How to Get FDA Approval for Medical Devices

The U.S. Food and Drug Administration (FDA) regulates several industries in the United States. Medical devices. Food and beverages. Cosmetics.

Each industry has its own regulations that must be met to gain FDA approval. But complying with regulations and getting FDA approval is a time- and resource-intensive process.

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What Is FDA Approval?

FDA approval means that the FDA has formally approved your product (in this case, your medical device). This is important to establish that your device is safe and effective.

But to get FDA approval, you’ll need to prove compliance.

What Is FDA Compliance?

FDA compliance means following product safety and quality system regulations set by the FDA. You’ll need to prove compliance with these regulations in order to get your device out to market in the U.S.

⚕️ Biotech company Fractyl Health achieved CE mark certification 12 months ahead of schedule.

Learn how they did it. >>

FDA Compliant vs. FDA Approved

So, what’s the difference between FDA compliant and FDA approved?

All FDA approved products are FDA compliant. But your product could be FDA compliant — and pending formal FDA approval.

And you may only use the phrase “FDA approved” if you’ve received a letter from the FDA confirming that your device is approved.

FDA Regulations for Medical Devices: 21 CFR

Title 21 of the Code of Federal Regulations, also known as 21 CFR, is a critical regulation for medical devices. It sets the requirements for FDA approval of medical devices. 

Electronic Records (21 CFR Part 11)

21 CFR Part 11 regulates the use and storage of electronic documents and signatures. This is important for compliance documentation.

Need more information about 21 CFR Part 11? 

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Establishment Registration and Medical Device Listing (21 CFR Part 807)

21 CFR Part 807 requires you to register with the FDA. It also requires you to list your devices.

Pre-Market Notification ­510(k) (21 CFR Part 807 Subpart E)

21 CFR Part 807 Subpart E applies to Class II devices. Class II devices are low-to-moderate risk. And this classification is typically used for more established products, such as an X-ray machine.

Pre-Market Approval Application (21 CFR Part 814)

21 CFR Part 814 applies to class III devices. Class III devices are higher risk. So, this classification is typically used for more breakthrough products, such as an implanted defibrillator.

Investigational Device Exemption (21 CFR Part 812)

An investigational device exemption (IDE) allows your device to be used in a clinical trial.

Quality System Regulations (21 CFR Part 820)

21 CFR Part 820 outlines the FDA’s design control guidelines.

There are three key areas to pay attention to in this regulation.

The design input guidelines from 820.30(c) are critical for setting requirements:

Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient.

The design output guidelines from 820.30(d) are critical for testing requirements:

Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements.

The design review guidelines from 820.30(e) are critical for managing development:

Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development.

Labeling (21 CFR Part 801)

21 CFR Part 801 requires labels on your device to be descriptive and informational.

Medical Device Reporting (21 CFR Part 803)

21 CFR Part 803 requires you to report incidents in which your device may have caused or contributed to serious injury or death.

How to Get FDA Approval for Medical Devices

To get FDA approval for your medical device, you’ll need to go through the following five steps.

1. Know Your Device’s Classification

Medical devices fall into three classes:

• Class I
• Class II
• Class III

You should know your device’s classification before the development process begins. The class of device will correlate to how you’ll need to manage requirements and testing.

The class of device will also determine which regulations you’ll need to comply with. Class I medical devices are the lowest risk. So, they’re generally not subject to a pre-market review. However, Class II and Class III devices are subject to pre-market reviews.

2. Develop a Prototype

The next step is to develop a prototype. This prototype won’t be ready for human use. Instead, its main use is for testing in laboratory environments — and sufficiently reducing risk before it is used by humans. It may then go into clinical trials.

3. Submit Your Applications (If Applicable)

To get FDA clearance to market and distribute your class II or class III device, you’ll need to submit a pre-market notification or application.

As part of this, you’ll need FDA verification and validation of your device.

FDA Verification

FDA verification is important for making sure the requirements you set are fulfilled. You should be able to answer the question…

Are you designing the device right?

You can answer yes if:

• Requirements are implemented.
• Requirements are verified.
• Requirements of standards are met.

FDA Validation

FDA validation is important for making sure the device you deliver fulfills the needs of the market. You should be able to answer the question…

Are you designing the right device?

You can answer yes if your device meets the needs of:

• Device users.
• Stakeholders within your company.
• Regulatory stakeholders.

Get 6 Tips for Medical Device Development  
Read the blog: Design Verification vs. Validation >>

4. Wait for FDA Review and Approval

The next step is to wait for the FDA to review and approve your device.

5. Maintain FDA Compliance

You’re not in the clear once you’ve received FDA approval. You’ll need to ensure your device stays in compliance for its lifespan.

Traceability Accelerates Time-to-Compliance

Getting FDA approval requires careful documentation of compliance in your development processes.

But manually managing and tracking those activities takes time — and it’s prone to error. That simply isn’t sustainable, especially if you want to deliver your device to market on time.

Traceability accelerates the process. It creates links across your development artifacts. So, your requirements are traced directly to code, tests, and issues. And you’ll be able to instantly see what has been implemented and passed testing.

Traceability Verifies and Validates

Traceability makes it easy to verify and validate your device.

So, you’ll be able to verify that your requirements are met — especially regulatory requirements. And you’ll be able to validate that your device works as intended and meets the needs of your users.

Need to create a traceability matrix to prove compliance? 

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Essential Traceability Components for Medical Device Development

Additional Benefits of Traceability

Getting FDA approval isn’t the end. You’ll need to stay in compliance as regulations — and your product — change.

Traceability can help you maintain FDA compliance for the long-term. And it prepares you for the inevitable audit.

When the FDA inspects your device, you’ll need to have the documentation ready to prove you’ve met their compliance requirements. By establishing traceability early on, you’ll the make the audit as painless as it can be.

Plus, by tracking and linking requirements, code, tests, and issues, you’ll:

• Identify potential hazards — before they become problems.
• Reduce (or eliminate) recalls.
• Prevent lawsuits.

Compliance Is Easy — With the Right ALM Tools

Helix ALM makes it easy to manage and track requirements, testing, and issues — all in one place. And it automatically creates traceability across these items. That helps you prove compliance faster, so you can get your device to market on time — without sacrificing quality or safety.

Try Helix ALM today for free, or watch this demo of Helix ALM to see exactly how it:

• Automates traceability.
• Lets you easily configure any type of workflow.
• Automatically traces test cases back to requirements.
• Accommodates FMEA, ASIL, Hazard Analysis, and more with built-in risk tracking.

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Note: This blog was first published in January, 2020 and was updated for quality and accuracy in October, 2023.

More Resources on FDA & Medical Devices

FDA Design Controls: Medical Device Developer Guide

FDA Compliance and Medical Device Development Process