Question
FDA has an agreement with EPA where low-level disinfectants used in areas like hospital rooms are regulated by EPA. A client has a low-level EPA-approved disinfectant cleared to inhibit microbial growth on the surface to which it is applied. But rece...
Hi all, I was wondering if anyone had much experience with the safety and performance guidance that came in at the start of Feb? I was trying to find the list of eligible device types but have had no luck as yet.
Mike Drues is one of the most gifted regulatory people I know. At 10x he said, If you're going to change a medical device in an administrative way, you have two options to handle that. • You notify the FDA (and if you do, how?); or, • You don't notif...
Danny Kroo
ISO 13485 medical device, AS9100, AS9120 aerospace and ISO 9001 QMS consultant & lead assessor QA/RA Manager at Montmed
January 2019
A company is interested in getting a private label agreement with an OEM to sell a Class II medical device in the USA. The OEM has 510(k) clearance and the only product change will be the company's name on the label. There will be no change for the i...
Simply a gift for you today. If you have anything to do with medical device quality systems, click here for FDA slides for immediate download. Four slides that stood out to me It was hard to narrow down the four hours from four presentations to four ...
I know a guy who got a $500,000 grant to make FDA data easier to search. As it neared completion, it was scuttled by two employees whose jobs would be jeopardized. Infuriating. So the answer to "which is the most frustrating FDA database" is probably...
I've been hosting 10x Medical Device Conferences for six years but no one – before Bob Marshall – sang on stage. You likely recognize Bob's name if you subscribe to his extremely popular Med Device Online site where he serves as Editor in Chief. I ci...
I'm new to my orthopedic implants and associated instrument company and inherited a 510(k) in review. In this 510(k) and those cleared in the last year, we had no discussion on usability 62366-1. We also didn't discuss evidence for biocompatibility b...
Long-time readers won't be surprised that my dear friend, regulatory expert Robert Packard is offering to teach an FDA pre-submission workshop for free. In fact, the last time we held this workshop – some 3½ years ago – more than 1,500 members regist...
From the looks of things, pretty big. If you tuned into the first of FDA’s Case for Quality webinars, you learned about FDA’s shift their from 'compliance with regulations' to 'device quality.' Get the replay and register for part two at https://medg...
