Device Companies Agfa, Charter Medical, Cardiogenesis Talk Internal Audits
This article was originally published in The Gray Sheet
Conducting robust internal quality audits is an important way for device manufacturers to ensure they fully comply with FDA regulations.
You may also be interested in...
The proposed rule from the US HHS that would require its agencies to review all regulations every 10 years could distract an incoming Biden administration from the COVID-19 pandemic and will “wreak havoc” on Medicare, a senior policy analyst for the Center on Budget and Policy Priorities says.
The US agency says in the latest update to its medical device shortages guidance doc that it’ll send enforcement missives to companies that don’t notify the agency of a “permanent discontinuance or an interruption in manufacturing” of products deemed critical during the COVID-19 pandemic.
In the only device-related warning letter released by the US FDA this week, Avazo Healthcare was selling two COVID-19 antigen tests without approval, clearance or authorization from the agency.