510(k) Submissions

Wake Pharma acts as the FDA regulatory consultant for medical device and IVD companies from around the world seeking Food and Drug Administration (FDA) approval to sell their products in the United States. One of the first steps for medical device companies that manufacture Class II, Class III and some Class I medical devices and IVDs is to file a Premarket Notification, also known as a FDA 510(k) submission, with the Food and Drug Administration.

Technically, the FDA does not “approve” medical devices or IVDs for sale under the FDA 510(k) premarket notification process. The FDA gives “clearance” for them to be sold. To be cleared for sale by the FDA, the first step is to identify a Predicate Device(s), which is a medical device already cleared by the FDA and is similar to the one for which FDA approval is being sought.

As an FDA consulting firm, we have successfully prepared and submitted FDA 510(k) submissions for medical device and IVD companies worldwide.

Types of 510(k) Applications

There are 3 types of 510(k) applications that can be submitted to the FDA: Traditional, Special and Abbreviated

TRADITIONAL 510(k) submission

This is the most common 510(k) application submitted to the FDA. Most companies introducing a new Class 2 medical device must submit a traditional 510(k) Premarket Notification. This is a full 510(k) that includes all 21 sections.

ABBREVIATED 510(k) submission

When you submit an Abbreviated 510(k), you are providing summary reports that demonstrate your use of guidance documents, special controls or Declarations of Conformity to recognized standards to expedite review of your submission. You might qualify to submit an Abbreviated 510(k) if:

• FDA Guidance document(s) exists
• Special controls have been established
• The FDA has published a recognized Consensus Standard that you have followed

SPECIAL 510(k) submission

This is used when a modification has been made to a medical device that already has 510(k) clearance. It allows the manufacturer to declare conformity with the Design Controls set out of 21 CFR Part 820 without providing the data. The special 510(k) also applies to Preamendment Devices (those approved before May 28, 1976).

Who must submit a FDA 510(k) Premarket Notification?

In general, manufacturers introducing Class II medical devices or IVDs to the US must submit a 510(k) to the FDA. A 510(k) is also required for manufacturers changing the intended use of their medical device, or changing the technology of a cleared device in such a way that it may significantly affect the device’s safety or effectiveness.

Step 1: 510(k) Preparation Consulting

To ensure a successful 510(k) submission, Techlink International takes the following approach:

• Evaluate the classification of your medical device or IVD and determine the proper FDA product code and regulation number.
• Determine the predicate device(s) suitable for use in your 510(k) submission.
• Review testing requirements according to the FDA guidance documents and required standards.
• You will receive a detailed product-specific list of documents needed for review by our 510(k) consulting team.
• With client help our team will prepare a technical comparison of your medical device to other predicate devices with FDA 510(k) clearance.

Step 2: FDA 510(k) Submission Consulting

Once the requested files have been received and evaluated our 510(k) team will:

• Prepare all sections of the FDA 510(k) application.
• Coordinate your payment of FDA 510(k) submission fees on your behalf.
• Submit the 510(k) to the FDA and be available as your FDA consultant to answer follow-up questions from the FDA reviewer.
• Upon successful clearance of your device, we will guide you through the Establishment Registration process with the FDA.

FDA Time Line

Once the 510(k) application has been submitted the FDA has 90 days to review it. Please note that review does not mean clearance. During the review process, they likely will ask you for additional information at which time the “clock” is stopped and then resumed upon the FDA’s receipt of your answer to their questions. Upon successful clearance, the FDA will mail you a letter, with an assigned 510(k) number, that says they “have determined that your device is substantially equivalent to legally marketed predicate devices – and you may therefore begin to market your device subject to the general controls provisions of the Food, Drug and Cosmetics Act.”

FDA fee to review your 510(k) application

The FDA charges to a review 510(k) application. This fee is due upon the submission of each new 510(k) application. An annual Establishment Registration fee is also charged to all companies. The Establishment Registration fee is valid for one fiscal year (October 1 and ends September 30 each year). All prices in USD.