As the medical device industry begins to embrace a new era of healthcare collaborations and risk-sharing contracts, what role might FDA play in that trend? This was the question MD+DI posed to a senior advisor to the commissioner of FDA, and his answer might surprise you.
Regulatory and Compliance
The agency ordered a unique type of sales restriction on Essure to make sure women are properly informed of the risks associated with the permanent contraceptive device.
FDA alerted doctors to a problem with the Monteris Medical NeuroBlate probe in which the device may become unexpectedly heated during certain types of brain surgery.
A properly implemented enterprise resource planning system can help keep product timelines in place and manufacturers in compliance.
An expert in quality management systems discusses FDA's Case for Quality pilot program and how it can save companies time and money.
The agency slams all three duodenoscope manufacturers for failure to comply with post-market surveillance requirements to assess contamination risks associated with the devices.
FDA Commissioner Scott Gottlieb updated the public regarding the agency's ongoing post-market review of the controversial birth control device, but patient advocacy group Essure Problems says the commissioner's words are just another letdown.
It might be easier and faster to gain reimbursement in Japan than in the United States, new analysis shows.
Investigators in Indiana treated the first patient in the EVAS2 confirmatory study of the Nellix endovascular aneurysm sealing system. Endologix has had a tough time getting the device through FDA.
Prompted by public outrage over vaginal mesh complications, the U.K.'s health and social care secretary has called for a National Health Service safety audit of the implants, which are used to treat prolapse and female urinary incontinence.
The way FDA analyzes recalls and applies its list of root-cause possibilities needs a dose of transparency.
Early compliance to the European Medical Device Regulation could give medical device manufacturers access to a potential $16.5 billion in revenues across the top 10 EU markets and Switzerland.
Your CAPA process should be entirely risk based, from the moment a request is made until you have verified the effectiveness of the actions taken.