Paul Rogers for food and drug law matters; Rod Munsey, representing the Pharmaceutical Manufacturers Association; and Hutt, representing FDA, then spent 2 months totally rewriting the statute. At the time, Hutt noted, 13 trade associations represented the medical device industry and requested an opportunity for input; these ultimately assembled into what is now the Advanced Medical Technology Association, or AdvaMed.

In the draft that would become the MDA, the issue of classification was separated from the issue of how a device gets to market. Hutt noted that calling this the 510(k) process is something of a misnomer in that it is actually Section 513 of the Federal Food, Drug, and Cosmetic Act that requires FDA to classify medical devices as class I, II, or III on the basis of potential risks and benefits. Section 510(k) was written as a reporting obligation. FDA had no authority to approve a 510(k) submission. Until 1990, when the law was changed, a manufacturer merely submitted a 510(k) report to FDA and placed its product on the market. The original objective was for FDA to have knowledge of all devices on the market so the Agency could prioritize and determine the appropriate classification and requirements.

The legislation stated that a postamendment device could be marketed if it was not “significantly different” from an existing device. There were no deadlines in the standard provisions for devices that needed to be approved and no time limit for FDA to review preamendment devices. That gave discretion to FDA throughout the statute by using general terms. A banned-device provision was included to ensure FDA’s authority to put a notice in the Federal Register and remove a product from the market. There is adequate authority for FDA to require reports from the industry about adverse events resulting from use of their devices. (In response to a committee question, Hutt added that although it was not feasible then, it would be realistic now to set up a broad national system that would link databases of institutions that use medical devices.) The drafters’ intent was that FDA would actively set priorities and potentially revise what was considered a reasonable model for substantial equivalence as it went along rather than necessarily becoming passive and allowing things to continue with no end in sight.

After the bill was introduced in March 1973, it was decided that not significantly different was not ideal, and substantially equivalent was included in the final legislation. The MDA was enacted in 1976.



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