Understanding the Medical Device Classification and Approval Process – Part One

Many healthcare companies approach us when their company has an idea for a health product that might considered a medical device. For example, a client may inquire about manufacturing an electronic at-home fetal heart-rate monitoring product.

Some of the questions a client may have are:

• What type of research do I need to do before creating a company around the product.
• How would we approach FDA regulation for this?
• What would the device be classified as?
• Are existing classes device similar enough for the regulatory process to be easier?
• What would be needed to get FDA approval?

Among the many legal healthcare compliance issues we need to review is when and how the FDA classifies medical devices, what type of classification system, and what the criteria are for approval.

We’ve discussed some of the issues involved with medical device approval before. This article expands that conversation and focuses on the specific example of an electronic fetal heart-monitoring device – a type of mobile application.

Initial FDA medical device issues

Our review would discuss the following four issues:

1. Is the product a medical device as defined by the FDA?
2. How will the FDA classify the device?
   1. Whether a 510(k) is used to obtain FDA approval.
   2. Whether premarket approval (PMA) is used to obtain FDA approval
   3. Whether the product is exempt. The classification generally governs the FDA approval considerations as follows:
3. How is your device classified?
   1. Class I Devices. This type of medical device is typically exempt – Premarket Notification and FDA clearance are not required before marketing. In some cases, Class I devices may also be exempt from GMPs (Good Manufacturing Practices). Registration and Listing are required. “Premarket Notification means 510(k), unless exempt, or Premarket Approval (PMA).”
   2. Class II Devices. This type of medical device is normally exempt from premarketing notification, but not exempt from GMPs. Registration and Listing are required.
   3. Class III Devices. This type of medical device normally requires Premarket Approval.
4. We’ll review the following medical device issues too:
   1. Labeling requirements
   2. Medical device listing on Form FDA-2892
   3. Medical device reporting (MDR)
   4. Establishment registration on form FDA-2891
   5. Quality System (QS) regulation / GMPs
5. We’ll develop the necessary information to submit a 510(k) or PMA, including labeling if necessary.

It’s critical to know that mobile medical apps that function like medical devices will likely be treated as medical devices by the FDA – and thus are subject to medical device regulation.

510 (k) and Premarket Approval

A 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States:

• Before May 28, 1976, or
• To a device that has been determined by FDA to be substantially equivalent.

“Generally, medical products that require PMAs are Class III devices are high risk devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I and II predicate through the 510(k) process. The PMA process is more involved and includes the submission of clinical data to support claims made for the device. The PMA is an actual approval of the device by FDA.” 

The FDA states that premarket approval (PMA) is:

“The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing approval.”

What are some of the different types of medical devices

As we discussed, medical devices can range from simple products like tongue depressors and bedpans to complex devices with sophisticated technology. Medical devices include “in vitro diagnostic products such as general-purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology.” Our fetal heart-monitoring device might fit into the medical device definition because it’s an in vitro product.

What steps does the FDA use to regulate medical devices?

The FDA states that the FDA may regulate a product as a medical device by using the following two steps:

Step 1: Determine if your product meets the definition of a medical device – as set forth in Section 201(h) of the Food, Drug, and Cosmetic Act (FDCA). The FDCA defines a medical device as:

“An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

1. 1. Recognized in the official National Formulary [a US pharmaceutical publication], or the United States Pharmacopoeia, or any supplement to them
   2. Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
   3. Intended to affect the structure or any function of the body of man or other animals, and [other criteria]. The term “device” does not include software functions excluded pursuant to section 520(o).”

For starters, this means a product developer needs to understand the “intended use and indications” for the product.  Generally, if the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug.

The regulatory controls increase from Class I to Class III as described above.

Using our electronic fetal-monitoring device example, this product does, by its definition, seek to diagnose a medical condition (the fetus’ heartrate) and would likely be considered by the FDA as a medical device on that basis among others.

Step 2: Determine if an appropriate product classification exists for your product

The FDA recommends that developers and manufacturers search for existing product classifications that may apply to their product. A comparable match indicates your device will be considered a medical device. There are different ways to conduct this search. Skilled healthcare lawyers will help you if you have questions.

Method 1: Search the FDA Product Classification Database to determine if there is an existing product classification that applies to your product. You can use keywords to conduct a quick search or the advanced search method to conduct a search by product code, regulation number, or device class.

Using our example, typing in the words “fetal heart monitor” yields these results:

HEQ	Monitor, Pressure, Arterial, Fetal, Ultrasonic	Fetal Ultrasonic Monitor And Accessories…	884.2660
HFP	Monitor, Phonocardiographic, Fetal	Fetal Phonocardiographic Monitor And Acc…	884.2640
KNG	Monitor, Ultrasonic, Fetal	Fetal Ultrasonic Monitor And Accessories…	884.2660
KXN	Monitor, Cardiac, Fetal	Fetal Cardiac Monitor	884.2600

All these devices are categorized as Class 2 medical devices.

Method 2: Search for Similar Devices. FDA states that “If you identify a similar device legally marketed in the United States, you may search for an FDA letter or order that permits market authorization. The information in the letter or order for a similar device type might help you determine the classification of your device. “

Other databases that can be used to review permit marketing authorization include:

Premarket Approval (PMA) – Most Class III (high risk) devices require Premarket Approval (PMA) before the devices may be legally marketed. This database includes devices with Premarket Approval, and includes the approval order, Summary of Safety and Effectiveness, and labeling for the approved device (original PMAs and panel-track supplements).

In our example – searching for “fetal heart monitor”, the following results appear:

Stan S31 Fetal Heart Monitor	NEOVENTA MEDICAL AB	P020001 S009	11/18/2011
Neoventa’s Stan S31 Fetal Heart Monitor	NEOVENTA MEDICAL AB	P020001 S008	08/04/2011
Neoventa’s Stan S31 Fetal Heart Monitor	NEOVENTA MEDICAL AB	P020001 S006	11/16/2009
Neoventa’s Stan S31 Fetal Heart Monitor	NEOVENTA MEDICAL AB	P020001 S004	04/11/2008
Stan S31 Fetal Heart Monitor	NEOVENTA MEDICAL AB	P020001 S005	03/12/2008
Stan S31 Fetal Heart Monitor	NEOVENTA MEDICAL AB	P020001 S002	09/26/2007
Stan S31 Fetal Heart Monitor	NEOVENTA MEDICAL AB	P020001 S001	07/03/2007
Stan S31 Fetal Heart Monitor	NEOVENTA MEDICAL AB	P020001	11/01/2005

Premarket Notification 510(k) – Most Class II (moderate risk) devices require 510(k) clearance from the FDA before the devices may be legally marketed. This database includes releasable 510(k) information.

Searching for Nuvo (based on the article – mention it).  The 510 (k) approval of Pregsense is discussed in part two of this topic.

Invu By Nuvo	Nuvo- Group Ltd.	K221046	05/06/2022
Invu By Nuvo	Nuvo-Group Ltd.	K210025	05/28/2021
Pregsense	Nuvo-Group Ltd.	K191401	03/27/2020

• De Novo – De Novo provides a possible route to classify novel devices of low to moderate risk. This database includes De Novo classification orders and transparency summaries.
• Humanitarian Device Exemption (HDE) provides a possible route to market medical devices that may help people with a rare diseases or conditions.

Note: Most Class I and some Class II devices may not be listed in the databases referenced above because they are exempt and do not require the FDA’s review before marketing.

Method 3: Search for Similar Devices by Device Listing

The FDA states that “Device listing information can be found by searching the FDA’s Establishment Registration and Device Listing database, using either the Quick or Advanced Search feature.”

Generally, manufacturers and many other participants in the manufacture and distributors of the devices must list their devices with the FDA.

There are many compliance issues that must be discussed when developers and manufacturers want to market healthcare products. Is the product a medical device? If so, what is the class category of the device? Does the device require 510 (k) approval or premarket authorization? What other controls and compliance issues apply? Is your device substantially equivalent to another FDA approved device?

Developers and manufacturers of medical devices should contact Cohen Healthcare Law Group, PC to discuss FDA oversight, 510(k) approval, and other compliance issues. Our experienced healthcare attorneys advise medical companies and the doctors who prescribe medical devices about healthcare compliance laws and regulations.