How are home health kits regulated under FDA and state law?

If you’ve designed a home health kit to test for, say, pregnancy or HIV, can you go ahead and market the product without FDA clearance or state law authorization? FDA regulates some health test kits as over-the-counter tests.

FDA suggests reviewing the In Vitro Diagnostics (IVD) Over the Counter (OTC) database to check whether it includes the test you plan to market.

Types of IVDs

In vitro diagnostics are tests that can detect diseases, conditions, or infections. Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home. This can include, for example:

• laboratory developed tests
• companion diagnostics
• drug abuse tests
• blood glucose monitoring devices
• home use tests
• lab tests

A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. LDTs can be used to measure or detect a wide variety of analytes (substances such as proteins, chemical compounds like glucose or cholesterol, or DNA), in a sample taken from a human body.

FDA states: “LDT’s are important to the continued development of personalized medicine, but it is important that in vitro diagnostics are accurate so that patients and health care providers do not seek unnecessary treatments, delay needed treatments, or become exposed to inappropriate therapies.

The FDA has generally not enforced premarket review and other applicable FDA requirements because LDTs were relatively simple lab tests and generally available on a limited basis.”

However, as LDTs have become more complex, FDA has “identified problems with several high-risk LDTs including: claims that are not adequately supported with evidence; lack of appropriate controls yielding erroneous results; and falsification of data. The FDA is concerned that people could initiate unnecessary treatment or delay or forego treatment altogether for a health condition, which could result in illness or death. The FDA is aware of faulty LDTs that could have led to: patients being over- or undertreated for heart disease; cancer patients being exposed to inappropriate therapies or not getting effective therapies; incorrect diagnosis of autism; unnecessary antibiotic treatments; and exposure to unnecessary, harmful treatments for certain diseases such as Lyme disease.” Accordingly, FDA has issued a guidance document.

A companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a health care professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potential serious side effects or risks.

A blood glucose monitoring device is a test system for use at home to measure the amount of sugar (glucose) in your blood. FDA recently used the de novo classification process (a regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device), to review a mobile medical app (MMA), that allows people with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using an Apple mobile device such as an iPhone. FDA did not require premarket clearance, because data provided by the device maker showed the device functions as intended and transmits data accurately and securely.

Home use tests include:

• cholesterol
• Hepatitis C
• HIV
• menopause
• fecal occult blood
• ovulation (saliva test)
• ovulation (urine test)
• pregnancy
• pothrombin
• vaginal PH

For example, a pregnancy home use test is a home-use test kit to measure human chorionic gonadotropin (hCG) in your urine; hCG is produced during pregnancy in the placenta. See 21 CFR 862.1155 (HCG test system).

There are many different kinds of medical devices and health tests. For example, clinical chemistry and toxicology devices (21 CFR Part 862).

IVD Classification

In FDA’s Overview of IVD Regulation, FDA provides a roadmap to the regulatory pathway of an IVD through FDA. The long version is that:

In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. 21 CFR 809.3

IVDs are medical devices as defined in section 210(h) of the Federal Food, Drug, and Cosmetic Act, and may also be biological products subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to premarket and postmarket controls. IVDs are also subject to the Clinical Laboratory Improvement Amendments (CLIA ’88) of 1988.

IVDs can be Class 1, Class 2 or Class 3, depending on risk classification.

As medical devices, IVDs are subject to:

• 510(k) submission for device clearance (unless exempt)
• establishment registration and device listing
• good manufacturing practices (GMPs) and quality system regulation (QSR)
• medical device reporting
• IVD labeling

When manufacturers ignore the fact that FDA may regulate their home use test kit, they can be subject to FDA enforcement. For example, FDA wrote a warning letter to Identigene concerning its home-use, urine collection, STD test, intended to diagnose chlamydia and gonorrhea infection. FDA noted that the manufacturer lacked FDA clearance for the device, and therefore could not market it.

CLIA Requirements

The federal Clinical Laboratory Improvement Amendments Act (CLIA) governs diagnostic testing for diseases and conditions. CLIA requires that clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct.

With regard to CLIA, three federal agencies are involved: FDA, CMS and CDC. FDA categorizes tests based on complexity, reviews requests for CLIA waivers, and develops rules/guidance for complexity categorization. CMS issues laboratory certificates, collects user fees, conducts inspections and enforces regulatory compliance, and does some other tasks; CDC’s role includes developing technical standards. (More at 42 CFR 493).

State law may also impose licensing requirements on clinical laboratories, and rules governing home testing for clinical conditions.

Contact our FDA attorneys if you have questions about your home health test kit.