Medical device manufacturers know that the FDA can inspect their establishment any time,
Topics: Form 483, Medical Device Manufacturers, FDA
You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
Medical device manufacturers know that the FDA can inspect their establishment any time,
Topics: Form 483, Medical Device Manufacturers, FDA
Thanks in large part to innovation in the medical device industry, the average human lifespan has nearly doubled in the past hundred years. Medical devices have undoubtedly improved the quality of life for millions of people, too.
But a provocative new Netflix documentary raises an important question: Is there a point when innovation goes too far?
"The Bleeding Edge," produced by Academy-Award nominated filmmakers Kirby Dick and Amy Ziering, tells the stories of patients who say they’ve suffered serious health problems as a result of recent medical devices being used in their procedures.
Topics: Medical Device Manufacturers
Why in 2013 was there
Topics: Medical Device Manufacturers, FDA, CDRH, Product Recalls
On February 7th, China FDA released the finalized Special Review and Approval Procedure for innovative Medical Devices. It allows both domestic and international manufactures to apply for accelerated approval.
Topics: Medical Device Manufacturers, China FDA, Fast-track Review
The former FDA Commissioner Dr. Andrew von Eschenbach has made bold statements in the past, and it once again publically stating his recommendations for the Agency. Previously he argued that efficacy should be removed from the initial FDA approval process, so FDA can focus solely on safety. He believed this would help medical device manufacturers introduce products to market faster and provide quicker access to patients on novel therapies.
Topics: Medical Device Manufacturers, Faster FDA Device Approvals, Dr. Andrew von Eschenbach