A Brief Overview of FDA Medical Device Regulations — Part 2

Welcome back to the final entry of our two-part overview of FDA regulations for medical devices!

In the first part of our series, we covered medical device classifications and listings, establishment registrations, premarket notifications, and premarket approvals. In case you need a quick review, you can check it out here.

We’ve got a lot of ground to cover in this post, so let’s get started!

Investigational Device Exemption (IDE) for Clinical Studies – 21CFR Part 812

The Investigational Device Exemption (IDE) is a provision that lets medical device makers collect safety and effectiveness data about their product before commercialization through clinical studies. This information can then be used to support a Premarket Approval (PMA) application or a Premarket Notification 510(k) submission to the FDA.

IDE is required for devices that cannot get marketing clearance through a PMA application or Premarket Notification 510(k). To proceed with IDE, there are a number of base-line requirements to adhere to:

• If your device carries nonsignificant risk, your clinical study must be approved by an Institutional Review Board (IRB) prior to beginning the study.
• If your device has significant risk, your clinical study must be approved by the FDA and an IRB before the study can commence.
• All patients participating in the study must provide informed consent.
• The device must be labeled that it is only for investigational use or clinical study.
• The study must be monitored.
• All records and reports must be kept organized and turned in.

In some instances, the FDA may need clinical data to provide marketing clearance for 510(k) notification.

Manufacturers must submit their complete IDE application to the FDA. There is no pre-determined format to follow, but certain information such as clinical plan overview, sponsor investigator information, clinical study method, and controls information must be included.

Having an IDE application approved means you can lawfully ship your devices for clinical studies without getting FDA approval for other factors needed for device commercialization.

Quality System (QS) Regulation – 21 CFR Part 820

The QS regulation specifies requirements related to methods, facilities, and controls utilized for the medical device lifecycle. This includes factors like purchasing, designing, manufacturing, packaging, labeling, storing, installing, and servicing of the medical device.

To assure compliance with QS requirements, manufacturing facilities must undergo FDA inspections. Regardless of the type of device being developed, it is up to the manufacturer to establish the regulatory requirements necessary to ensure the device is safe and effective.

This regulation affects all finished device makers who are intent on commercially distributing health tech devices in the United States. A finished device is defined as any device capable of functioning, regardless of whether or not it’s sterilized, labeled, or packaged.

The quality systems for FDA-regulated products are known as current good manufacturing practices (CGMPs). The regulation doesn’t provide specific guidelines for every type of device since there are so many; rather, it functions as a framework that manufacturers must follow to comply.

Labeling Requirements – 21 CFR Part 801

It is required for every medical device to have labeling in the form of descriptions and information to accompany proper device usage.

This regulation specifies the requirements of labeling for the following:

• General Device Labeling
• Use of Symbols
• In Vitro Diagnostic Products
• Investigational Device Exemptions
• Unique Device Identification
• Good Manufacturing Practices
• General Electronic Products

The FDA defines ‘label’ in two ways:

1. ‘display of written, printed, or graphic matter upon the immediate container of any article…’
2. ‘all labels and other written, printed, or graphic matter
   1. upon any article or any of its containers or wrappers, or
   2. accompanying such article’ at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.’

Medical Device Reporting (MDR) – 21 CFR Part 803

In the event that a medical device causes a serious injury or death, or in certain cases of device malfunction, the FDA must be notified.

This regulation acts as a mechanism for the FDA and device makers to identify, monitor, and correct any problems of a particular device in a timely manner. Here are the reporting rules that must be followed by manufacturers, importers, and medical facilities:

1. Manufacturers: When they identify that their device has caused serious injury or death, manufacturers must report the incident to the FDA using the 3500A form. They are also required to notify the FDA if a serious malfunction occurs which could result in serious injury or death.
2. Importers: In the event of injury or death, importers must also inform the FDA. In the case of device malfunction, they must only report to the manufacturers.
3. Facilities: When a facility such as a hospital, clinic, or nursing home finds a device defect that could result in death, they must inform the FDA and manufacturer. Device malfunctions are not required to be reported by facilities, but they can voluntarily inform the FDA through MedWatch.

We Hope This Device Advice Helps!

This concludes our overview of FDA regulations for medical devices. Remember, these regulations apply whether you’re a MedTech developer in San Diego or NYC. It’s good practice to get familiar with them to ensure that your innovation is safe and effective.

For more details, please refer to the FDA website’s overview of regulations.