The Editor’s Corner: Substantially Equivalent to What?

Harold Alexander

The fundamental aim of section 5 lO(k) of the 1976 Medi- cal Device Amendments to the Food, Drug, and Cosmetic Act was to “grandfather” preexisting medical devices- to exempt them from the newly enacted requirement of undergoing clinical trials. Concurrently, it created a less complicated marketing path for devices that could be shown to be “substantially equivalent” to those marketed before that date. Manufacturers were quick to realize that this route to marketing would be much faster and much less expensive than the standard procedure, written into the same Amendments, which requires filing with the Food and Drug Administration an extensive application (an Investigational Device Exemption, or IDE), providing comprehensive preclinical safety and efficacy data, and submitting a detailed prototcol for clinical trials to prove safety and efficacy in humans-after which a second ap- plication, the Premarket Approval (PMA) application, must be submitted for review by FDA staff and an expert advisory panel, whose conclusions are the basis for a rec- ommendation for approval or disapproval for marketing.

No wonder that over the past 18 years, the 5 10(k) pro- cedure has been so often invoked to introduce new im- plantable products to the marketplace on the basis that they are substantially equivalent to a predicate device. In fact, probably more than 90% of the implant devices in- troduced since 1976 have traveled the 510(k) route. In other words, the vast majority of devices currently in use, having been proclaimed by their manufacturers to repre- sent pre- 1976 technology, have not been subjected to con- trolled clinical testing prior to their introduction. Aside from providing a strong disincentive to developing truly new technologies, this situation has led, in some instances, to the rapid introduction and extensive marketing of un- tested, potentially dangerous medical devices. Not surpris- ingly, some of these “new” devices experience failure rates many times higher than those of their antecedents. We are thus witnessing an era of “improvements” that represent a major step backwards in patient safety and satisfaction. In reaction, aggrieved patients have initiated a flood of lawsuits involving medical devices. This unprecedented litigation threatens the supply of materials for medical de- vices as major suppliers withdraw from the market to avoid future liability.

Medical device manufacturers should have recognized

Journal ofApplied Biornaterials, Vol. 5, 375 (1994) 0 1994 John Wiley & Sons, Inc. CCC 1045-486 1/040375-01

that by introducing new devices via 5 10(k)’s, thus bypass- ing the process of clinical testing, they were risking major, generalized failures. When the defects of such a device are finally detected, it is too late. The device has already been implanted in thousands of people. This process exposes a large population to unnecessary health risks and puts the manufacturer at financial risk in return for a short-term gain.

The field of biomaterials science has progressed consid- erably over the past two decades. We now know that it is impossible for almost any implantable product to be sub- stantially equivalent to another implantable product. Typically, so-called substantially equivalent products vary in mechanical design, bulk material formulation, and/or surface properties. All these characteristics dramatically change biological response to the product. The solution to this dilemma? Eliminate the 5 1 O(k) procedure.

The original purpose of the 5 10(k) procedure was to bridge the gap in the transition from an unregulated to a regulated environment. It long ago outlived this rationale. It should be replaced with a mechanism that allows a man- ufacturer minor changes in currently marketed products. Associated with the requirement that a new implantable device be subjected to the IDE-PMA process are signifi- cant advantages for all concerned. Because controlled clinical testing will be performed before any product is in- troduced into general use, the public will enjoy better pro- tection. The manufacturer, having survived a long and rig- orous approval procedure that will have established a sig- nificant barrier for potential competitors, will effectively hold a regulatory patent-as well as be spared the ridicu- lous position of having to proclaim that its “new high-tech product” incorporates only pre- 1976 technology. Further- more, the manufacturer will possess an effective shield against litigation in the unlikely event of a late device fail- ure, since FDA approval could be used as an argument for federal preemption of liability.

The obvious disadvantage of this suggestion is that it will almost certainly make the introduction of a new de- vice more costly and time-consuming. This writer is con- vinced, however, that this is the only ethical-and, in the long run, cost-effective-alternative. The current state of affairs virtually assures that many devices will be found to be defective after they are in general use. Affected patients will be unnecessarily exposed to potential dangers, and the inevitable suits they bring will significantly damage the economic health of manufacturers and set into motion a decline in our industry that will be to the ultimate detri- ment of us all.

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