In a blog post, U.S. FDA Commissioner Scott Gottlieb revealed that the agency is taking steps to “modernize medical device regulation, by proposing a new regulation to replace certain aspects of existing Quality System regulations (21 CFR 820) with specifications of an international consensus standard for medical device manufactures (ISO).”
Gottlieb said the rule, if finalized, will synchronize U.S. and global requirements and adjust the regulation to make it “more efficient” for medical device manufacturers to market their products abroad. At the same time, Gottlieb maintained, the finalized regulation will make sure those who manufacture medical equipment adhere to “high-internationally-accepted quality systems.”
Joe Lewelling, AAMI’s vice president of emerging technologies and health IT, addressed Gottlieb’s blog post in a separate statement posted on AAMI’s website. “AAMI,” Lewelling said, “is working with industry stakeholders and other organizations, such as the Medical Imaging & Technology Alliance, AdvaMed, and the Medical Device Manufacturers Association, to minimize the hurdles that medical device manufacturers, especially smaller companies, will face during the transition from the Quality System Regulation to regulatory use of 13485.”
What are your reactions to Gottlieb’s announcement, however? Do you believe the FDA’s proposed move will affect the medical device sector negatively or positively? Please share your thoughts in the comments section below.