Nathan Brown, Howard Sklamberg Pen Article for Medtech Insight on Device Companies and Inspections
“World of Change Coming For Device Manufacturers: Developments In FDA And International Inspections,” an article by Akin Gump health care and life sciences partners Nathan Brown and Howard Sklamberg, has been published by Medtech Insight.
The article discusses opportunities for medical device manufacturers to “leverage several major reforms and initiatives that are getting off the ground related to global facility inspections.” But, they note, firms “must constructively engage with the new programs to reap benefits.”
In the article, the authors—both of whom previously occupied prominent positions at the Food and Drug Administration (FDA)—take a close look at three important initiatives that have been advanced by both the FDA and Congress to improve regulatory efficiency and predictability in the inspection of medical device facilities: the Program Alignment Initiative, the FDA Reauthorization Act of 2017 and the Medical Device Single Audit Program.
They note that these changes, “if implemented effectively, offer device-makers opportunities to streamline and enhance their compliance and quality programs.”
To read the full article, please click here.