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FDA Medical Device : Determining your path to U.S market

Aug 08 2022

Classification of Medical Devices

For your medical device to entrance in the U.S market, classifying your medical device will be your first step.

The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Class I devices generally pose the lowest risk to the patient and/or user and Class III devices pose the highest risk.

Class I: low to moderate risk medical device

If your product with exemptions, your path will applicable general control, Class I.

It is required your establishment registration and product listing.

Class II: moderate to high risk medical device

It is applicable special controls as class II devices and you need to prepare a 510(k) submission to FDA for entrance U.S market.

It is required your establishment registration and product listing.

Class III: high risk medical device

Premarket Approval (PMA) will be your path for entrance U.S market.

For more information about the medical device classification process, see Classify Your Medical Device.

Reclassification of Medical Devices

The main purpose of reclassification is to apply the appropriate level of regulatory controls for a device type based on the most current information regarding its safety and effectiveness.

Reclassification is applied to a device type and not an individual device.

The sections of the FD&C Act that address device reclassification are:

  • Section 513(e) - Applies to classified devices, except those devices currently classified into class III under Section 513(f)(1).

  • Section 513(f)(3) - Applies to postamendments devices classified automatically into class III under Section 513(f)(1).

Section 513(e)

For already-classified devices, except those currently classified into class III, the FDA may initiate, or respond to an interested person's petition for, reclassification of a device type.

In either case, the basis for reclassification is the availability of new information regarding the device.

The FDA may issue a final order reclassifying a device following:

  • valid scientific evidence about the device, including its public health benefit, and the nature and, if known, the incidence of risk from using the device

    • For reclassification from class II to class III: a discussion of why general and special controls are not sufficient to provide a reasonable assurance of safety and effectiveness.

    • For reclassification from class III to class II: a discussion of why general and special controls are sufficient to provide a reasonable assurance of safety and effectiveness.

  • The FDA’s convening of a meeting of a device classification panel.

  • The FDA’s considering of comments received during the set period of time for submitting comments to the public docket for the proposed order.

Section 513(f)(3

For a postamendments device classified automatically into class III, FDA may initiate a reclassification or respond to a petition from an interested person who requests reclassification of a device type to either class I or II.

1. If you are considered to change the classification of your device type, the device must meet the definition of devices that belong in that class.

2. If the FDA receives a petition requesting a reclassification, the FDA reviews the petition for any deficiencies that prevent the FDA from making a decision on it.

3. If the FDA determines that the petition contains no such deficiencies, the FDA may, for good cause, refer the petition to an appropriate device classification panel to review the information and make a recommendation on the petition.

4. After the information is considered, the FDA will approve or deny the petition. If the FDA approves the petition, an order will be issued describing the reasons for approving the petition and identify the risks to health, if any, presented by the device to which the order applies.

Preamendments Devices

A preamendments device is one that was in commercial distribution before May 28, 1976, the date the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) were signed into law. These devices were initially classified as Class I, II, or III.

The FDA may on its own initiative or in response to a petition, reclassify a previously classified preamendments device based on “new information.”

Some preamendments device types were initially regulated as Class III through the 510(k) program, with the intent that the FDA would either reclassify them into Class I or II or would keep the Class III classification and call for premarket approval (PMA) applications.

Postamendments Devices

Devices that were not available on the market before the passage of the Medical Device Amendments of 1976 are generally referred to as postamendments devices. These are automatically classified into Class III, regardless of the risk they pose.

Novel postamendments devices of low to moderate risk may be eligible for classification in Class I or II through the de novo classification process which is described in section 513(f)(2) of the FD&C Act.

Provision provides registration, clearance, labeling compliance

and even initial importer services.

We will streamline the regulatory processes so that our clients can utilize

their time and money most efficiently.

Experience the best FDA approval directions and solutions!

If you have questions about FDA regulation of medical devices

or importing of medical devices to the United States,

Office 1-909-493-3276



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