FDA 101 for Medical Devices

  Рет қаралды 35,861

Registrar Corp

Registrar Corp

Күн бұрын

Registrar Corp's webinar provides industry with important information regarding U.S. FDA regulation of medical devices, including:
- Annual Registration Renewal
- eMDR Requirements for Adverse Events
- Unique Device Identifier (UDI) Requirements

Пікірлер: 15
@madmadderson7318
@madmadderson7318 3 жыл бұрын
My favorite thing about FDA medical devices is the radiation emitting products applications. Cant wait for IoT...
@rajendrasheregar3113
@rajendrasheregar3113 3 жыл бұрын
continue--->
@madmadderson7318
@madmadderson7318 3 жыл бұрын
Meh. Not my problem.
@jakeshkumar
@jakeshkumar 4 жыл бұрын
I have doubt , does home use spoon (stainless steel) comes under FDA classification device 1or 2???? Or is considered in FDA classification
@GermanShepherdDaphne
@GermanShepherdDaphne 3 жыл бұрын
Where would one find the 510 K for a similar device??
@dareenrose6550
@dareenrose6550 2 жыл бұрын
Thanks for the video, I have using NightRider cgm and Libre sensor for monitor the glucose values on phone without scanning and finger prick. Also, I share glucose data as well as my food insights, activity data to my endo. I found all these features are very useful.
@williamhui6195
@williamhui6195 2 жыл бұрын
We found our N95 respirator can be registered as FDA product code MSH in FDA database with no 510(k) is needed. Once we got the establishment number issued by FDA, we can only use FDA registered for our N95 respirator. However, why we cannot declare our N95 respirators as FDA cleared? How should we do if we want to be FDA cleared eventually?
@kpa-vo4pb
@kpa-vo4pb 4 жыл бұрын
What ear cleaning products are FDA approved by them .? Recommended
@baekyeonultraprecisionnkl9574
@baekyeonultraprecisionnkl9574 3 жыл бұрын
How are you ref happy day We are ultra precision company BAEK YEON thanks.
@TennesseetsychampsGriner
@TennesseetsychampsGriner 5 жыл бұрын
I need to no hoo can I talk to if illegal devices or being used on me
@GermanShepherdDaphne
@GermanShepherdDaphne 3 жыл бұрын
It's hard to understand
@mokar0873
@mokar0873 5 жыл бұрын
Are these items considered as medical device? Dental resins 3D scanners for dental laboratories 3D printers Milling machines? How de classify them Thank you so much
@GermanShepherdDaphne
@GermanShepherdDaphne 3 жыл бұрын
Dental adhesive
@sonandpets1215
@sonandpets1215 2 жыл бұрын
Smart but it's very annoying to hear the lips smacking
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