Understanding the Medical Device Classification and Approval Process – Part Two

This article is the second part of our discussion of medical devices. In particular, the article is part two of our discussion of fetal heart monitors as medical devices.

How are the different classes of medical devices defined?

According to the FDA, medical devices are classified as a Class I, II, or III device (with or without exemptions) depending on the “intended use of the device and also upon indications for use.”

An example of intended use for a scalpel is to use the scalpel to cut tissue. More specialized scalpels may have the intended use of making cornea incisions. Generally, the indications are found in the device’s labelling – which makes it important to review with an experienced legal healthcare lawyer what the label says and what the label is required to say.

Classification is also based on risk. Generally, Class III medical devises have the greatest risk while Class I medical devices have the lowest risk.

“All classes of devices are subject to General Controls. General Controls are the baseline requirements of the Food, Drug and Cosmetic (FD&C) Act that apply to all medical devices, Class I, II, and III.”

As we’ve discussed previously, you can determine what class your medical device is by reviewing the classification database and searching for a part of the device name. Or, “if you know the device panel (medical specialty) to which your device belongs, go directly to the listing for that panel and identify your device and the corresponding regulation.”

Our experienced health care lawyers will review if your device, such an electronic fetal heartrate monitor:

• Is a medical device
• The classification of the medical device
• The FDA approval requirements including 510 (k) approval and or premarket approval

What are classification panels?

FDA has classified and described over 1,700 distinct types of devices and organized the devices in the CFR into 16 medical specialty “panels” such as Cardiovascular devices or Ear, Nose, and Throat devices.

“For each of the devices classified by the FDA the CFR gives a general description including the intended use, the class to which the device belongs (i.e., Class I, II, or III), and information about marketing requirements.”

For example, information about obstetrical and gynecological devices can be found here. If your device requires premarket notification [510(k)], you and your healthcare lawyer need to proceed to the Premarket Notification [510(k)] page.

“Most Class I and Class II devices are exempt from premarket notification [510(k)] requirements. They may also be exempt from the current Device Good Manufacturing Practices (GMP), requirements under the Quality System (QS) Regulation.”

“A class I or class II device that is exempt from 510(k) requirements must still comply with other requirements (known as regulatory controls) unless the device is expressly exempt from those requirements as indicated in the regulation for that device type.”

“A class I device is not exempt from 510(k) notification requirements if it is intended for a use of substantial importance in preventing impairment of health, or presents a potential unreasonable risk of illness or injury.”

“A listing of class I and class II devices exempt from 510(k) requirements is available on the Medical Device Exemptions 510(k) and GMP Requirements website. Exemptions to the premarket notification requirements of 510(k) apply only to those devices that have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type.”

A list of exempt obstetrical and gynecological medical devices can be found here.

510 (k), Premarket Approval, and exemptions for medical devices

“According to the FDA, a manufacturer who intends to market in the United States a Class I, II, or III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit to FDA a premarket notification submission (often referred to as a 510(k)), unless the device is exempt from the 510(k) requirements of the FD&C Act and does not exceed the limitations of exemptions for each of the device classification regulations (Section .9 of 21 CFR Parts 862 through 892, e.g., 21 CFR 862.9, 21 CFR 864.9, etc.).”

“Under section 510(k) of the FD&C Act, a manufacturer must submit a 510(k) to FDA at least 90 days before introducing, or delivering for introduction, a device into interstate commerce for commercial distribution.”

The FDA will review whether the medical device is “substantially equivalent (SE) to a legally marketed (predicate) device.” The FDA must issue a 510 (k) clearance that the device is SE before the device can be “commercialized.”

The FDA has guidance on a variety of issues that must be addressed such as:

• The appropriate use of multiple predicates.
• The processes associated with determining whether a new device with new indications for use has a new intended use.
• The process for determining whether different technological characteristics raise different questions of safety and effectiveness.
• Many other issues.

“The most commonly used method of demonstrating substantial equivalence is through the submission and FDA review and clearance of a Traditional 510(k).”

“The 510(k) review standard (substantial equivalence of a new device to a legally marketed (predicate) device) differs from the PMA review standard (reasonable assurance of safety and effectiveness).” “The 510(k) review standard is comparative, whereas the PMA standard relies on an independent demonstration of safety and effectiveness.”

A recently approved fetal heart monitor device

In March 2020, MedCity News reported that Nuvo Group (a medical device based in Tel Aviv) received 510(k) clearance from the Food and Drug Administration for its wearable sensor band, which can monitor fetal and maternal heart rate data. Doctors will now be able to prescribe a sensor band that women in the third trimester of a pregnancy can wear on their abdomen. The FDA approved the device for women who are in or beyond their 32nd gestation week. The FDA found that the device was “was sufficiently accurate and easy to use.” The device will help mothers monitor their child’s heart rate from a distance – from their physician.

“Nuvo had to design and build a platform that combines proprietary/unique hardware and software together with advanced signal processing and machine learning algorithms to overcome these challenges.”

The 510 (k) summary states that:

“PregSense™ is a non-invasive medical device that acquires and displays vital signs of the pregnant woman and of her fetus. It measures and processes signals picked up on the abdominal surface using sensors, electronic circuitry and processing software.”

Indications for Use PregSense. The 510(k) summary also states, among other findings, that PregSense is:

• “A maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR) and maternal heart rate (MHR).
• The PregSense maternal-fetal monitor is intended for use in the antepartum period by healthcare professionals in health care facilities and by the patient in the patient’s home, on the order of a physician.
• The PregSense is not intended for use in critical care situations or in laboring patients or those patients hospitalized for or suspected to have preterm labor.”

The 510 (k) summary use a substantial equivalence (SE) review of another medical device, Sense4Baby System Model B+, to support its opinion. Both products were found to have the same intended use though their indications for use are different. The summary also includes non-clinical performance data and clinical performance data.

The FDA found that “The results of the performance testing described above demonstrate that the PregSense device is as safe and effective as the predicate device and supports a determination of substantial equivalence.”

Developers and manufacturers of healthcare products need to understand how the FDA regulates those devices. If the FDA considers your products as a medical device, the agency will classify your device as a Class I, II, or III device. The classification and other factors such as classify classification panels that determine what type of FDA approval is required for your product. Showing that your product is substantially equivalent to another medical device that has received FDA approval can help your product receive 510 (k) approval.

The developers and makers of medical devices should contact Cohen Healthcare Law Group, PC to discuss FDA’s medical device rules. Our experienced healthcare attorneys advise medical companies and the doctors who prescribe medical devices about healthcare compliance laws and regulations.