U.S. FDA Medical Device 510(k) Approval

510(k), also called Pre-marketing Notification (PMN), is the article number of the U.S. Food, Drug, and Cosmetic Code that specifies that manufacturers who are required to register information with the US government shall provide notification at least 90 days prior to placing a product on the market.

The US Food and Drug Administration (hereinafter, US FDA) divides the products notified through this regulation into 3 grades and identifies whether it is the same product as a medical device that has been released on the market or a new medical device that has never been released.

More specifically, medical device manufacturers must perform pre-marketing notification prior to initial commercial distribution of a product or prior to distribution of an approved product where major change has been made to the extent that it affects the safety and efficacy/effectiveness of the product. This major change include changes in product design, materials, chemical composition, energy sources used, production procedures, or intended use.

[U.S FDA 510(k)]

510(k) submission process

Introduction

For the document submitted for pre-marketing notification (510(k)), the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostics and Radiological Health (OIR) comprising of biomedical engineers, physicians, microbiologists, chemists, and other medical device experts, from the departments of the US FDA’s Center for Device and Radiological Health (CDRH), will review. 

Access and Application Notice Process

Applicants for 510(k) should submit two copies of the documents to CDRH’s Document Control Center (DCC) at the address: 

Food and Drug Administration Center for Devices and Radiological Health Document Control Center – WO66-G609 10903 New Hampshire Avenue Silver Spring, Maryland 20993-0002 

One of the two copies shall be submitted electronically.

When the DCC receives 510(k) submission, a unique number is assigned to the document. Generally, this number is referred to as “510(k) number” or “K number.” This K number consists of six numbers followed by the letter K. The first two digits indicate the year of submission, and the last four digits indicate the order of submission in that year. In other words, the first submitter of the year is assigned 0001, and higher numbers are assigned as the order continues.

After submission, the DCC will check the following 2 items upon receipt.

- Receipt of the application fee  

Note: The submission fee of 510(k) is charged by the date that the US FDA receives the document, not the date the submitter sends it. 

- Confirmation of the electronic copy received 

If there is a problem with reasonable beneficiary fee or receipt of the electronic copy, the DCC will send a suspension notice to the 510(k) submitter within 7 days of receipt. The submitter shall resolve any problems related to the beneficiary fee or receipt of the electronic copy within 180 days from the date of sending of the suspension notice. If not resolved within 180 days, the 510(k) submission will be invalidated and deleted from the system. The submitter shall reapply through a new application process.

[510(k) Confirmation]

The US FDA’s deadline officially set for 510(k) process is 100 days. This is calculated from the date the US FDA receives the document to the final decision, except during the period in which such submission is under suspension due to a request for additional information. The final decision may be either Substantially Equivalent (SE) or Not Substantial Equivalent (NSE).

Upon final decision, the US FDA will issue a decision and sends it to the email address specified in the submission. 

The submission determined to be Substantially Equivalent (SE) is considered to be “approved.” The approved 510(k) submission will be registered in the US FDA’s 510(k) database which updates weekly. 

FDA Receives 510(k) Submission.

 

[Medical Device Registration and Notification]

US FDA registration of company and product

An owner or operator of the business (facility or equipment) involved in production or distribution of medical devices intended for use in the US shall register the business in the US FDA annually, and this process is called the facility registration process.

The US Congress authorized the US FDA to collect annual fee from the businesses. For more information of the businesses responsible for registration and fee, please see “Medical Device User Fee Amendments (MDUFA).”