The FDA Modernization Act: STAYING A NEW COURSE

Medical Device & Diagnostic Industry Magazine
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An MD&DI  January 1998 Column

In addition to improving patient access to needed medical device technologies, the new act may also trigger some changes within the industry.

One topic likely to garner attention in the press in 1998 is the implementation of the FDA Modernization Act of 1997. Opinions regarding the impact this legislation will have on the medical device industry are as varied as the act's provisions themselves.

At the FDLI meeting in Washington, DC, last month, I had the opportunity to speak with representatives from industry, trade associations, FDA itself (particularly CDRH), and congressional staffs to learn their impressions. While some people are calling this law landmark legislation, others say it merely sets in writing what FDA has been working toward the past few years. (And some more cynical folks maintain FDA started its reengineering efforts only in response to industry demands and to curtail more radical legislation regulating its work.)

Heralded as the first major reform of FDA in decades, the FDA Modernization Act is expected to improve patient access to needed medical device technologies by making important changes in the ways new products come to market, by streamlining some of the agency's existing postmarket controls, and by taking steps to recognize standards developed by other national or international standards-

development organizations. Trade groups are among those projecting that the reforms to the 510(k) review process will encourage new small companies as well as companies developing high-risk devices to enter the medical device industry.

Trade associations also are hailing the reforms in the premarket approval (PMA) process. Manufacturers now have the statutory right to meet with FDA before clinical trials begin so they can agree on the clinical protocol, investigational plan, and any use of historical data. In addition, FDA must meet with the product sponsor not later than 100 days into the PMA review process to discuss any deficiencies, and to request any additional information required for approval while considering the "least burdensome" means of demonstrating the product's effectiveness.

Much depends on how FDA interprets and implements the new law. While past laws have languished for up to 10 years before being implemented, FDA claims those days are long gone.

So what does the future hold? Congressional staffers instrumental in passing this new law say Congress now has a better understanding of the needs and resulting laws that should regulate the medical device as opposed to the pharmaceutical industry. But Congress is concerned that the new act may overburden an already-loaded organization. Some insiders guess that we'll see more legislation within the next five years expanding the scope of third-party audits and continuing to fine-tune the agency's role.

Change is in the air at Canon Communications as well. John Bethune, previously the editor of MD&DI, will continue to direct the editorial of all Canon magazines (now numbering eight with the recent acquisition of Pharmaceutical & Medical Packaging News) as well as focus more on other corporate business. I've spent my first few weeks at MD&DI meeting readers, touring manufacturing operations, and learning about the challenges of your daily worklives.

Tell me what you think (about the FDA Modernization Act and other concerns) by either dropping me an E-mail or calling me at 310/392-5509. I'd like to hear from you!

Stacey L. Bell

[email protected]

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