Autoinjector Medical Device Classification

Classify Your Medical Device | FDA

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

Classify Your Medical Device. The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical ...

Product Code Classification Database | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database

The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892. These files are updated every …

Overview of Medical Device Classification and …

https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-device-classification-and-reclassification

Reclassification of Medical Devices. A preamendments device is one that was in commercial distribution before May 28, 1976, the date the Medical Device Amendments …

Medical Device Classification Product Codes …

https://www.fda.gov/media/82781/download

The scope of this document includes devices described in the existing classifications under 21 CFR Parts 862-892. It also describes how the product code …

Autoinjector - Wikipedia

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

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

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

Classification Name: Introducer, Syringe Needle Regulation Number: 880.6920 Medical Specialty: General Hospital Product Code: KZH Device Class: Class II Predicate …

SHL MEDICAL - Food and Drug Administration

https://www.accessdata.fda.gov/cdrh_docs/pdf6/K060141.pdf

Classification Name: Syringe Needle Introducer 3. Device to which substantial equivalence is claimed Device Name: SHL Medical, USA Disposable Autoinjector "DAI" 510(k) …

MDR Classification: Product - MDR Tool

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

Yes: ☐ Class IIb In all other cases such devices are classified as class I. Yes: ☐ Class I a8_004_3 Rule 3 All non-invasive devices intended for modifying the biological or …

A CHECKLIST FOR AUTOINJECTOR DESIGN - ONdrugDelivery

https://ondrugdelivery.com/a-checklist-for-autoinjector-design/

In 2021, the global subcutaneous drug delivery devices market was estimated to be worth US$25.53 billion (£19.46 billion) and is expected to grow to more …

Complete Guide: Medical Device …

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

The Medical Device Classification EU rules, which are based on the vulnerability of the human body, should take into account the potential risks associated …