FDA 101 for Medical Devices

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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

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My favorite thing about FDA medical devices is the radiation emitting products applications. Cant wait for IoT...

madmadderson

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.

dareenrose

Where would one find the 510 K for a similar device??

GermanShepherdDaphne

I have doubt, does home use spoon (stainless steel) comes under FDA classification device 1or 2????

Or is considered in FDA classification

jakeshkumar

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?

williamhui

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

mokar

How are you ref happy day We are ultra precision company BAEK YEON thanks.

baekyeonultraprecisionnkl

What ear cleaning products are FDA approved by them .? Recommended

kpa-vopb

I need to no hoo can I talk to if illegal devices or being used on me

TennesseetsychampsGriner

Smart but it's very annoying to hear the lips smacking

sonandpets

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