Hospitals aren’t the only ones that are moving to electronic records. Manufacturers face that change, too, and they need to prepare to submit their medical device applications to regulators electronically, standards experts say.
“The message here is that e-submissions are coming,” said Bernie Liebler, director of technology and regulatory affairs for Advanced Medical Technology Association (AdvaMed), a Washington, DC-based trade group representing device manufacturers. “The pharmaceutical industry is pushing for e-submission standards that can also be used for devices.”
The healthcare informatics standards organization Health Level Seven International (HL7) is creating such a standard, one that will include guidelines on how to submit applications electronically for regulated drugs and medical devices to authorities around the world.
Liebler, who spoke during a May 23 webinar sponsored by AdvaMed on e-submissions, called for the formation of an international working group of device manufacturers to help develop the standard.
For more information please click here: AAMI News: E-Submissions Coming for Manufacturers
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