FDA Updates List of Recognized Standards, Confusion Ensues

On August 6, 2013, FDA published modifications to the list of medical device related standards they recognize. News was made of the fact that additions to the recognized standards addressed areas such as cybersecurity and interoperability. While there were many revisions and some additions of a variety of standards, this blog post will focus on the news making standards related to medical device connectivity. The published modifications are divided between two separate recognition lists, number 31 (pdf) and 32 (pdf). Here is the Federal Register version (PDF). Recognition list number 31 includes one standard under the Software/Informatics category: Laboratory Automation: Data Content for Specimen Identification; Approved Standard (NCCLS AUTO-7A). The 20+ standards listed in recognition list number 32 are all new additions under Software/Informatics and focus on the following topics: IT governance in hospitals for networked medical devices, Medical device connectivity and interoperability, and Cybersecurity These are all great standards (although they are of varying relevance and usefulness). So where is the confusion, you might ask? Reading the stories linked above, this reader was left with the impression that FDA is encouraging or stipulating the use these standards and that by listing these standards, manufacturers can be expected to adopt the new listed standards. Sadly, this is not the case. The intent of listing recognized standards (found in the FDA guidance on the ...
Source: Medical Connectivity Consulting - Category: Technology Consultants Authors: Tags: Standards & Regulatory Source Type: blogs