Seeking to render the FDA’s Feb. 2011 rule on medical device data systems (MDDS) in user-friendly language, the Association for the Advancement of Medical Instrumentation (AAMI) has crafted a new guide.
The association introduced a pre-publication version of the document, AAMI SW87, at a conference convened jointly with FDA in Herndon, Va., March 21-22.
Under the rule, any hospital or healthcare provider that modifies an MDDS can be considered a manufacturer. As such, it would be subject to the relevant regulations and required to adopt a quality assurance system by April 18.
AAMI said in a news release that it expects to publish its guide by mid-April, pointing out that the document will be aimed at MDDS newcomers.
“We are still at the stage of outreach,” said John Murray, FDA medical device software compliance expert and co-chair of AAMI’s medical software committee, which developed the document. “There are a lot of folks that haven’t heard of MDDS or quality system regulations.”
He told conference attendees that between 90 and 100 entities have so far registered with FDA as MDDS manufacturers, four of which are hospitals.
Murray also said no hospital inspections are planned and that FDA has set no specific MDDS compliance policy.
AAMI did not specify in what form it will publish its guide or how to obtain a copy.
FDA has posted resources to help with identifying an MDDS and complying with the MDDS rule.