FDA Virtual Inspections Might Endanger Americans
Do FDA “Virtual” Inspections of Domestic and Foreign Manufacturing Sites Endanger Americans? As the Covid-19 Pandemic Rages On, FDA is Issuing a Pilot Program for “Virtual” Inspections of Domestic and Foreign Manufacturing Sites UNITED STATES – According to medtech.pharmaintelligence.informa.com, the global pandemic is … [Read more...]
New Federal Law May Grant the FDA the Power to Recall Dangerous Drugs
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) is one step closer to receiving authority to order drug and medical device recalls. According to raps.org, the U.S. House of Representatives Committee on Appropriations voted to approve the FDA’s $3.212 billion budget that not only funds the agency for 2021 but also takes … [Read more...]
FDA to End Alternate Summary Reporting Program
WASHINGTON D.C. — An article from CNN revealed that Medtronic’s Sprint Fidelis cardiac pacemaker and tens of thousands of other devices are exempt from public scrutiny because the FDA would permit medical device manufacturers to file summary reports of malfunctions rather than file full reports that would be made public by the … [Read more...]
FDA Recalls Medtronic Heart Pump Calling it Life-Threatening
Defective Medtronic Heart Pump Is Taking Lives? Medtronic Life-Threatening Heart Devices. The Medtronic heart pump is an HVAD System which takes over for a failing heart. Basically, the system helps to support individuals with heart diseases while they wait for a heart transplant. Flaws, however, surfaced with the heart device … [Read more...]
