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.
Switching over will no doubt be a paperwork burden for some, with the advantage going to bigger companies, who have most of the advantages already. However international harmony is overall a good thing in the regulatory environment, especially when conceptually there isn’t much difference between the QSR and 13485.
A different question is whether the public will be better off. In the early days of the QSR I asked a smart FDAer “Does the QSR result in quality systems which in turn result in quality products? In the spirit of my question the reply was “Thats our position and we are sticking to it”.