IVD Technology
Magazine
IVDT Article Index
Originally published November, 1998
EDITOR'S PAGE
And another thing . . .
Over the next few months, diagnostics manufacturers will probably be hearing a great deal about design control. And depending on how well they are already complying with that portion of FDA's quality system regulation (QSR), that could be either good or bad news.
As many in industry will recall, FDA's desire to create requirements for design control was one of the motivating elements that led the agency to turn its 1978 good manufacturing practices (GMP) regulation into the 1996 quality system regulation. As embodied in the QSR, the agency's design control requirements follow a pattern already established by ISO 9001, the fullest of the quality systems standards compiled by the International Organization for Standardization. Device manufacturers were to have completed implementation of their design control systems by last June, after a one-year transition period.
From very early in the process of transforming the GMP regulation into the QSR, diagnostics manufacturers asserted that the application of design controls to the creation of IVDs is very different from their use in other sectors of the device industry. And for just as long, they have been asking for a design control guidance specific to IVD manufacturing. These requests were acknowledged last year by Steven Gutman, director of FDA's Division of Clinical Laboratory Devices, when he identified such a guidance as one of his division's priorities for 1998.
The actual work of compiling such a guidance, however, fell to industry. More specifically, that work has been taken up by a subcommittee of the Association of Medical Diagnostics Manufacturers (AMDM) led by Robert James. According to James, a draft of the committee's work is now being circulated for review, and he hopes that it can be readied for publication by the beginning of next year.
Such a schedule could make the guidance a very timely tool, because FDA's Los Angeles District Office is now working with diagnostics manufacturers to develop a January workshop focused on design control and process validation for the IVD industry. Observers indicate that agency inspections have revealed some reason for concern over industry's compliance with design control requirements. Topping the list of Form 483 observations made by the office during 1998 are erroneous or absent design control procedures. As this issue goes to press, details of the planned meeting are sketchy, but updates will be available via the Web site of the Orange County Regulatory Affairs group, at http://www.ocra-dg.org.
The concerns to be addressed by the January meeting are serious ones that could have a forceful impact on the ability of diagnostics manufacturers to do business. Now that the design control requirements are fully and formally implemented, companies that haven't already complied with them won't be given much leeway when it comes time for an FDA inspection.
But companies shouldn't feel that they need to work out the problems of implementing design control by themselves, either. Fortunately, there are a number of IVD-related organizations that can help, as indicated by this year's directory of organizations and associations. Keeping in touch with others in industry is an excellent way for manufacturers to bring themselves up to date on the latest issues, and to avoid falling short in important areas. This year's directory offers a starting point, but it will be up to manufacturers to make the most of their contacts.
Steven Halasey
steve.halasey@cancom.com
