Archive for the ‘MDUFMA’ Category

Section 513(g) – How to request classification information from the FDA

In 510(k), Device Classification, MDUFMA, Medical Device, Section 513(g), US FDA on September 11, 2012 at 11:28 am

If your company is currently registering with the US FDA, you are probably reviewing the guidance document this month for the FY2013 user fees. On page 6 and 7 there is a table of these fees, but you might have overlooked 513(g). Section 513(g) is a provision in the law that allows for companies to request device classification information from the FDA.

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If your company was developing a new product, and you were having difficulty identifying the regulatory pathway, 513(g) is your friend. In my opinion, these fees are modest: $3,348 = Standard Fee; and $1,674 = Small Business Fee. Most consultants will charge at least ten hours of consulting to identify the regulatory pathway for a company. I would charge quite a bit less, because it takes me a lot less than ten hours. I still think the FDA’s pricing is a good deal, because getting information directly from the source is always more valuable than an “expert”.

The US FDA has published a guidance document explaining the process for 513(g) requests. This guidance document was released on April 6, 2012. The guidance explains what information companies need to provide in order to submit a 513(g) request. The guidance also has a fantastic list of FDA resources on page 5. These are the very same resources that the “experts” use—including yours truly.

Just as any good lawyer tries to avoid asking questions that they don’t already know the answer to, I recommend that you first try using these resources yourself. Once you think you know the answer, your request for classification information will be easier to organize.

Here’s how I would proceed:

Step 1

Identify another device similar to yours. If you can’t do this, you need serious help. You need a similar device that is already sold on the market to use as a predicate device. If you cannot identify a predicate, then you can’t use the 510(k) process—or you don’t know your competition. Either way, you’re all buggered up. For example, if you are trying to launch a new topical adhesive made from cyanoacrylate—“Dermabond” might be the first predicate device that comes to mind.

Registration and Listing Database Entry Form

Step 2

Use the registration and listing database on the FDA website to find the company that makes the device. The link for this is #4 on my helpful links page. This link also will provide you with connections to the classification database—which you can use to find the classification for any device. However, the registration and listing database is less likely to lead you astray. When I type “Dermabond” into the field for the proprietary device name, I get a list of five different product listings.

Listings for “Dermabond”

Step 3

Clicking on any one of these five will take you to a listing page for the corresponding company. On that page, you will find the three-letter product code that identifies the device classification and the applicable regulations for that device.

One of the 5 Dermabond Listings

Step 4

Clicking on the three-letter product code (i.e. – “MPN” in our Dermabond example), this takes you to the Product Classification page. This is where you will find that Dermabond, and other tissue adhesives, are Class 2 devices that require a 510(k) submission. In addition, the Product Classification page identifies an applicable guidance document to follow for design verification and validation testing. This is also called the “Special Controls Document”.

MPN Product Classification

Step 5

Click on the “TPLC Product Code Report” link. This link will provide you with a report of all the 510(k)’s recently granted to your competitors, the problems customers have experienced with their products, and the recalls for the past five years. This is extremely valuable information as a design input—as well as competitive information for your marketing team.

TPLC Report for Product Code “MPN” – Topical Adhesive

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