A Guide to Navigating FDA Device Risk Classifications for New Products

This article breaks down the United States Food and Drug Administration (FDA) risk classification scheme for medical devices. Our team also provides insight on how best to think about risk in your product strategy.

Congrats! You're probably reading this because you've decided to build digital health or medical products and need clarity on how the FDA will view it. 

Can you simply start manufacturing, set up an e-commerce store and start selling?

Not quite. First, you'll need to make sure the device you’re trying to commercialize adheres to all of the controls for its risk classification that are required to protect consumers.

In working with startups, it has been our experience that identifying a classification early optimizes the product development process. Understanding how the FDA categorizes different types of medical devices and the approval process required for your device can help you navigate your path to market. A higher risk classification can drive more valuable claims for the intended use. Committing early to the appropriate controls can save costly remediation of both documentation and the product’s design prior to the commercialization.

The FDA medical device classification system

The FDA categorizes medical devices based on how much harm they may cause and how much regulatory control they require to keep the public safe. Class I devices generally pose the lowest risk to the patient and/or user; Class II devices have more risk potential compared to Class I, and Class III devices pose the highest risk.

Device classification is partly inherent based on the technology and intended use of the product, and it is also partly strategic. Many early stage companies elect to position their product in a lower-regulated Classification code such as Class I Exempt or Class II Exempt (which do not require 510k pre-market notification submissions) to place the product on the market, generate revenue, and gain use experience; this isn’t always an option, and it necessitates limiting the scope of the intended use and indications for use of the product which necessarily reduce the risk of harm during its use. Alternatively, targeting the higher Classification can help to impede competitors from introducing similar products; however higher Classifications require more controls, testing, submissions, and in many cases pre-clinical and/or clinical data. Having a clear approach to product classification is one of the first steps to bringing it to market, and this defines the requirements of both your Quality Management System (QMS) and the regulatory submission, if any, necessary to obtain pre-market clearance. Your QMS compliance practices and organization will play a significant role in bringing your device to market and keeping it on the market. FDA guidance: “Classify Your Device”

 

Medical device classifications are essential because regulatory controls prevent a device from going to market that hasn't been adequately tested for safety and efficacy. Even the lowest risk devices require site registration and device listing with the FDA, and they are subject to most general controls to prevent them from being improperly advertised, misbranded, mislabeled, or manufactured unsafely. 

Class I - Low-risk medical devices

Around 47 percent of medical devices on the market are Class I devices. They are the easiest and fastest to bring to market, and most of them are exempt from FDA requirements that demand premarket notification and approval. These medical devices are only obligated to meet the requirements for general controls.

Class I devices are required to comply with the fewest regulatory requirements, and typically:

  • Have minimal contact with patients
  • Won’t come into contact with internal organs, the central nervous system, the cardiovascular system, or intravenous/circulating blood.
  • Do not significantly impact a patient's overall health

The chances of a patient being put at risk by a Class I device is minimal.

Examples of Class I medical devices include items such as:

  • Oxygen masks
  • Tongue depressors
  • Bandages
  • Reusable surgical scalpels (for primary incisions only)
  • Hospital beds

A Class I device isn’t designed or intended to support or sustain life and doesn't play a significant role in preventing a patient’s health impairment. There’s no unreasonable risk of illness or injury. 

Class II - Devices subject to special controls

The next biggest class of medical devices are Class II devices, representing 43 percent of medical devices on the market.

These are more complex than Class I devices and present a higher category of risk because they can include devices that:

  • Can come in contact with a patient’s cardiovascular system
  • Can come in contact with internal organs
  • Serve as diagnostic tools

Class II devices must be proven safe since they can pose a hazard to a patient’s health or life. Examples of Class II medical devices include:

  • Blood pressure cuffs
  • Surgical gloves
  • Pregnancy test kits
  • Syringes
  • Blood transfusion kits
  • Catheters
  • Dissolving sutures

A Class II device is viewed as being one for which general controls are not sufficient to provide assurances about its safety and efficacy. 

Many Class II devices are subject both to general controls and special controls depending on device type, which can include special labeling requirements, patient registries, and performance standards. (Some Class II devices are Exempt from the 510(k) process, and if your device is among those on the exempted list, you may only have to comply with general controls.)

Most Class II devices are cleared by FDA for placement on the market through the Premarket Notification (PMN), or 510(k) submission process. The 510(k) process is designed to show that the new device is similar enough to a safe device already on the market that it can also be presumed as safe.

Class III - Devices require Premarket Approval (PMA)

Only around 10% of all medical devices fall into Class III, the most rigorous FDA device classification. These devices present a potentially high risk of illness or injury and must pass stricter standards for safety and efficacy before receiving authorization  to be placed on the market.

Class III devices may include but are not limited to devices which:

  • Are expected to help support life
  • Are expected to sustain life
  • Maybe implantable

Subject to the most restrictive sets of controls, Class III devices are required to prove their safety and efficacy. Examples of Class III medical devices include items such as:

  • Defibrillators
  • Pacemakers
  • High-frequency ventilators
  • Implanted prosthetics
  • Breast implants

Class III devices typically only can be brought to market after being subjected to general controls and the FDA Premarket Approval (PMA) process. Some Class III devices may be exempt from PMA and qualify for the 510(k) submission, however most are expected to go through the PMA process, which can include clinical trials.‍

Software as Medical Device (SaMD)‍

 

SaMD is an evolving category whose initial guidance was released December of 2017 and titled Software as a Medical Device (SAMD): Clinical Evaluation Guidance for Industry and Food and Drug Administration Staff . The FDA is working on a Pre-Cert program, which currently still requires the 510(k) risk classification process to be completed in parallel. This is largely because a change to the submission process requires changes to Federal Law via an Act of Congress.

 

The program currently focuses more on the qualification and competence of the company rather than the audit and clearance of a specific product or product version; it can be a good way to position yourself as a leader in the field. If you have a fantastic new medical software idea, it can be well worth it to join the dialog and be part of shaping the upcoming legislation around SaMD solutions. 

Introducing Enzyme

 

Are you excited about getting your medical device to market but are concerned by what you've just learned about how much work it can take?

 

Enzyme offers a cloud-based quality management and regulatory submission platform, as well as consulting services, to help you gather the data you need about your device and streamline the application process to get your product to market.

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A Guide to Navigating FDA Device Risk Classifications for New Products

This article breaks down the United States Food and Drug Administration (FDA) risk classification scheme for medical devices. Our team also provides insight on how best to think about risk in your product strategy.

Congrats! You're probably reading this because you've decided to build digital health or medical products and need clarity on how the FDA will view it. 

Can you simply start manufacturing, set up an e-commerce store and start selling?

Not quite. First, you'll need to make sure the device you’re trying to commercialize adheres to all of the controls for its risk classification that are required to protect consumers.

In working with startups, it has been our experience that identifying a classification early optimizes the product development process. Understanding how the FDA categorizes different types of medical devices and the approval process required for your device can help you navigate your path to market. A higher risk classification can drive more valuable claims for the intended use. Committing early to the appropriate controls can save costly remediation of both documentation and the product’s design prior to the commercialization.

The FDA medical device classification system

The FDA categorizes medical devices based on how much harm they may cause and how much regulatory control they require to keep the public safe. Class I devices generally pose the lowest risk to the patient and/or user; Class II devices have more risk potential compared to Class I, and Class III devices pose the highest risk.

Device classification is partly inherent based on the technology and intended use of the product, and it is also partly strategic. Many early stage companies elect to position their product in a lower-regulated Classification code such as Class I Exempt or Class II Exempt (which do not require 510k pre-market notification submissions) to place the product on the market, generate revenue, and gain use experience; this isn’t always an option, and it necessitates limiting the scope of the intended use and indications for use of the product which necessarily reduce the risk of harm during its use. Alternatively, targeting the higher Classification can help to impede competitors from introducing similar products; however higher Classifications require more controls, testing, submissions, and in many cases pre-clinical and/or clinical data. Having a clear approach to product classification is one of the first steps to bringing it to market, and this defines the requirements of both your Quality Management System (QMS) and the regulatory submission, if any, necessary to obtain pre-market clearance. Your QMS compliance practices and organization will play a significant role in bringing your device to market and keeping it on the market. FDA guidance: “Classify Your Device”

 

Medical device classifications are essential because regulatory controls prevent a device from going to market that hasn't been adequately tested for safety and efficacy. Even the lowest risk devices require site registration and device listing with the FDA, and they are subject to most general controls to prevent them from being improperly advertised, misbranded, mislabeled, or manufactured unsafely. 

Class I - Low-risk medical devices

Around 47 percent of medical devices on the market are Class I devices. They are the easiest and fastest to bring to market, and most of them are exempt from FDA requirements that demand premarket notification and approval. These medical devices are only obligated to meet the requirements for general controls.

Class I devices are required to comply with the fewest regulatory requirements, and typically:

  • Have minimal contact with patients
  • Won’t come into contact with internal organs, the central nervous system, the cardiovascular system, or intravenous/circulating blood.
  • Do not significantly impact a patient's overall health

The chances of a patient being put at risk by a Class I device is minimal.

Examples of Class I medical devices include items such as:

  • Oxygen masks
  • Tongue depressors
  • Bandages
  • Reusable surgical scalpels (for primary incisions only)
  • Hospital beds

A Class I device isn’t designed or intended to support or sustain life and doesn't play a significant role in preventing a patient’s health impairment. There’s no unreasonable risk of illness or injury. 

Class II - Devices subject to special controls

The next biggest class of medical devices are Class II devices, representing 43 percent of medical devices on the market.

These are more complex than Class I devices and present a higher category of risk because they can include devices that:

  • Can come in contact with a patient’s cardiovascular system
  • Can come in contact with internal organs
  • Serve as diagnostic tools

Class II devices must be proven safe since they can pose a hazard to a patient’s health or life. Examples of Class II medical devices include:

  • Blood pressure cuffs
  • Surgical gloves
  • Pregnancy test kits
  • Syringes
  • Blood transfusion kits
  • Catheters
  • Dissolving sutures

A Class II device is viewed as being one for which general controls are not sufficient to provide assurances about its safety and efficacy. 

Many Class II devices are subject both to general controls and special controls depending on device type, which can include special labeling requirements, patient registries, and performance standards. (Some Class II devices are Exempt from the 510(k) process, and if your device is among those on the exempted list, you may only have to comply with general controls.)

Most Class II devices are cleared by FDA for placement on the market through the Premarket Notification (PMN), or 510(k) submission process. The 510(k) process is designed to show that the new device is similar enough to a safe device already on the market that it can also be presumed as safe.

Class III - Devices require Premarket Approval (PMA)

Only around 10% of all medical devices fall into Class III, the most rigorous FDA device classification. These devices present a potentially high risk of illness or injury and must pass stricter standards for safety and efficacy before receiving authorization  to be placed on the market.

Class III devices may include but are not limited to devices which:

  • Are expected to help support life
  • Are expected to sustain life
  • Maybe implantable

Subject to the most restrictive sets of controls, Class III devices are required to prove their safety and efficacy. Examples of Class III medical devices include items such as:

  • Defibrillators
  • Pacemakers
  • High-frequency ventilators
  • Implanted prosthetics
  • Breast implants

Class III devices typically only can be brought to market after being subjected to general controls and the FDA Premarket Approval (PMA) process. Some Class III devices may be exempt from PMA and qualify for the 510(k) submission, however most are expected to go through the PMA process, which can include clinical trials.‍

Software as Medical Device (SaMD)‍

 

SaMD is an evolving category whose initial guidance was released December of 2017 and titled Software as a Medical Device (SAMD): Clinical Evaluation Guidance for Industry and Food and Drug Administration Staff . The FDA is working on a Pre-Cert program, which currently still requires the 510(k) risk classification process to be completed in parallel. This is largely because a change to the submission process requires changes to Federal Law via an Act of Congress.

 

The program currently focuses more on the qualification and competence of the company rather than the audit and clearance of a specific product or product version; it can be a good way to position yourself as a leader in the field. If you have a fantastic new medical software idea, it can be well worth it to join the dialog and be part of shaping the upcoming legislation around SaMD solutions. 

Introducing Enzyme

 

Are you excited about getting your medical device to market but are concerned by what you've just learned about how much work it can take?

 

Enzyme offers a cloud-based quality management and regulatory submission platform, as well as consulting services, to help you gather the data you need about your device and streamline the application process to get your product to market.

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