Quality becomes FDA priority

January 16, 1991

The marketing buzzword of the `80s is on its way to becoming theregulatory watchword of the `90s. The Food and Drug Administrationhas decided that many of the agency's headaches--and those ofindustry--would disappear if company executives were more

The marketing buzzword of the `80s is on its way to becoming theregulatory watchword of the `90s. The Food and Drug Administrationhas decided that many of the agency's headaches--and those ofindustry--would disappear if company executives were more committedto quality.

"Over the years a number of regulatory actions could havebeen avoided if upper management had been more involved, had oversightof a quality assurance program and had provided some feedback,"said W. Fred Hooten, director of the division of compliance programsin the FDA Center for Devices and Radiological Health. "Weare trying to achieve recognition by upper management of the needfor the quality program and the importance of their participationin it."

What troubles industry is that the agency wants to do morethan just remind executives of the need for quality. FDA officialswould like to require management to consider quality as part ofthe good manufacturing practices (GMP), and delegate top managersto implement and maintain a quality control system.

The agency is hashing over these and other quality issues aspart of an effort to include design validation as a mandatorycomponent of GMP. Other issues include making companies responsiblefor tracking the safety and effectiveness of devices and the serviceperformed on them.

"Industry anticipates seeing design validation includedas part of the requirements in Europe. Our major concern aboutthe medical device bill that just passed is that design validationin the U.S. be voluntary rather than mandatory," said RobinWiley, a spokesperson for the National Electrical ManufacturersAssociation (NEMA) in Washington, DC. The European system thatwill be adopted as part of EC 92 will be voluntary, Wiley noted.

NEMA members serving on the association's GMP advisory committeemet Jan. 10 to discuss the proposed changes, which were publishedlast month in the Federal Register, the official mouthpiece ofthe federal government.

The idea behind the NEMA meeting was to discuss possible consequencesof the proposed changes and prepare a response before the FDA'sGMP meeting, scheduled for spring. The FDA committee, which lastmet in June 1990, must sign off on the changes if they are tobe enacted.

Design controls, specifically procedures that ensure qualitythroughout the preproduction stage, are among the specifics theagency would like to see included in the GMP. Holding managementresponsible for quality assurance is necessary to establish afirm commitment to quality throughout the corporation, Hootensaid.

ALTHOUGH DEVICE SAFETY AND EFFECTIVENESS issues are at the rootof the FDA's quality concerns, there is more at stake in the government'stinkering with corporate management and policy. Global harmonywould also be served, according to Hooten.

"While design validation is new in that it hasn't beena part of the GMP in the past, it has been a part of the ISO 9000quality standard, which will be adopted by the European Community,"he said.

The FDA is trying to focus industry's attention on Europe andthe need to include design validation in the GMP to remain insynch. "EC 92 is helping the FDA sell the issue to industry,"Wiley said. "But I think they have wanted to include qualityassurance in design for a long time."

Many of the initiatives contained in the new GMP proposal areat least implied, if not explicitly stated, in the new medicaldevice legislation that President Bush signed into law late lastyear (SCAN 11/7/90).

Questions have been raised, however, about the agency's abilityto implement the new mandate from Congress or new directives fromits own top brass. Some of those questions revolve around thesketchy details that have been provided to industry about howthe new initiatives would be implemented. There are no clear-cutprovisions about how design would be assessed, for example.

"Does design validation mean looking at the process ofdesign or at the actual design of a product?" Wiley asked."That is one of the gray areas that needs to be clarified."

Another such area is the proposal that companies be held responsiblefor tracking the safety and effectiveness of devices after theyenter the marketplace.

"Folks are afraid this could lead local FDA inspectorsto go on fishing expeditions through a manufacturer's files,"Wiley said.

Wiley and her colleagues at NEMA hope to come up with solutionsto these concerns and convey them--as advice--to the FDA in thecoming months.