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Medical Device Pathway to FDA Approval

Jun 22 2022

Step 1

Device Discovery and Concept

Medical device development follows a well-established path. Many of these steps overlap with each other as scientists invent, refine, and test the devices.

It is important to understand how devices are classified since the development process differs depending on the device's classification.


FDA classifies medical devices based on the risk posed by a device. Medical devices can change classification systems depending on the results of scientific data.

Class I : General Controls

  • Good manufacturing practices

  • Standards and Reporting Adverse Events to FDA

  • registration

  • general recordkeeping requirements

Class II : General Controls With Special Controls

Class II devices are also subject to general controls.

  • Labeling requirements (information that must be included on a product label)

  • Device specific mandatory performance standards

  • Device specific testing requirements

Class III : General Controls and Premarket Approval

Usually, Class III devices support or sustain life, are implanted in the body, or have the potential for unreasonable risk of illness or injury. Examples include pacemakers, breast implants, and HIV diagnostic tests. As a result, Class III devices require premarket approval. To receive this, a manufacturer must prove that a device is safe and effective. Class III devices are also subject to general controls.

Step 2

Preclinical Research - Prototype

Researchers build a device prototype, or an early version of a medical device. At this stage, the device prototype is not for human use. Researchers test the prototypes in controlled laboratory settings. Refining the prototype provides researchers with important information about the product’s potential use for people. The prototype process attempts to reduce risk of harm in people. However, it is not possible to eliminate risk entirely.

Step 3

Pathway to Approval

Device Application Process

Because there is so much variation in the classification of devices, developers have a variety of options.

Federal Food, Drug, and Cosmetic Act, section 513, established the risk-based device classification system for medical devices. Each device is assigned to one of three regulatory classes: Class I, Class II or Class III, based on the level of control necessary to provide reasonable assurance of its safety and effectiveness.

As device class increases from Class I, to Class II to Class III, the regulatory controls also increase, with Class I devices subject to the least regulatory control, and Class III devices subject to the most regulatory control.

  • Class I : Most exempt from premarket submission

  • Class II : Premarket Notification 510(k)

  • Class III : Premarket Application PMA

  • De Novo

  • Humanitarian Device Exemption (HDE)

The regulatory controls for each device class include : 510(k)

Requires proof that the devices is substantially equivalent (SE) to a legally marketed device that is not subject to Premarket Approval (PMA).

Substantial Equivalence

A device is considered substantially equivalent if it has the same intended use and the same technological characteristics as a legally marketed device. A legally marketed device was :

  • legally marketed prior to May 28, 1976 ("preamendments device"), for which a PMA is not required, or

  • reclassified from Class III to Class II or Class I, or

  • found substantially equivalent through the 510(k) process.

Premarket Approval (PMA)

PMA refers to the scientific and regulatory review necessary to evaluate :

  • the safety and effectiveness of Class III devices or

  • devices that were found not substantially equivalent to a Class I or II predicate through the 510(k) process.

PMA is the most involved process. To reasonably determine that a device is safe and effective. PMA requires :

  • scientific evidence that the possible benefits to health from the intended use of a device outweigh the possible risks

  • that the device will significantly help a large portion of the target population.

Step 4

FDA Review

If medical device developers have enough information on a device’s safety and effectiveness, they can file an application to market the device to the public. The type of application they file depends on the device’s class.

  • Humanitarian Device Exemption

  • Premarket Notification or 510(k) - Class I, II and III Devices

  • Premarket Approval Application - Class III Devices

Step 5

FDA Post-Market Safety Monitoring

Although premarket clinical trials provide important information on a device’s safety and effectiveness, it is possible that new safety concerns will emerge once the device is on the market. As a result, FDA continues to monitor device performance after a device has been approved.

  • Manufacturer Inspections

  • Reporting Problems

  • Active Surveilance

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