Key words: design control, quality system, harmonization, tech support
In FY 97, OST continued to support the multi-year effort to implement the new Quality System Regulation, particularly the section regarding Design Controls. The Quality System Regulation was published in the Federal Register on October 7, 1996, and became effective on June 1, 1997.
The Medical Electronics Branch within OST has long been at the forefront of efforts to focus regulatory attention on design issues in electronic medical systems and medical device software. Design controls, a new authority which CDRH received as a result of the Safe Medical Device Act of 1990, provide a sound legislative basis for focusing on design issues. The new Quality System Regulation provided the vehicle for implementing the design control authority, and as such, represented a substantial departure from "business as usual" for the Agency.
The Medical Electronics Branch (MEB) led a Center-wide team in drafting guidance for manufacturers to assist them in understanding and complying with the design control requirements in the regulation. The draft guidance was published in March 1996. Based on industry response, it was substantially rewritten by MEB staff to make it less prescriptive and to allow manufacturers greater flexibility in implementing design controls. Following review by the Center-wide team to assure that all industry comments had been adequately addressed, the final draft guidance was submitted to the Global Harmonization Task Force, Study Group 3 in the autumn of 1996. MEB team leaders negotiated a consensus guidance document with the Study Group, which was published by FDA in final form in March 1997.* Since its release, the guidance has been very well received by industry and helped contribute to what has been widely regarded as the most successful roll-out of a new regulation in recent FDA history.
Although the Design Control Guidance document has been published in "final" form, FDA is interested in hearing from interested parties who wish to suggest revisions to the document. OST will continue to develop guidance on related topics, including software safety, dependability, and risk management.
*The guidance document is available at http://www.fda.gov/cdrh/dsma/cgmphome.html.