Software Regulation for Patient Safety: Easing the Burdens of FDA and Industry

Originally Published MDDI August 2001

Editor's Page

Software regulation for patient safety: Easing the Burdens of FDA and Industry

The challenge facing the agency and industry alike is to develop a standard that allows for timely premarket review while still adhering to risk-based review criteria.

The need for effective regulation of medical software is clear. But devising a strategy for protecting consumers from software-related device failures without impeding the process of innovation poses significant challenges.

Today's software often becomes obsolete in six months or less. This can be a critical issue for the medical device industry, where lengthy review times by CDRH can delay the release of new products. The difficulty is to design a system that would provide timely premarket reviews of medical device software, use risk-based review criteria, and keep pace with the evolution of the software used in medical devices.

Sherman Eagles, technical fellow at Medtronic Inc., and John Murray, software expert with CDRH, have proposed one solution. If a manufacturer can demonstrate that device software has been "developed using good software engineering practices," questions concerning the development process can be eliminated, speeding up the review process. They argue that the role of software standards is "to precisely document and define what constitutes good software engineering practices."

Efforts to develop appropriate standards for medical device software have now spanned more than six years. Two important milestones, however, were passed this year: in March, the AAMI board approved a standard developed specifically for medical devices, and the document was approved by ANSI on June 5.

The next step will be to gain FDA recognition of the ANSI/AAMI SW 68—Medical Device Software—Software Lifecycle. At a meeting of the AAMI Medical Device Software Committee on June 28, it was noted that a letter from AAMI has been drafted requesting FDA recognition of the standard. An FDA recognition document could be published as early as November 2001.

During the recent AAMI/FDA International Conference on Medical Device Standards and Regulation, there appeared to be clear indications that FDA will recognize SW 68. It was also apparent that such action would do much to ease the agency's current premarket burdens. A fundamental problem for FDA has been the sheer volume of software to be reviewed. "We need a better way to do business," Murray says. "The FDA strongly believes that through the use of standards we can reach consensus and find a better way."

What remains to be done? SW 68 applies to low- and moderate-risk stand-alone and embedded medical software systems. The next challenge will be to identify or create standards that will apply to all remaining medical software, including high-risk systems. In addition, initial steps have already been taken to develop a new international standard—a process that could be completed by 2004.

Development of medical software standards represents an effort to gain control of a technology that is growing and changing with alarming speed. The standard will likely prove a valuable tool for easing the burdens of industry and FDA alike. Our hope is that recognition by the agency will occur quickly and that efforts to develop an international standard will be successful.

The Editors

Copyright ©2001 Medical Device & Diagnostic Industry