Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines

J

jmlbell

#1
I am trying to find guidelines regarding biologic injectable device clinical trial packaging/artwork/labeling for the US.

I can see FDA guidelines for commercialised product but not for clinical trials.

Can anyone help me?

All the best,

jmlbell
 
Last edited by a moderator:
Elsmar Forum Sponsor

Ronen E

Problem Solver
Leader
Moderator
#2
:confused:

You are writing about an "injectable device" but have posted in the pharmaceuticals regulation forum. Is it a medical device or something else? If a device, are you referring to the injector or to its contents?

Welcome to Elsmar's discussions :bigwave:
 
J

jmlbell

#3
Thanks Ronen,

In Europe a biologics injectable device is regulated as a pharmaceutical medicine rather than a medical device so that is why I posted here. I am talking about a biologic medical device-pharmaceutical medicine combination product.

I have come across the following from the FDA:

How is a product classified if it meets the definitions for both drug and device, and might also meet the definition for biological product?(I am unable to post the web link at this time)

I am specifically interested in the approach to get the biologic device through clinical trials in the US. I am able to find information on commercialised product but nothing substantial on investigational medicinal product.

Can anyone help?
 
Last edited by a moderator:

Ronen E

Problem Solver
Leader
Moderator
#4
Thanks for trying to clarify. Perhaps it's just me, but I'm still not sure what exact product we are discussing.

Are we discussing a combination device, consisting of some injector that is offered for use pre-filled with (or pre-loaded with a cartridge of) a biological drug?
 
Thread starter Similar threads Forum Replies Date
C Biologic Evaluation based on ISO 10993-1 EU Medical Device Regulations 2
O Validation approach for a Photostability Chamber (used for fluid therapy and injectable drug products) Qualification and Validation (including 21 CFR Part 11) 1
S Food Grade or USP Class IV Materials for Manufacturing Injectable Products Other Medical Device Regulations World-Wide 5
somashekar Medical device file Vs Role undertaken by the organization ISO 13485:2016 - Medical Device Quality Management Systems 1
M Medical Device Label - Language EU Medical Device Regulations 2
D MDR: Active medical device or not? Medical Information Technology, Medical Software and Health Informatics 4
H Mapping QMS+business processes in a medical device with class I and IIa+b Process Maps, Process Mapping and Turtle Diagrams 0
Aliken Registration veterinary medical device (laser) requirements Medical Device and FDA Regulations and Standards News 0
K Selling legacy device under MDD to India EU Medical Device Regulations 1
T Classification Accessory Software medical device EU Medical Device Regulations 4
M MOPs of power socket for battery powered device IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
J CGMP Medical device slide deck Manufacturing and Related Processes 1
G MOP for internally powered device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
W AR and Device Classification EU Medical Device Regulations 2
N Auxiliary current limit with coil cell powered device IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
W Which category for new device CE Marking (Conformité Européene) / CB Scheme 2
R Device Master Record Vigilance ISO 13485:2016 - Medical Device Quality Management Systems 5
M Notification Requirements for Medical Device Raw Materials 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Madagascar medical device regulation Other Medical Device Regulations World-Wide 0
R Steam sterilizer medical device reclassification EU Medical Device Regulations 3
G Software Medical Device Classification EU Medical Device Regulations 7
Q Resolution of Measurement Device for a 50' Coil Reliability Analysis - Predictions, Testing and Standards 1
D IEC 60601-1-2: Is EMC immunity testing required for a device without essential performance? IEC 60601 - Medical Electrical Equipment Safety Standards Series 15
R DHF structure for accessories to a parent device US Medical Device Regulations 1
A What's the meaning of the modified device? EU Medical Device Regulations 0
H Harmonized Standard for the refrigerated lab device safety CE Marking (Conformité Européene) / CB Scheme 2
R Legacy Device UDI Requirements EU Medical Device Regulations 5
J Robotic arm with a camera, active medical device? EU Medical Device Regulations 12
A Article 54, Article 61(4) the meaning of marketed device EU Medical Device Regulations 8
D Out of specification procedure for Medical device manufacturing Manufacturing and Related Processes 7
K Medical Device Shipping Container Label Manufacturing and Related Processes 3
S Is Amalgam Separator considered a Medical Device in US and EU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K New to Medical Device QMS and would like advice ISO 13485:2016 - Medical Device Quality Management Systems 9
C Medical device label storage conditions EU Medical Device Regulations 11
W Regulation of medical device in Hong Kong Other Medical Device Regulations World-Wide 1
G User Ejecting Lithium Battery from Device Other Medical Device and Orthopedic Related Topics 4
D Class III license: Add new device to the license system Canada Medical Device Regulations 1
M Inspiring leaders in the medical device industry ISO 13485:2016 - Medical Device Quality Management Systems 5
A Layered Process Audits for Medical Device Manufacturing? ISO 13485:2016 - Medical Device Quality Management Systems 3
I Clinical evaluation for legacy device EU Medical Device Regulations 16
K Non-Device MDDS Clarifications (FDA) US Food and Drug Administration (FDA) 7
T Combined ultrasonic and electrosurgical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
P Transferring medical data from a device (Sec 201(h)): regulatory implications US Medical Device Regulations 3
R Is "SAFE" permitted in class 1 medical device marketing claims? US Medical Device Regulations 1
K Common "modern" network switches suitable for use as a separation device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
C Class 1 non-sterile device, need certified QMS or not? EU Medical Device Regulations 2
T Determining FIPS 140-2 compliance in a medical device Medical Information Technology, Medical Software and Health Informatics 2
I Importing medical device into Canada for exclusive distribution in the U.S. Medical Device and FDA Regulations and Standards News 0
M Camera / microphone with wifi connection on a medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
C Spinal implant predicate device test results 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0

Similar threads

Top Bottom