NEMA tries to derail GMP revision

The Food and Drug Administration wants to revise the good manufacturingpractices (GMP) regulations in the U.S., calling them out of stepwith European quality assurance standards. The National ElectricalManufacturers of America has proposed an alternative. Rather thanrewrite existing rules, why not just adopt the European standards?

"NEMA is concerned that the FDA's proposed changes tothe medical device GMP greatly exceed the requirements of Europeanquality assurance," said Robin Wiley, NEMA spokesperson.Rather than fight over the proposed changes, NEMA has focusedon the stated goal of the FDA: to bring rules in this countryinto harmony with those in Europe.

"(Adopting the standard) would pave the way for GMP inspectionand certification agreements with the European Community,"said Robert Britain, director of the NEMA diagnostic imaging andtherapy systems division. "Since Canada has proposed thatits GMP will be based on ISO 9001, (the same) would also be possiblewith Canada," Britain wrote in a Feb. 28 letter to the FDA.

NEMA has taken the position that its proposal is consistentwith the Congressional establishment of an office of internationalrelations within the FDA. The office is supposed to facilitatemutual recognition of quality assurance standards among countries,according to Wiley.