4 Essential Steps to Identify The Regulatory Pathway for Your Medical Device

By Caroline

The regulatory landscape for medical devices is complex. From the very start of the development process, it’s essential to define the right regulatory strategy to prevent unexpected challenges when your device enters the market.

To help you identify the right regulatory pathway for your medical device, Caroline Lau, Quality Assurance Coordinator and Regulatory Requirements Expert, guides you through four key steps.

1

Is Your Product a Medical Device?

Before going any further, the first step is to determine whether your product is a medical device.

Determining the Product's Intended Use and Indications for Use

To do this, we need to take a closer look at the product’s intended use and indications for use. Intended use is the general purpose or function of the device, while indications for use refer to the disease or clinical condition that the device is intended to diagnose, treat, prevent, cure, or alleviate, as well as the patient population for which it is intended.

Referring to the Definition Given by Current Legislation

Once the intended use and indications for use have been identified, it is possible to verify whether the device is a medical device according to current legislation.

Health Canada defines the term in both the Medical Devices Regulations SOR 98/292 and the Food and Drugs Act. Its definition can be summarized as follows: “A medical device is any instrument or component used for the treatment, diagnosis or prevention of a disease or abnormal physical state”. It also specifies that medical devices do not include instruments used for veterinary purposes, or instruments using only pharmacological means.

In the United States, the definition is much the same, except that it includes instruments dedicated to animal care.

Case Study

Let’s take the example of an innovative product currently under development: a device for monitoring intracranial temperature and pressure.

Intended Use
The device provides information (temperature and intracranial pressure) to licensed clinicians to assist in the diagnosis of (fictitious) Pathocranial disease, in addition to the patient’s history, vital signs, and clinical information, so that the clinician can take it into account according to his or her own clinical judgment.
The device does not provide a diagnosis or treatment recommendations.

Indications for Use
For an adult population with Pathocranial disease.
By a licensed clinician.
In hospitals only.

To determine whether this is a medical device, here are the questions to ask:

– Is the product intended for the diagnosis, treatment, mitigation or prevention of a disease, disorder, or abnormal physical state, or its symptoms?
The answer is YES.

– Does the product use only pharmacological or chemical means?
The answer is NO.

– Is the product used on an animal?
The answer is NO.

Conclusion: The product is a medical device.

2

Identifying the Class of Your Medical Device

Once you’re certain that your product is a medical device, it’s time to identify the class to which it belongs. This will determine the regulatory pathway you need to follow to access the intended market.

Classification is based on the risk involved in using the medical device. The higher the risk, the higher the class. Note that classification rules vary by jurisdiction. For example, the same product may not be classified the same way in the United States as in Canada.

In Canada

In Canada, classification rules are defined in Appendix 1 of the Medical Devices Regulations (SOR/98-282).

Please review and evaluate these rules to determine if they apply to your product. Guidelines with specific examples are also available to help you interpret the rules.

In the USA

In the USA, the reference document is the Code of Federal Regulations (CFR) – Title 21.

There are three primary ways to identify the class of your product:

– Search the Product Classification Database.

– Search for similar products in the Establishment Registration and Device Listing Database.

– Search for similar products in the following registers: Premarket Approval (PMA), Premarket Notification 510(k), De Novo, and Humanitarian Device Exemption (HDE).

Case Study

Let’s take the above example, the intracranial temperature and pressure monitoring device, and identify its class.

In Canada

When reviewing Appendix I of the Medical Devices Regulations (SOR/98-282), you will notice that it is essential to carefully read the definitions in the regulations:

– We eliminate the applicability of rules 1 to 3, as our device is non-invasive.

– Rules 4 to 6 do not apply, as our device is not intended for the purposes identified.

– According to rule 7, we would be potentially classified as Class I by default.

– Our device is active because it uses an energy source (infrared for temperature), but it does not emit ionizing radiation (rule 8), is not therapeutically active (rule 9), and is not intended to administer substances (rule 11).

– It is an active diagnostic device (rule 10(1)), and an erroneous reading is not likely to present an immediate danger (rule 10(2)).

– The special rules (rules 13 to 16) do not apply to our device.

In conclusion, rule 7 indicates Class I, and rule 10(1) indicates Class II. The rule giving the higher classification should be adopted. Therefore, our device is classified as Class II, according to rule 10(1) of the regulations.

In the USA

A search for the keyword “thermometer” in the Product Classification database yields five (5) results of interest, all of which are Class 2.

The result most similar to our device is “Thermometer: Electronic Clinical”, which is Class 2.

We also search for the keyword “Intracranial pressure”, as this is the second main function of our device. We find three (3) results, two (2) of which are Class 2, and one (1) Class 3. One result reads “Intracranial Pressure & Temperature Monitoring Kit”, product code PSP, Class 2. Our device is potentially of this class.

To confirm that the product code is applicable, we’ll need to demonstrate that our device is substantially equivalent to a device already on the market bearing this product code.

Since our intended use targets a particular disease and the device presents data in a different way from technology already on the market, this code could be refused. We would then be without a product code with an indeterminate class.

3

Identifying Potential Regulatory Pathways

Now that you know which class your medical device belongs to, it’s time to choose the most appropriate regulatory pathway.

In Canada

There are two main ways of obtaining the necessary authorizations from Health Canada. Depending on the class to which your product, you can apply for a Medical Device Licence (Class II, III, and IV) or a Medical Device Establishment Licence (Class I).

The first option is more complex, as it requires the submission of a file for a full scientific and regulatory review, while the second only requires the filing of a form with the manufacturer’s declaration of regulatory compliance.

Two other pathways are also available for special cases: obtaining an Investigational Testing Authorization (for Class II, III, or IV products) or the Special Access Program (for Class III or IV products).

In the USA

To submit a file to the FDA in the United States, you have three options, depending on the class of your product:

– For a Class III device, you can apply for Premarket Approval (PMA). This involves submitting a file for a full scientific and regulatory review.

– For Class I, II, and III devices, you can obtain a 510(k) Premarket Notification by submitting a file demonstrating substantial equivalence to an approved device already on the market.

– For Class I and II devices, you can be exempted from Special Controls, in which case all you need to do is register the device and the establishment (i.e., the manufacturer) in the Establishment Registration & Device Listing.

Other pathways apply for special cases, such as De Novo for Class I and II products that have no substantial equivalence (i.e., they have no product code to identify with), and Humanitarian Device Exemption (HDE) for Class III products intended for rare diseases or conditions.

Case Study

Let’s take the example above, the intracranial pressure and temperature monitoring device, and identify the applicable regulatory pathways.

In Canada

We would submit a medical device licence application to the Ministry, following the applicable guidelines.

Prior to this, we would have obtained MDSAP/ISO 13485:2016 certification for our quality management system and ensure adequate documentation of the medical device to demonstrate its effectiveness and safety.

In the USA

If we identify the device as a Class II in the USA with the PSP product code, the regulatory path will probably be 510(k).

In this path, it is necessary to establish substantial equivalence with devices already on the market. It will be important to do our homework before submitting a file in this regard.

In the event that we are assigned an indeterminate class by the FDA, the De Novo pathway will most likely be the appropriate option.

In all cases, a dialogue must be established with the authorities to establish a win-win relationship for the advancement of the file. The FDA will confirm the applicable pathway.

Its decisions are based on risk, emphasizing the importance of effective risk management according to ISO 14971:2019 throughout the medical device’s lifecycle.

“Establishing a regulatory strategy early in the design and development of a medical device is crucial.”

Caroline Lau
Quality Assurance Coordinator at CLEIO

4

Identifying Required Documentation

Up to this point, we’ve been discussing the laws and regulations that every manufacturer must comply with to bring a medical device to market. In addition to these, there are standards that must be integrated during device design and development, or during manufacturing. These standards demonstrate the safety and efficacy of the medical device for its intended use and indications.

There are standards integrated into the quality management system process, such as ISO 13485 for the system itself, ISO 14971 for the risk management process, IEC 62304 for software development, and IEC 62366-1 for the usability process. There are also technical standards, such as IEC 60601-1 for electromedical devices, used to control technical risks associated with the device’s characteristics.

Cheat Sheet

Ultimate Cheat Sheet for Medical Device Standards

Keeping track of the main standards and regulations in medical device development can be challenging. That’s why we’ve created this indispensable cheat sheet.

Download

The application of recognized standards is voluntary, not compulsory. However, adherence to these internationally recognized methods facilitates the evaluation of applications for authorization to market medical devices. Simply refer to the lists of recognized standards in the guides and databases provided by each jurisdiction.

Case Study

Let’s take the example above, the intracranial pressure and temperature monitoring device. A good understanding of the device’s requirements and specifications, combined with an in-depth analysis, will enable you to identify all the applicable standards.

Below is an initial list of standards applicable to this device:

AAMI NS28 Intracranial pressure monitoring devices
ASTM E1104-98 Standard Specification for Clinical Thermometer Probe Covers and Sheaths
ASTM E1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
ASTM E1112-00 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-2-49 Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
IEC 80601-2-59 Medical electrical equipment – Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO IEEE 11073-10408 Health informatics – Point-of-care medical device communication – Part 10408: Device specialization – Thermometer
ISO 80369-6 Small bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications
ISO 80601-2-56 Medical electrical equipment – Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

In order to prepare your product’s arrival on the market, several parameters need to be considered from a regulatory point of view: its intended use and indications for use, its classification, potential regulatory pathways, as well as the activities and documentation required.

A thorough understanding of the rules of the game is essential for the successful registration of your medical device.