AdvaMed Wants Changes in Software Guidance
AdvaMed says that while it supports development of guidance by both FDA and the International Medical Device Regulators Forum (IMDRF) to help companies understand when clinical evaluation may be needed to demonstrate a reasonable assurance of safety and effectiveness for software intended for one or more medical purposes without being part of a hardware medical device, significant revisions are needed in a draft guidance if the purpose is to be achieved. In a comment letter, the trade group raises many concerns, starting with the fact that the draft uses terminology that has specific meanings in the European Union or concepts that are specific to FDA approaches to regulating products, which do not translate across jurisdictions.
The letter also says the document “includes a significant amount of redundant information, making it difficult to understand. Unless this issue is resolved, it will be difficult for regulatory authorities to translate the requirements into ordinances, regulations, or guidance documents that align with local requirements. It also casts doubt on the ability of manufacturers to use it correctly in classifying software as a medical device in the appropriate category.”
While understanding and generally agreeing with FDA’s desire for global harmonization, AdvaMed says, it does not believe that wholesale adoption of a global guidelines document that does not comport with existing U.S. law is the way to do it. It calls on FDA to issue guidances to address, among others, the many issues raised by the association in its letter and to align and conform terms and definitions, the product classification system, the review standard, postmarket requirements, and the new 21st Century Cures legislation with those used in the Federal Food, Drug, and Cosmetic Act.
In its letter, the 510(k) Coalition says it is pleased to see work done on the topic, but is concerned about the process used to create the draft. “We feel this draft guidance is not appropriately following the standard and traditional processes required for creation of guidance documents via the good guidance practices process set forth in the U.S. regulatory system,” it says. “The process for creating IMDRF documents may not provide for sufficient input from U.S. stakeholders and does not meet good guidance practices that FDA strives to use…. While IMDRF may well serve an important process, we believe that before an IMDRF document can be transformed into a U.S. guidance document, it needs to be put through good guidance practices. This could include public meetings, inclusion in regulatory agendas, and greater input into the content…. Otherwise the current process does not allow for effective or meaningful input from a variety of stakeholders.”
Finally, AstraZeneca says that although the guidance includes within its scope SaMD systems that are used to treat a disease or condition, it appears to provide more content and examples for diagnostic SaMD. Additional detail and examples should be provided for treatment SaMD systems, it says.