PCB Tutorial
Lesson 7 — Coding Medical Device, In Vitro Diagnostic and Non-Medical Radiation Emitting Products
On This Page
Medical Device and In Vitro Diagnostic Products — Industry Codes 73 – 92
Product codes for medical devices and in vitro diagnostic products can be found by searching the Food and Drug Administration (FDA) "Product Classification" database. The codes for medical devices and in vitro diagnostic products are the responsibility of FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). For more information on how medical device product codes are used, review the Guidance for Industry and FDA Staff "Classification Names for Medical Devices and In Vitro Diagnostic Products" document.
Products are identified by a product code that consists of five characters (2 numeric, 3 alpha). The first two digits indicate the industry code which corresponds to the review panel under which the device or in vitro diagnostic product was originally classified. Click on the drop down list to see the different review panels and their industry codes.
| 73 | Anesthesiology |
| 74 | Cardiovascular |
| 75 | Chemistry |
| 76 | Dental |
| 77 | Ear, Nose and Throat |
| 78 | Gastroenterology and Urology |
| 79 | General and Plastic Surgery |
| 80 | General Hospital |
| 81 | Hematology |
| 82 | Immunology |
| 83 | Microbiology |
| 84 | Neurology |
| 85 | Obstetrics and Gynecology |
| 86 | Ophthalmic |
| 87 | Orthopedics |
| 88 | Pathology |
| 89 | Physical Medicine |
| 90 | Radiology |
| 91 | Toxicology |
| 92 | Molecular Genetics |
The three alpha characters represent the product classification code assigned by CDRH. The first alpha character of the product classification code goes under Product Class. However, this does not give the Product Class any specific meaning. The last two letters of the product classification code go under Product. Subclass and PIC codes are not used for these products; hyphens are entered in those two fields.
Example: Medical Device
Product: Kit, First Aid
Product Code: 79L — RR
| INDUSTRY | CLASS | SUBCLASS | PROCESS INDICATOR CODE (PIC) | PRODUCT |
|---|---|---|---|---|
| Number | Letter | Letter or "-" | Letter or "-" | Letter or Number |
| 79 | L | — | — | RR |
| General & Plastic Surgery | no meaning | Kit, First Aid |
Foreign manufacturers are required to list with the FDA the medical devices that they manufacture for export to the United States (21 CFR Part 807). The listing information should include the three-letter product code assigned by CDRH. It will not include the two number Industry Code.
When you are determining the product code for medical devices, try searching the product classification database for the name of the product first. If your first search does not provide the description of the product you are attempting to code, try searching for other key words that describe the product type. This process should lead you to the correct product code. Then use the review panel information provided in the product classification database to determine the industry code.
Definitions of device classification panels
Below is a brief definition of the industry code terms.
Anesthesiology: the branch of medical science that studies and applies anesthetics. Anesthetics are drugs that cause temporary loss of bodily sensations with or without loss of consciousness.
Cardiovascular: of, relating to, or involving the heart and the blood vessels.
Chemistry: the science of the composition, structure, properties, and reactions of matter, especially of atomic and molecular systems.
Dental: of or pertaining to the teeth or to dentistry; as, dental surgery.
Ear, Nose and Throat: the branch of medicine that deals with diagnosis and treatment of diseases of the ear, nose, and throat.
Gastroenterology and Urology: Gastroenterology is the branch of medicine that deals with the study of disorders affecting the stomach, intestines, and associated organs. Urology is the branch of medicine that deals with the diagnosis and treatment of diseases of the urinary tract and urogenital system.
General and Plastic Surgery: General Surgery is the branch of medicine that deals with the diagnosis and treatment of injury, deformity, and disease by manual and instrumental means. Plastic Surgery is surgery to remodel, repair, or restore body parts, especially by the transfer of tissue.
General Hospital: refers to general products not ascribed to a particular medical specialty used in a hospital or physician's office such as examination gloves, disinfectants, tongue depressors, etc.
Hematology: the science encompassing the medical study of the blood and blood-producing organs.
Immunology: the branch of medical science that studies the body's immune system.
Microbiology: the branch of biology that deals with microorganisms and their effects on other living organisms.
Neurology: the medical science that deals with the nervous system and disorders affecting it.
Obstetrics and Gynecology: Obstetrics is the branch of medicine that deals with the care of women during pregnancy, childbirth, and the recuperative period following delivery. Gynecology is the branch of medicine dealing with the administration of health care to women, especially the diagnosis and treatment of disorders affecting the female reproductive organs.
Ophthalmic: of or relating to the eye.
Orthopedics: the branch of medicine that deals with the prevention or correction of injuries or disorders of the skeletal system and associated muscles, joints, and ligaments.
Pathology: the scientific study of the nature of disease and its causes, processes, development, and consequences.
Physical Medicine: the branch of medicine that deals with the treatment, prevention, and diagnosis of disease by essentially physical means, including manipulation, massage, and exercise, often with mechanical devices, and the application of heat, cold, electricity, radiation, and water.
Radiology: the branch of medicine that deals with the use of radioactive substances in diagnosis and treatment of disease.
Toxicology: the study of the nature, effects, and detection of poisons and the treatment of poisoning.
Molecular Genetics: refers to devices that detect human DNA and RNA.
Subclasses
Subclasses are not used for medical device and in vitro diagnostic products. Although Subclass is not used in this Industry, users and filers still need to transmit a hyphen "-" on the subclass field. The Product Code Builder Application will return a dash automatically.
Process Indicator Codes (PIC)
PICs are not used for medical device and in vitro diagnostic products. Although Process Indicator Code is not used in this Industry, users and filers still need to transmit a hyphen "-" on the PIC field. The Product Code Builder Application will return a dash automatically.
Check Your Knowledge
Code the Products
Now you will have a chance to practice coding some medical device and in vitro diagnostic products. Below you will find eight product descriptions. Read the descriptions and then click on the PCB Application button below. This will take you to the PCB application.
Have paper and a pen or pencil handy. As you code each product, write down the product code result. When you're ready to check your answers, click the Tutorial button on the Taskbar. The Taskbar is located at the bottom of the screen. This will bring you back here. Caution: Don't click the Tutorial button in the Product Code Builder application; it will take you to the beginning of the Tutorial.
LATEX EXAMINATION GLOVES
General Hospital/ Personal Use
No particular meaning
Not used
Not used
Glove, Patient Examination, Latex
ULTRASONIC FETAL MONITOR
Obstetrical and Gynecological
No particular meaning
Not used
Not used
Monitor, Ultrasonic, Fetal
SUNGLASSES
Ophthalmic
No particular meaning
Not used
Not used
Sunglasses (non-prescription including photosensitive)
ANTIBIOTIC ASSAY CULTURE MEDIA
Microbiology
No particular meaning
Not used
Not used
Culture Media, Antibiotic Assay
SOFT CONTACT LENSES (EXTENDED WEAR)
Ophthalmic
No particular meaning
Not used
Not used
Lenses, Soft Contact, Extended Wear
CLINICAL ELECTRONIC THERMOMETER
General Hospital/Personal Use
No particular meaning
Not used
Not used
Thermometer, Electronic, Clinical
TYPHUS FEVER ANTISERUM
Microbiology
No particular meaning
Not used
Not used
Antiserum, Typhus Fever
FIRST AID KIT (with drug)
General and Plastic Surgery
No particular meaning
Not used
Not used
Kit, First Aid
Check your answers — Click on reveal code for each product description to reveal the correct product code. Compare it with the one you noted. Did you get the correct code? If not, determine which element was incorrect. You can go back to the Product Code Builder application and try again.