Software Coalition To FDA: Revamp Guidance Approach By Using Advisory Opinions

The Clinical Decision Support Coalition says FDA's guidance document approach hasn't kept pace with innovation and calls for the use of narrowly crafted advisory opinions to answer industry questions on regulation of new technology. The group cites the lack of guidance on clinical decision support software as an example of how the traditional guidance process is broken. “We think FDA should develop a new, additional approach to guidance beyond the traditional lengthy and comprehensive guidance document that covers an entire...