Intro to FDA Medical Device Development

In order to market and sell a medical device in the United States, the device must comply with FDA Section 510 regulations in order to ensure quality and safety standards have been met. As the level of impact/potential consequences of this device increase, the classification number increases in kind, moving from Class I to Class II and III devices.

Generally speaking, there are two main paths to submitting for approval under the 510k regulations. If the device can be determined “substantially equivalent” to a device on the market prior to May 28, 1976, this new device may be determined to be a “predicate device”, and then the device would have to submit a Premarket Notification.

If the device is substantially different from other existing devices, then the device would have to submit a Premarket Approval, a process that is generally more involved.

Now, just to stir things up, if the device can present a substantial risk to users or patients, it may be classified as a Class III device, which automatically requires a Premarket Approval, even if the device is a predicate device.

Although companies and consumers may grumble about the cost and time required to follow the FDA regulations, I’m actually all in favor of them, and I find that addressing the FDA’s documented (!) guidelines and concerns means the product will be:

• Safer

• Easier to Use

• Faster to Design, Manufacture, and Market

• Present a lower risk to users, patients, and to the company

Understanding FDA Medical Device Classes

Now that we've introduced som preliminary concepts, here's a quick overview for how Class I, II, and III devices compare

Class I

Not intended to help support or sustain life or be substantially important in preventing impairment to human health, and may not present an unreasonable illness or injury

Examples: Band-Aids, Exam Gloves, hand-held surgical instruments

510k Status: Most do not need 510k premarket notification

Class II

Device may help support life or medical procedures, generally not as invasive or high risk as a Class III device

Examples: Acupuncture needles, powered wheelchairs, infusion pumps, surgical drapes, implantable radiofrequency transponders for Patient ID

510k Status: Some Class II devices are exempt from premarket notification; refer to FDA site to determine what may apply

Class III

High risk device that may pose a significant risk of illness or injury. Specifically, these devices will usually support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury

Examples: Implantable pacemaker, pulse generators, HIV diagnostic tests, AEDs, endosseous implants

510k Status:

Requires 510k Premarket approval, a process that is more involved and requires submission of clinical data to support claims made for the device.

More FDA Landmark Regulations

Now that we've introduced the basics, let's get to the specific references. Once you’ve been in the business a while, these letters and numbers roll off your tongue, but at first it seems like a maze. Here’s a list of common terms, with brief descriptions. As a disclaimer, these are cheat sheet definitions. To learn more, please research the regulation requirements more thoroughly!

21 CFR Part 807

Annual electronic registration with the FDA of medical device, manufacturer, and distributor entities. This runs on an October – September calendar.

510k Premarket Notification, 21 CFR Part 807 Subpart E

Demonstrates that the devices is substantially equivalent to one or more devices in legal commercial distribution prior to May 28, 1976, or another device determined by the FDA to be substantially equivalent.

If a 501k premarket notification is required, a device cannot be commercially distributed until the FDA issues a letter of substantial equivalence in response to the 510 submission.

510k Premarket Approval, 21 CFR Part 814

Approval process that is required for high risk Class III medical devices or devices not found substantially equivalent to previously approved Class I and II devices that have passed through the 510k process.

A Premarket Approval is more involved and requires submission of clinical data to support claims made for the device.

Investigational Device Exemption IDE – 21 CFR Part 812

Allows the device to be used in a clinical study in order to collect safety and effectiveness data required to support and Premarket Approval Application or Premarket Notification submission to the FDA. This must be approved by a FDA IRB before the study can begin.

Quality System Regulation (QS)/Good Manufacturing Pratices (GMP)

21 CFR Part 820

Quality system regulations that cover methods used within facilities and controls used for designing, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices.

Labeling 21 CFR Part 801

Requirements covering the labels on the device, as well as descriptive/supporting information that accompanies the device

Medical Device Reporting 21 CFR Part 803

Incidents in which a device may have caused or contributed to a death or serious injury, or may have malfunctioned without death or injury must be reported to the FDA.

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