Originally published February, 1997
Many manufacturers are not hesitating to begin following FDA's new quality system regulation. A recent survey of the medical device industry in Minnesota by Medical Alley (Minneapolis) found that 9 out of 10 respondents have already started to bring their procedures in line with the new requirements. On the survey, which had a response rate of about 30%, nearly half of the respondents reported being near to completion of their efforts to comply, and 16% said that they have actually completed this process. The standards will require ISO 9000 record-keeping systems, and half of the respondents reported that they were already ISO 9000 certified.
The regulation does not come into effect until June 1, 1997, and the design control provisions will not be enforced until after June 1998. According to this survey, many companies will be ready to meet these new standards. Three-fourths of respondents also reported they felt the timetable for compliance was acceptable.
Tom Meskan, the president of Medical Alley, says, "We weren't sure what to expect from this survey, and it was interesting to see that such a large percentage of manufacturers were already getting started meeting the requirements." According to Meskan, however, the most important result of the survey was that it provided the opportunity for a useful interchange between FDA and industry. Meskan says that the association plans to conduct future surveys of industry on this issue.
Medical Alley, with 230 members from medical device companies, hospitals, clinics, health plans, research facilities, and other groups interested in regulatory issues, also plans to continue its efforts to communicate with FDA. The survey results were announced last November 14 at a joint meeting of Medical Alley and the Minneapolis district office of FDA.--Leslie Laine