The Food and Drug Administration wants to revise the good manufacturing practices (GMP) regulations in the U.S., calling them out of step with European quality assurance standards. The National Electrical Manufacturers of America has proposed an alternative. Rather than rewrite existing rules, why not just adopt the European standards?
"NEMA is concerned that the FDA's proposed changes to the medical device GMP greatly exceed the requirements of European quality assurance," said Robin Wiley, NEMA spokesperson. Rather than fight over the proposed changes, NEMA has focused on the stated goal of the FDA: to bring rules in this country into harmony with those in Europe.
"(Adopting the standard) would pave the way for GMP inspection and certification agreements with the European Community," said Robert Britain, director of the NEMA diagnostic imaging and therapy systems division. "Since Canada has proposed that its GMP will be based on ISO 9001, (the same) would also be possible with Canada," Britain wrote in a Feb. 28 letter to the FDA.
NEMA has taken the position that its proposal is consistent with the Congressional establishment of an office of international relations within the FDA. The office is supposed to facilitate mutual recognition of quality assurance standards among countries, according to Wiley.
