Auto Injector Medical Device Classification

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Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

Each classification panel in the CFR begins with a list of devices classified in that panel. Each classified device has a 7-digit number associated with it, e.g., 21 CFR 880.2920 - Clinical...

Product Classification - Food and Drug Administration

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=NSC

Product Classification. A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of …

Autoinjector - Wikipedia

https://en.wikipedia.org/wiki/Autoinjector

Guidance for Industry and FDA Staff

https://www.fda.gov/files/about%20fda/published/Technical-Considerations-for-Pen--Jet--and-Related-Injectors-Intended-for-Use-with-Drugs-and-Biological-Products.pdf

Device classification regulation (e.g., 21 CFR 880.5860) and product code (e.g., NSC).10 2. Indication For Use The proposed indication statement should include the following …

510(k) SUMMARY IM Auto-injector Athens, TX 2006 …

https://www.accessdata.fda.gov/cdrh_docs/pdf6/K060389.pdf

Common or Usual Name: Auto Injector Classification Name: Introducer, Syringe Needle Regulation Number: 880.6920 Medical Specialty: General Hospital Product Code: KZH …

The 3 FDA Medical Device Classes …

https://www.qualio.com/blog/fda-medical-device-classes-differences

Classifying your medical device according to one of the 16 specialties is the first step to understanding whether you are manufacturing Class I, II, or III medical …

What are EU MDR classification rules for …

https://advisera.com/13485academy/blog/2021/04/22/mdr-classification-complete-guide/

Three steps for classifying a medical device under the EU MDR To classify your product, follow these steps: Decide what type of device you have: non-invasive, …

MDR Classification: Product - MDR Tool

https://www.mdrtool.com/wp-content/uploads/2017/11/Classification-Rules_b.pdf

– if they may be connected to a class IIa, class IIb or class III active device; or – if they are intended for use for channelling or storing blood or other body liquids or for storing …

Complete Guide: Medical Device …

https://easymedicaldevice.com/new-eu-medical-device-classification/

Let me provide you with some medical device classification examples in Europe for each class: Class I: Wheelchair, otoscope, stethoscope, scalpel, plaster; …

DEVICE REGULATIONS - The New …

https://drug-dev.com/device-regulations-the-new-medical-device-regulation-the-applicability-of-article-117-to-medicinal-products/

Device elements of medicinal products are likely to automatically increase the risk classification due to the presence of the drug product. It should also be considered …

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