In today’s blog, we will explore about Introduction of Medical Device FDA Regulation. Whether you’re a startup or established manufacturer, understanding the Premarket Approval is vital for ensuring regulatory compliance and bringing your product to the market

It is also important for Medical Device QA/RA Professionals to know in detail about Introduction on medical device FDA regulation.

Let’s get into the topic.

Introduction on Medical Device FDA Regulation

Medical Device Determination:

For a device to be considered as medical device, it shall fall under the definition of medical device as per FDA regulation.

US FDA guidelines to market medical device in United States:

Marketing your Medical Device in US is based on the risk of the Medical Device and regulatory controls needed to ensure the safety & effectiveness of the medical device.

Classification of medical device:

In FDA medical device classification is categorized as Class I, Class II & Class III. In FDA medical device classification, risk and regulatory controls increases from Class I to Class III.

The following are the details about FDA regulation Classification of medical device.

If the risk of your medical device is low & it needs general regulatory controls, it is classified as Class I medical Device. Low risk medical device can have minimal potential for harm.

If the risk of your medical device is moderate & it needs general regulatory controls & special regulatory controls, it is classified as Class II medical Device.

If the risk of your medical device is high & it needs general regulatory controls & PMA, it is classified as Class III medical Device. High risk medical devices are life sustaining & life supporting or present potential unreasonable risk of illness or injury

Based on US FDA guidelines on classification of medical device, applicable premarket submission types for marketing your device in United States can be selected.

Introduction on Medical Device FDA Regulation

Types of Premarket Submission under FDA regulation:

510(k) Premarket Notification

PMA Premarket Approval

De Novo Classification Request

Humanitarian Device Exemption

Introduction on Medical Device FDA Regulation

Regulatory Controls

The US FDA guidelines on Regulatory Controls are further classified as General Regulatory Controls & Special Regulatory Controls.

General Regulatory Controls:

FDA General Regulatory Controls are applicable for all classes of medical devices under FDA regulation. The following are the sections of general regulatory controls applicable for medical devices.

Section 501 – Adulterated devices
Section 502 – Misbranded devices
Section 510 – Registration of producers of devices
Section 516 – Banned devices
Section 518 – Notifications and other remedies

- Notification 518(a)
- Repair, Replacement, Refund Provisions 518(b)

Section 519 – Records and reports on devices
Section 520 – General provisions respecting control of devices intended for human use

- Restricted Devices 520(e)
- Quality System Regulation, Good Manufacturing Practices 520(f)

As per US FDA guidelines, if a specific medical device is exempted from any of the general regulatory controls, such exemptions will be explained in the classification regulation of the specific medical device.

Special Regulatory Controls:

FDA Special Regulatory Controls are applicable for class II medical devices under FDA regulation. The special regulatory controls applicable for medical devices are usually product specific like the following.

Performance standards
Special labeling requirements
Post market surveillance
Premarket data requirements
Guidelines
Patient registries

As per US FDA guidelines, if General regulatory controls are not sufficient to ensure the safety and effectiveness of medical device, special regulatory controls of applicable.

Now I hope you have acquired some basic knowledge about the Introduction on medical device FDA regulation. We will meet again with another valuable topic related to MedTech Quality & Regulatory, Biomedical Engineering, Medical Device, Healthcare.

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