FDA releases long-awaited GMPs for medical devices

Agency avoids rules covering refurbishers and ISOs

The manufacturers of medical devices will be held to a higherstandard for both the manufacturing and servicing of their productsstarting June 1, 1997. On that date, the Food and Drug Administration'srevised Good Manufacturing Practices will take effect, imposingstrict new requirements to control the design of devices, as wellas their manufacture, packaging, labeling, storing, installing,and servicing.

The revised GMPs, which are part of a comprehensive new qualitysystem regulation released by the FDA, dictate that manufacturersestablish performance requirements for devices before production;ensure that device components are compatible with each other;select adequate packaging materials; and, where appropriate, dorisk analyses.

The intent of the revised GMPs is to bring U.S. requirementsin line with quality system regulations worldwide. Some companies,such as ADAC Laboratories of Milpitas, CA, got ahead of the gameby reorganizing operations to comply with the ISO 9000 internationalstandard, upon which many provisions in the new GMPs are based.

"We believe we will be substantially compliant with thenew GMPs, but there will obviously be a few things yet to do,"said Doug Keare, vice president of quality at ADAC. "We'rein the process of looking at the final rule and we don't havethe final list (of points not yet addressed)."

ADAC's jump on becoming GMP-compliant is just a side benefitof the process the company has instilled in its development andmanufacturing operations. Quality programs have become a cornerstoneof product development and manufacturing at ADAC, which last monthbecame the first healthcare company to win the Malcolm BaldrigeNational Quality Award (SCAN 10/23/96).

Several other major OEMs of imaging equipment, including GEand Siemens, have taken similar steps toward quality, becomingISO 9000-compliant and thereby getting a jump on the new GMPs.

Recognizing, however, that not all companies have done so,the FDA is phasing in the new requirements. And, in an unusualshow of empathy for the industry, the agency has decided to deferenforcement of violations found during the first 12 months inregard to design controls. This transition period is intendedto allow time for both industry and FDA field investigators tobecome familiar with the design-control requirements, as wellas the enforcement aspects of this new area, according to sourcesat the FDA.

The agency also intends to review the results of design controlinspections conducted from June 1 through Dec. 1, 1997, to determinewhether changes need to be made in the way the GMPs are beinginterpreted in the field. Any mid-course adjustments to the inspectionstrategy will be instituted and made public by spring 1998. TheFDA will also evaluate whether design-control requirements writteninto the final rule are appropriate. If not, minor or even majorchanges will be considered, according to FDA sources.

Agency officials have already side-stepped the biggest sourceof controversy: how to address independent service organizationsand refurbishers. This point has caused concern during the lastseveral years. The FDA wanted to regulate all service done onmedical devices, but doing so would have forced small businesses,such as ISOs and refurbishers, to install quality systems thatcould have created untenable financial burdens. Just as stickywere concerns raised about regulating hospital biomedical staff,who service in-house medical equipment.

"When the president of HIMA (Health Industry ManufacturersAssociation) and at least a dozen representatives of new equipmentmanufacturers rose in the August 1995 FDA meeting to ask the agencyto `level the playing field' with the secondary market -- toldthe FDA that only the original manufacturer could properly service,recondition, or refurbish equipment -- they were not doing thisto insure the prosperity of our industry," said Gregory Weiner,vice president and chairman of the Legislative Action Committeeat the International Association of Medical Equipment Remarketers."They knew that saddling our industry with the GMP burdenwould have a positive competitive effect on their own businesses."

But independent refurbishers and ISOs dodged that bullet. Thefinal rule does not apply to them, unless they are engaged in"remanufacturing," defined by the FDA as "any personwho processes, conditions, renovates, repackages, restores, ordoes any act to a finished device that significantly changes thefinished device's performance or safety specifications or intendeduse." Since remanufacturers were covered under the previousGMPs, the revision does not represent a change in policy, accordingto Weiner.

The regulation does, however, hold OEMs responsible for complyingwith GMPs in any and all service functions that they perform.ADAC's Keare believes that the exemption does not give ISOs andrefurbishers long-term advantages.

"My sense is that the FDA will be developing new guidelinesso as to create a level playing field," he said.

Sources at the FDA indicate that the agency plans to addressservice and refurbishing activities by companies and groups otherthan OEMs in a separate rule to be released before the end ofthis year. That action was expected, according to Weiner.

"It was reasonably clear from the discussions that tookplace at the recent (1995) meeting that the FDA was not readyto simply forget we all exist," he said.