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
Staff member
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
Staff member
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
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
C Combination Products - Distributor of the device? EU Medical Device Regulations 0
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
N Drawing tolerance vs. Measurement device General Measurement Device and Calibration Topics 4
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
D Medical Device Accessories Other Medical Device Regulations World-Wide 1
C GUDID Device record history Medical Device and FDA Regulations and Standards News 2
K Doubt on insulation class of a device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
dgrainger Informational UK guidance on Device regulation from Jan 2021 published EU Medical Device Regulations 10
dgrainger Informational UK guidance on Device regulation from Jan 2021 published Other Medical Device Regulations World-Wide 4
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
M EU MDR - Labilities when a device is discontinued from the Market EU Medical Device Regulations 1
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
S Work performed in Canada on US patients using US device Canada Medical Device Regulations 1
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
Beliz Biocompatibility Testing for Laser Epilation Device EU Medical Device Regulations 2
A Packaging device with accessories already on the market Other Medical Device Regulations World-Wide 0
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0
J UCLA extension Medical Device Engineering Program Training - Internal, External, Online and Distance Learning 0
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 2
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
A How to make sure whether the predicated device is marked with EC certificate? EU Medical Device Regulations 8
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
O ANATEL certification of Medical Device Other Medical Device Regulations World-Wide 0
B MDR equvalent device - can you use a medicine as an equivalent 'device' EU Medical Device Regulations 8
Ajit Basrur FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems (7-2020) US Food and Drug Administration (FDA) 0
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 1
A Legal Manufacturer Medical device US Food and Drug Administration (FDA) 2
D Device functionality over service life - Objective evidence required? Design and Development of Products and Processes 10
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
K Sterile barrier system symbols - Label redlines for a Class III device (Kit Box) EU Medical Device Regulations 0
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 1
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW EU Medical Device Regulations 7
T Loaded spring device - Active medical device? EU Medical Device Regulations 1
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1

Similar threads

Top Bottom