Last Updated on January 20, 2024 by BIOMEDRIC

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services, which is responsible for regulating food and medical products that are manufactured, imported, or marketed in the U.S. The FDA’s primary purpose is to ensure that these items are safe and effective since public health falls under this branch of government’s jurisdiction. The FDA Regulations for in-vitro diagnostic medical devices are part of this goal of the FDA.

In-vitro diagnostic (IVD) medical devices are reagents, instruments, and systems designed for the collection, preparation, and examination of specimens such as blood and saliva from the human body for the determination of the state of health.

As in other medical devices, IVD medical devices are subject to a different set of regulations, referred to as the “premarket requirements” (all of the measures prior to introducing a device into U.S. commerce) and “postmarket requirements” (all of the measures after introducing a device into U.S. commerce); and the regulations are risk-based.

Premarket Requirements

Medical devices, including IVD medical devices, are classified by the FDA into three classes, Class I (low-risk), Class II (moderate-risk), and Class III (high-risk) on the basis of their health risk. While many low-risk Class I devices are exempt from premarket review, the premarket review is required for moderate-risk Class II and high-risk Class III devices.

There are two main routes for the premarket review process, one of which is generally for new and high-risk devices and involves conducting clinical trials and submitting a premarket approval (PMA) application. The other route includes submitting a 510(k)-notification that the device in question is equivalent to an already commercially available predicate device that does not require a PMA; clinical data are usually not required for this route.

For an IVD medical device to be successful in either pathway, it must demonstrate safety and efficacy through analytical validation (an indicator of how well a test detects or measures a biomarker in a sample) and clinical validation (an indicator of how well a test can yield results pertaining to a particular medical condition or physiological/pathological state).

Before a clinical study is initiated, generally, an investigational device exemption (IDE) allows an unapproved (via PMA) or uncleared (via 510(k)) investigational device to be used in a clinical study for data collection to support a premarket submission.

Postmarket Requirements

Manufacturers and distributors must follow postmarket requirements to ensure that IVD medical devices continue to meet the same standards as when they were first introduced; the requirements typically include:

Manufacturing: The device’s manufacturing procedures must comply with Current Good Manufacturing Practices (cGMP) outlined by Quality System (QS) regulation.

Labeling: All FDA approved or cleared medical devices are required to have appropriate labeling that contains descriptive and informative literature to inform a user of how to use the device. 

Tracking: For Class II and Class III devices that meet certain criteria set by the FDA, the FDA demands a device tracking system; device tracking ensures that manufacturers can quickly locate a particular device posing health risks. 

Adverse Event Reporting: Medical Device Reporting (MDR) is one of the post-marketing tools used by the FDA, which includes reporting of adverse events resulting from the use or misuse of medical devices by manufacturers, device user facilities, and importers.

Postmarket Surveillance: Postmarket surveillance studies are required for high-risk Class II and Class III medical devices that meet certain criteria set by the FDA to proactively collect and review experience regarding the marketed devices. 

An Overview of Class-Based FDA Regulations 

• Class I IVD Medical Devices: These devices are in the lowest-risk category exempt from premarket review; general controls containing registration, listing, labeling, good manufacturing practices, and 510(k) clearance are sufficient for Class I IVD medical devices.  
• Class II IVD Medical Devices: These devices are in the moderate-risk category where special controls beyond the general controls are required; special controls contain special labeling requirements, performance standards, and postmarket surveillance.
• Class III IVD Medical Devices: These devices are in the high-risk category subject to PMA requirements for which general and special controls are not sufficient; the PMA process is a comprehensive and stringent process, which typically requires valid scientific evidence and clinical studies.

BIOMEDRIC Support for IVD Medical Device Manufacturers

BIOMEDRIC specializes in providing high-end support for all sorts of in-vitro diagnostic medical devices regarding preclinical stage, clinical stage, and post-clinical stage. Whether you want to get FDA approval for in-vitro diagnostic medical devices or want our consultancy services for in-vitro diagnostic medical devices, our specialists would love to know about your requirements for safe practices in the industry.

Not only this, but BIOMEDRIC also gives extensive briefings related to all aspects of medical devices including in-vitro diagnostic medical devices, their types, usage, and the laws. The interface also promotes a user-friendly outlook to assessing the needs and use of the company, with due diligence to the regulations of the FDA.

Please contact us ([email protected] or [email protected]) for the high-quality scientific/technical/regulatory consultancy, reporting, and filing services you may need regarding the FDA regulations for in-vitro diagnostic medical devices.