Medical Device Reporting, Complaints, and Corrections & Removals Reporting: Laboratory Developed Tests FAQs
A: The definition of “a finished device” under 21 CFR 820.3(l) is any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.
A: As stated in the preamble to the Final LDT Rule, FDA’s regulations define manufacturing to include a variety of activities, including design, preparation, propagation, assembly, and processing. Under the regulations, a manufacturer may include “any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedures,” or “any person who designs, manufactures, fabricates, assembles, or processes a finished device.” Manufacturing includes but is not limited to the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development.
If a laboratory manufactures a test system, it is a manufacturer, even if it does not manufacture the components of that system (such as instruments, software, and reagents). Laboratories do this by sourcing individual components and combining them to assemble a single test system with a specific intended use. For example, a laboratory that develops a PCR-based, targeted genetic test for Factor V Leiden thrombophilia must source or manufacture primers and probes and validate a PCR instrument to assemble their test. These primers, probes and instrument together, along with other components, comprise a test system with a specific intended use that is independent of each individual component’s intended use. Similarly, when a laboratory develops a test for measurement of hormone levels using mass spectrometry, they must source or manufacture calibrators and qualify a mass spectrometry instrument in order to perform that test.
A: Recalls are actions taken by a manufacturer to remove or correct a marketed device that FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action.
- A removal is the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.
- A correction is the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location.
Therefore, an action may constitute a recall whether or not the device is physically removed. Even if materials and equipment never leave a lab, they can be recalled.
A: “Commercial distribution” means “on the market”. Commercial distribution does not require the physical transfer of an object, nor does it require transfer of title. Because LDTs generally are “on the market”, they are for commercial distribution. For example, like manufacturers of other IVDs do, laboratories often promote their LDTs on their websites and hold or offer them for sale.
Even if a medical product never leaves a physician’s office, medical products that are used in the diagnosis or treatment of patients even where the product itself is not delivered or transferred to a patient are considered to be “commercially distributed”. Therefore, a test that is manufactured and performed in a laboratory is considered to be “commercially distributed”.
A: The Quality System Record (QSR) must include, or refer to the location of, procedures and the documentation of activities required under Subpart M that are not specific to a particular type of device, such as the requirement to ‘establish and maintain procedures for receiving, reviewing, and evaluating complaints’ under 21 CFR 820.198. As discussed in the final rule, for these categories of IVDs, FDA does not generally expect compliance with §§ 820.20, 820.22, 820.40, and 820.50.
A: According to CMS’s CLIA Complaints Booklet, CLIA complaint handling requirements relate to an individual laboratory's operations, such as specimen handling errors, quality of testing, laboratory personnel qualification issues, and record falsification. FDA's complaint handling requirements focus on investigating and identifying test-specific problems, such as problems related to design, manufacturing, and components. An investigation into a complaint may reveal that the root cause is related to laboratory operations or to the test itself, and the corrective actions may differ based on these findings. To address test-related complaint handling requirements outlined in 21 CFR 820.198, a laboratory may decide to expand its current complaint handling procedures, which meet CLIA requirements. All test-related complaints that a laboratory receives are required to be evaluated for medical device reporting (MDR) through FDA's MDR system, which allows for broader public health surveillance across the laboratory ecosystem.
A: When a laboratory modifies another manufacturer’s cleared or approved test, they are the manufacturer of the new test and must comply with applicable regulatory requirements, including medical device reporting. For example, this may be the case when a laboratory includes a modified kit from another manufacturer on their test menu.