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
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
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
S Mexico medical device registration - for demo Other Medical Device Regulations World-Wide 1
Ed Panek GDocP For Med Device US Medical Device Regulations 3
B Clinical evaluation according to equivalence with another device EU Medical Device Regulations 4
E Insulation class II device with metal enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S EU Medical Device Regulations EU Medical Device Regulations 6
K Sample size calculation for the medical device with multiple indications. e.g. suture US Food and Drug Administration (FDA) 3
Doninina Trend Reporting for medical device class IIb according to MDR EU Medical Device Regulations 4
C Medical Device Gamma Irradiation Validation per VDmax25 (ISO 11137) Qualification and Validation (including 21 CFR Part 11) 1
S Medical device other market Medical Device and FDA Regulations and Standards News 1
T § 820.120 Device labeling - "shall be documented in the DHR" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Stoic Warning letter examples for medical device companies related to the pharma guidance on data integrity? US Medical Device Regulations 1
A 510(k) and DeNovo on same medical device for different indications? US Medical Device Regulations 4
I ISO13485 Folder Structuring for Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5
K Device part of combination product certification requirements Medical Device and FDA Regulations and Standards News 3
S Change in material vendor - Medical device ISO 13485:2016 - Medical Device Quality Management Systems 4
I Medical Device Accessory Responsibility Other Medical Device Related Standards 7
A NMPA registered device VS country of origin (free sales certificate) China Medical Device Regulations 4
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
E Device compatibility with other company's devices US Food and Drug Administration (FDA) 0
D New Device Post Market Requirement for MDR EU Medical Device Regulations 3
A Biocompatibility: Selection of worst-case device Medical Device and FDA Regulations and Standards News 2
J Medical Device Manufacturing Manufacturing and Related Processes 3
B Post-Market Surveillance Requirements for Canada - class IIa/IIb device Canada Medical Device Regulations 1
N Direct Part Marking of the "CE" symbol- Class I Device EU Medical Device Regulations 1
M An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER) EU Medical Device Regulations 0
J Question regarding classification of custom made device EU Medical Device Regulations 5
B How FDA define a new variant/generation or a new device US Medical Device Regulations 11
O Regarding design and development requirements for a medical device EU Medical Device Regulations 6
U Leakage test Standard for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Tablet integrated into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
S New indication for a third party device US Medical Device Regulations 2
F Philippines: Old Certificate of exemption for Class B device and new LTO. How to proceed? Other Medical Device Regulations World-Wide 0
Ed Panek Is this a medical device? US Medical Device Regulations 2
D Are there Controlled Documents in a DMR (Device Master Record)? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Medical device testing lab/service standard Other Medical Device Related Standards 1
K Medical Device file and "Component" Manufacturers? Other Medical Device and Orthopedic Related Topics 6
R CE MARKED DEVICE REGISTER SEPARATELY (LOCALLY) IN EU COUNTRIES? CE Marking (Conformité Européene) / CB Scheme 2
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
C Legacy device under Class A sterile devices EU Medical Device Regulations 0
C Statistics/sampling plan for medical device Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
T IVD Device Software - Risk Classification IEC 62304 - Medical Device Software Life Cycle Processes 16
J Can you assign two EMDN codes to a single device for EUDAMED? EU Medical Device Regulations 3
A Non-medical device testing in the medical system IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
H Is testing according to IEC 60601-1 & IEC 60601-1-2 mandatory for a device being registered under MDR? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S Training in D&D for engineers with no medical device experience Design and Development of Products and Processes 8
P Classification of Active non-implantable diagnostic device EU Medical Device Regulations 7
M Software as Medical Device import activities for Chile and Mexico Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom