PCB Tutorial

Lesson 7 — Coding Medical Device, In Vitro Diagnostic and Non-Medical Radiation Emitting Products

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

1. The Process Indicator Code (PIC) for medical device and in vitro diagnostic products provides the following information:
2. The Subclass for medical device and in -vitro diagnostic products provides the following information:
3. Since the Subclass and Process Indicator Code components are not used for medical device and in vitro diagnostic products how should these fields be completed by filers:
4. Why is it easier to determine the product code for a medical device or in vitro diagnostic product by searching for a product name rather than sequentially building each component?

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.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English

Go to Top