatibility, packaging & transportation testing, aging testing, microbiological testing, sterility validation, etc.

• Laser Radiation Products: Safety testing, EMC testing, FCC testing, etc.

Medical Device FDA Registration & Testing

Active Medical Devices

• Medical Diagnosis & Monitoring Devices: Multi-parameter monitors, electrocardiographs, pulse oximeters, sphygmomanometers, electronic thermometers, infrared thermometers, etc.

• Respiratory, Anesthesia & First-Aid Devices: Household ventilators, medical molecular sieve oxygen generators, household molecular sieve oxygen generators, small medical oxygen generators, portable oxygen generators, medical oxygen concentrators, medical ultrasonic nebulizers, medical compression nebulizers, medical nebulizers, etc.

• Physical Therapy Devices: Nerve and muscle stimulators, low-frequency electrotherapy devices, medium-low frequency therapeutic devices, heating pad therapeutic devices, specific electromagnetic wave therapeutic devices, far-infrared radiation therapeutic devices, infrared thermal radiation physiotherapy lamps, potential therapeutic equipment, red light therapeutic equipment, ultraviolet therapeutic equipment, hair removal devices, etc.

• Medical Device Disinfection & Sterilization Devices: Medical washers, medical ultrasonic cleaners

• Infusion, Nursing & Protective Devices: Medical protective masks, medical surgical masks, disposable medical masks, daily protective masks, respiratory protective air-purifying particulate respirators, children’s masks, knitted masks, etc.

• Patient Support Devices: Manual hospital beds, electric hospital beds, etc.

• Medical Rehabilitation Devices: Hearing aids, wheelchairs, etc.

• Clinical Laboratory Equipment: Centrifuges, nucleic acid extractors, automatic nucleic acid extractors, automatic nucleic acid purifiers, automatic nucleic acid extraction & purification instruments, medical refrigerators, medical freezers, medical refrigerator-freezers, medical ultra-low temperature freezers, sample pre-processing systems, automated sample inspection systems, automatic sample processing systems, sample post-processing systems, aliquoting systems, sample processing & incubation systems, etc.

Passive Medical Devices

• Surgical and orthopedic surgical instruments

• Injection and puncture devices, catheters, etc.

• Family planning appliances, general diagnostic instruments, etc.

• Medical masks, protective clothing, etc.

• Contact lenses, infusion devices, etc.

• Disposable medical supplies and dressings

• Other passive medical device products

Medical Device FDA Testing Standards

Standard Category	Standard Number	Applicable Scope	Main Content
Biocompatibility	ISO 10993 Series	Devices in contact with the human body	Cytotoxicity, sensitization, irritation, blood compatibility, implantation reaction, etc.
Electrical Safety	IEC 60601-1	Active / electrical devices	General requirements for basic safety and essential performance
Electromagnetic Compatibility (EMC)	IEC 60601-1-2	Active / electrical devices	Electromagnetic disturbance immunity and emission requirements
Usability / Human Factors Engineering	IEC 60601-1-6 / IEC 62366-1	Devices with user interfaces	Usability engineering and human factors validation
Software Life Cycle	IEC 62304	Devices containing software	Software development, verification, maintenance and risk management
Sterile Packaging	iso 11607-1 & -2	Sterile devices	Packaging integrity, sterile barrier system validation
Home Care Environment	IEC 60601-1-11	Household devices	Safety requirements for use in non-professional environments
Specific Product Standards	IEC 60601-2-X	Specific device types	e.g., ECG monitoring (2-27), ultrasound (2-37), infusion pumps (2-24), etc.