US FDA : The 510(k) - Part II

In the last column, we began our discussion of the “510(k)” submission to the FDA.  We defined  “premarket notification”, “predicate device”, “legally marketed device”, “Substantial equivalence”, and talked about who is required to submit a 510(k). (See Archives) In this column, we will continue the discussion of Premarket Notification (510(k)) submissions to the FDA.

When Don’t You Submit a 510(k)?

If your medical device is listed by the FDA as an exempt device, it is obvious that you should not make a 510(k) submission.  It also will not help you to submit a 510(k) when a premarket approval application (PMA) is really required!  If you do not intend to market or distribute your product commercially in the United States, you also do not need to submit a 510(k). 

You should not submit a 510(k) if your product was on the market in the United States before May 28, 1976 and you have not made changes since then in it in intended use or in technological changes that could affect its safety or effectiveness. This is because the U.S. Congress “grandfathered” products marketed before passage of the Medical Device Amendments of 1976. 

What if you just want to distribute, under your own name, a medical device made by a foreign company who already has a 510(k)?  Do you also need a 510(k)?  The answer is “no” because the FDA considers you a repackager or relabeler and allows you to distribute the product to end users without a 510(k) unless, of course, you significantly change the device or its claims.  You can put on your label “Distributed by” followed by the name of your company. Similarly, other importers can put their names on a product made by the same foreign manufacturer without submitting their own 510(k)s.

Another option is for you to submit the 510(k) on behalf of the foreign manufacturer if the foreign company agrees.  When the device has a cleared 510(k), you can market it in the U.S.  The FDA will consider you a “manufacturer”.

Do you need to submit a 510(k) if you sell unfinished devices to another firm who then adds other components for assembling or processes the device further?   The answer, again, is “no” unless you sell your components directly to end users for use as replacement parts.

What if you develop a medical device but just want to evaluate or test it. Do you need a 510(k)? The answer is “no!”  Let us say that you want to do clinical testing and need to ship the product to the testing facility.   Do you need a 510(k)?  Again, the answer is “no!” but, in this case you may need to make a different submission called an “Investigational Device Exemption” (IDE).   We will talk about this IDE application in detail in a future column.

510(k)s Come in Three Flavors!

Really, there are three different types of 510(k)s.  Originally, there was just the “traditional” 510(k). We will discuss the other types a little later in this column but first, here is what happened. In 1997, the United States Congress enacted the FDA Modernization Act of 1997 (FDAMA).  This new law incorporated ideas that were already being developed at the FDA that fundamentally changed the way the FDA interacts with industry.  It introduced the concept of using the “least burdensome” approach to meeting FDA requirements.  For example, Section 513(i)(1)(D) states: “Whenever the Secretary requests information to demonstrate that devices with differing technological characteristics are substantially equivalent, the Secretary shall only request information that is necessary to making substantial equivalence determinations.  In making such requests, the Secretary shall consider the least burdensome means of demonstrating substantial equivalence and request information accordingly”.   (The “Secretary” is the Secretary of the Department of Health and Human Resources. The Secretary delegates authority to the FDA Commissioner).

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