Part 11 tricky for device firms; no reprieve offered.

Compliance with Part 11 appears to be a struggle for many medical device companies, at least those attending recent meetings of the Food & Drug Law Institute (FDLI) and Medical Device Manufacturers Assn. (MDMA).

It also is a struggle for FDA, which is still in the process of making its own computers compliant with the regulations.

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Stewart Crumpler, a software expert at FDA's Center for Devices, who spoke at both FDLI and MDMA meetings last month, said the agency expects companies to have in place already the procedural and administrative compliance requirements of Part 11, but it is allowing more time to implement the more expensive technical controls.

The agency has not put a time limit on when medical device manufacturers must have technical controls in place.

"I suspect there is quite a large number of firms that are not Part 11 compliant," Crumpler said, despite the fact that the rule was enacted in August, 1997.