FDA 510(k) Guidance

In order to sell medical devices in the United States, manufacturers of devices that don’t require a premarket approval (PMA) must seek an FDA 510(k) premarket notification clearance. The agency provides 510(k) guidance documents, which outline requirements designed to ensure the quality, safety, and efficacy of 510(k) devices.

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What is a 510(k) Device?

Medical devices sold in the United States are classified into Class I, II and III products. If you conduct an FDA 510(k) search of information, you will see that the higher the class, the more regulatory control is involved. Almost all Class I devices are exempt from FDA 510(k) clearance, while most Class II items are considered 510(k) devices. A Class III device typically requires a PMA.

510(k) Summary

Step 1: Determine your type of submission.

There are three types of FDA 510(k) submissions: traditional, special, and abbreviated. A special notification is required if you are introducing a modification to a device that has already been cleared. An abbreviated FDA registration is needed if the following conditions apply to a device: a 510(k) guidance document exists, a special control has been established, a relevant consensus standard has been recognized. A traditional submission is required for a new device or one that doesn’t fall under the other types of submissions.

Step 2: Review 21 CFR 807 Subpart E.

There is no FDA registration form for a 510(k) device, but you will find all requirements in 21 CFR 807 Subpart E. Granted that you are submitting a traditional FDA 510(k) notification, your 510(k) summary should explain the basis for the determination of the substantial equivalence of your device.

Step 3: Identify a Predicate Device

Identify a predicate device or devices that are as similar to your product as possible. Include the 510(k) numbers of the devices. Remember that your goal is to prove substantial equivalence to at least one device that has received FDA 510(k) device clearance.

Step 4: Review Relevant 510(k) Guidance Documents

The FDA provides an array of 510(k) guidances, including device-specific guidance and general guidance documents. Review the documents relevant to your product. Device-specific guidances describe the information you need to prove substantial equivalence.

Step 5: Choose a Format

The FDA provides a guidance for a traditional format, including outline, sections, and a summary listing. The agency also accepts the globally harmonized STED format, which refers to the format in a document called “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices.”

When a 510(k) Guidance is Required

If there are any doubts as to whether your device requires a 510(k) submission, go over the circumstances below for clarification. These conditions should be considered apart from any exemptions by regulations.

When a 510(k) is Required

When a 510(k) is Not Required

If your firm didn’t market the device before May 26, 1978, it will require a 510(k). If you’re introducing the commercial distribution of a device for the first time, that device will need a 510(k).

A device doesn’t need a 510(k) if it was commercially sold before May 26, 1978, and there’s no significant change in design, components, and intended use.

If you sell components of a medical device directly to end users as replacement parts, you need a 510 (k).

If you sell unfinished devices or components to another firm for assembly or further processing, you don’t need a 510(k).

There’s a significant change to the device that could affect safety and efficacy.

You distribute a locally manufactured device for another firm.

If a device already legally distributed is going to be marketed for a different intended use.

You are an importer of a foreign-manufactured device that has already been cleared. You are a repackager or labeler of a device whose condition or labeling has not changed.

How to Perform an FDA 510(k) Search

Performing a diligent FDA 510(k) search is important to demonstrate substantial equivalence to another device that has been cleared. The FDA provides a database where you can search for a 510(k) device by name, product code or 510(k) number. Search results will include a 510(k) summary, which refers to a brief safety and effectiveness information for the device.

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