FDA Regulations For Medical Devices: An Overview

Are you planning to import, export, or manufacture medical devices in the United States? In this guide, we introduce you to lab testing requirements, classification, device registration, labeling, GMP and premarket submissions.

Mentioned Products

• Medical thermometers
• Medical masks and respirators
• Medical gloves
• Medical gowns

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Medical Devices Classification

First of all, importers shall determine the classification of their medical device, which is based on the device description, intended use, and risk associated with the devices. Medical devices are classified into three regulatory classes:

• Class I – Lowest risk and general control required
• Class II – Moderate risk and special control required
• Class II – High risk and special control required

Below we provide some medical device classification examples.

Class I

• Clinical color change thermometers
• Examination gowns
• Medical gloves

Class II

• Surgical N95 respirators
• Electronic thermometers
• Surgical gowns

Class III

• Defibrillators
• High-frequency ventilators

If you are not sure how to classify your medical devices, the FDA provides a classification database where you can enter your device’s name or type and assess its classification.

Premarket Submission

In order to assess the compliance of the medical device, the FDA requires premarket submission for most of the medical devices (excluding exempted devices). Importers shall provide sufficient support to show that their medical devices are safe and effective, with respect to similar devices already approved, marketed, and sold in the US.

510 (k) Premarketing notification

Class I and Class II medical devices require 510 (k) premarketing notification at least 90 days prior to the placement of the devices in the US market. Most of the class I devices are exempted from the 501(k) premarketing notification requirement; the FDA also published a list of class II devices that are exempted as well.

Here are some exempted medical devices for the premarketing notification:

• Dental devices
• Ear, nose and throat devices
• Radiology devices
• Physical medicine devices
• Clinical toxicology devices

For a list of exempted medical devices, importers can visit the FDA’s website.

Premarket notification submission requirements

For non-exempted devices, Importers must provide a table that compares their medical devices and similar devices that are already placed in the US market. Importers shall compare their functionality, test results, applicable standards or regulations, product specification, and other relevant information.

In summary, importers shall provide the following information for the submission:

• Product specification
• Registration number
• Product classification
• Production comparison table
• Proposed labeling
• Registered person contact
• Compliance statement
• Relevant test reports

You can learn more about the submission requirements of your medical devices on this page.

Requirements for devices that are exempted

510(k) exempt devices do not imply that there are no FDA requirements when placing the product in the US market, instead, 510(k) exempt devices still need to follow certain FDA regulations including GMP, FDA registration, and the labeling requirement.

Premarket Approval Application (PMA)

Class III medical devices present a high potential risk of injury to the users or patient, therefore, the FDA requires that importers must submit a premarket approval application for all Class III medical devices, and the devices must obtain approval before placing them in the market.

The PMA is known as the most stringent regulatory procedure for medical devices. The PMA requires to evaluate class III medical devices in scientific aspects. Therefore, Class III devices including human life-supporting devices must submit the PMA to obtain approval from the FDA.

The PMA shall demonstrate the safety and effectiveness of the Class III devices. The applicant shall provide valid clinical information and scientific analysis to the quality control audit, then submit to the FDA.

Notice that some class III preamendment devices are required to submit both the 510(k) notification and the PMA. You can find more detail about the preamendment devices here.

Differences among 510 (k) premarketing notification and PMA

In order to get FDA’s approval or the clearance, for most medical devices importers are required to submit either the 510(k) premarketing notification or the PMA.

The 501(k) premarketing notification is applicable for Class I or Class II devices such as powered wheelchairs and surgical gowns, while the PMA is for Class III medical devices such as implanted medical devices.

Other types of submissions

Other than the 510(k) premarket notification and the PMA, there are three more types of premarket submissions for medical devices. Below you find an overview.

Investigational Device Exemption (IDE)

The IDE submission is applicable for clinical research on investigational devices, which are used to collect data from a device and evaluate its safety and effectiveness. It requires approval from the Institutional Review Board, which is in charge of biomedical research review and monitoring.

De Novo

If your medical device has no existing classification or regulation, i.e. it’s a novel and innovative device, then you are subject to submit the De Novo submission for placing your devices in the market.

Humanitarian Devices Exemption (HDE)

The HDE is specifically for humanitarian use devices, which is a medical device intended to benefit patients in the treatment of a rare disease with no more than 8,000 individuals in the US per year. Importers shall demonstrate the assurance of safety and probable benefit of the devices.

Lab Testing

When you submit your medical devices to the FDA, you are often required to provide test reports concerning the applicable standards, such as ASTM standards. Importers can obtain the test report from either manufacturers or third-party lab testing companies.

In addition, the FDA has established a voluntary Accreditation Scheme for Conformity Assessment (ASCA) Pilot program, in order to expedite the medical devices’ registration progress including test report reviews.

Once the FDA grants a testing laboratory with ASCA accreditation, the lab can conduct testing for the medical devices according to ASCA-eligible standards.

Labeling Requirements

The Code of Federal Regulations (CFR) Title 21 Part 801 provides the labeling requirements for medical devices. It covers the general labeling provisions, labeling requirements for unique devices and over the counter devices. Importers shall refer to the regulation and submit the proposed label for approval.

Here some examples of information that shall be included on medical devices’ labeling:

• Manufacturer contact
• Intended uses
• Compliance mark
• Clinical data of the medical device
• Country of origin
• Expiration date

Depending on different types of medical devices, importers can refer to the applicable requirement for their labeling here.

Good Manufacturing Practice (GMP)

Medical devices that are subject to premarket notification or exempt from notification, are required to comply with CFR Title 21 Part 820, which is a quality system regulation. The Current Good Manufacturing Practice (CGMP) regulations set requirements for the production methods, facilities, and control during the manufacturing process.

In most cases, medical device manufacturers shall establish a quality management system (QMS) and maintain procedures to comply with the requirements under the CFR Title 21 Part 820. In practice, importers shall prepare a file that includes all relevant documents to show compliance for the GMP requirement.

Registration and Listing

Importers are required to register their medical devices via the FDA’s online system. They will then obtain a registration number, which is needed during the medical device importing process. For instance, importers will need to provide the establishment registration number during the process of premarketing notification.

Required information

Here is a brief summary of the required information for registration:

• Name and mailing address of the device establishment
• Website address of the device establishment (if applicable)
• Contact information of the owner or operator
• Contact information of establishment’s official correspondent
• All trade names used by the establishment

Additional requirements for non-US companies

Any foreign company that wants to import medical devices into the United States must appoint a US agent, which has the responsibility to facilitate the communication between the FDA and the foreign company, responding to any FDA’s questions about the imported devices and more.

Certification of Registration

Recently, we have been dealing with a lot of supplier auditing for medical devices. We noticed that Chinese suppliers often provide “Certification of Registration” to their potential customers.

We have encountered some situations in which the supplier claimed that their medical devices were “FDA approved” and they had the FDA certificate. Turns out that the only certificate they had was the Certification of Registration.

Note that, as per our understanding, the Certification of Registration only certifies that the company has completed the establishment registration and device listing with the FDA. This does not automatically imply that the medical devices have passed all required testing for relevant standards, or are FDA-approved.

As such, a Certificate of Registration is not sufficient for importing medical devices to the US.