SBS - The best value in QMS software

Product Instructions (IFU) - Placement Requirements - ISO 13485:2003/2016

  • Thread starter TempusVernumProcella
  • Start date
T

TempusVernumProcella

#1
HELP - :bonk:

There is a heated discussion underway at work whether or not a product document stating the instructions for use (product insert/IFU) is required to be placed in each primary packaged (non-sterile) IVD box/bag - OR - If they can place an IFU in each Shipping container level instead.
My CEO is asking if it is required through FDA to have the IFU in each pkg level or if we just need to put it in the entire shipping box.

Example: our primary pkg level for some products is 10 units per 1 bag, that 1 pack of 10 is then put into a higher pkg level (50's 100's, etc.) and shipped.

My research says that we don't "NEED" an insert in every 10pk bag, but our procedures state that we do. He is asking if it's 'required' through ISO or FDA to put 1 IFU in each 10pk bag.


Sorry if that was confusing - any insight helps! :thanx:
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
HELP - :bonk:

There is a heated discussion underway at work whether or not a product document stating the instructions for use (product insert/IFU) is required to be placed in each primary packaged (non-sterile) IVD box/bag - OR - If they can place an IFU in each Shipping container level instead.
My CEO is asking if it is required through FDA to have the IFU in each pkg level or if we just need to put it in the entire shipping box.

Example: our primary pkg level for some products is 10 units per 1 bag, that 1 pack of 10 is then put into a higher pkg level (50's 100's, etc.) and shipped.

My research says that we don't "NEED" an insert in every 10pk bag, but our procedures state that we do. He is asking if it's 'required' through ISO or FDA to put 1 IFU in each 10pk bag.


Sorry if that was confusing - any insight helps! :thanx:
For sure you do while your procedure says so. Both FDA and ISO require that your operations be in compliance with your documented and released procedures.
 

somashekar

Staff member
Super Moderator
#3
HELP - :bonk:

There is a heated discussion underway at work whether or not a product document stating the instructions for use (product insert/IFU) is required to be placed in each primary packaged (non-sterile) IVD box/bag - OR - If they can place an IFU in each Shipping container level instead.
My CEO is asking if it is required through FDA to have the IFU in each pkg level or if we just need to put it in the entire shipping box.

Example: our primary pkg level for some products is 10 units per 1 bag, that 1 pack of 10 is then put into a higher pkg level (50's 100's, etc.) and shipped.

My research says that we don't "NEED" an insert in every 10pk bag, but our procedures state that we do. He is asking if it's 'required' through ISO or FDA to put 1 IFU in each 10pk bag.


Sorry if that was confusing - any insight helps! :thanx:
How do you sell to the end user .. say a hospital.
A bag of 10 and multiples of it.. ?
Then one IFU in every bag of 10 meets the purpose. Your IFU and your shipping packaging are not related.
 
Thread starter Similar threads Forum Replies Date
Q Instructions for Use (IFU) - On the Manufacturer's Website vs. On the Product Label US Food and Drug Administration (FDA) 15
B Body Armor Product Labeling Instructions Advice Wanted Manufacturing and Related Processes 4
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
R IATF 16949 Certification for new site with transferred product--what is the impact with CSR and scorecards? IATF 16949 - Automotive Quality Systems Standard 0
William55401 Distributed By Product - Best Practices for Configuration Management and Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 0
R Compatibility studies - combination product CE Marking (Conformité Européene) / CB Scheme 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
dinaroxentool Selling a product in Both UK and EU after Brexit UK Medical Device Regulations 8
P EU MDR Translation of Product Name EU Medical Device Regulations 0
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
V New Product Model CE Mark Certification under MDR EU Medical Device Regulations 0
Sidney Vianna Informational APQP4Wind - Advanced Product Quality Planning for the Wind Power Supply Chain APQP and PPAP 3
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
S How long does it take to register a product with MHRA? UK Medical Device Regulations 3
D Classification of product for clinical trials EU Medical Device Regulations 14
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
B Internal Auditor Competency - Product Auditors Internal Auditing 9
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
S AS9120B - 8.5.2 Delivering Split Product AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Classification of a product according to MDR EU Medical Device Regulations 3
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
L AS9100 - Product and Service Provision 8.5.1q AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
Felony Melony New Product Launch - Safe Launch Customer and Company Specific Requirements 1
Marcel DS How do I know if my product is required be RoHS certified? REACH and RoHS Conversations 6
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
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 7
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
A Software bug fixes after shipping a product EU Medical Device Regulations 3
silentmonkey How to measure severity if my product is designed for emergency use and failure would result in death? ISO 14971 - Medical Device Risk Management 9
D IATF16949 7.5.3.2.1 Record Retention - Our Product or Customer Product? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
H Operational planning and product and service provision when things happen so fast ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T Letter to file for Product Certification CE Marking (Conformité Européene) / CB Scheme 0
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
S California Cleaning Product Right to Know Act - Product Label advice needed Miscellaneous Environmental Standards and EMS Related Discussions 1
S Definition of "worldwide" in view of IATF 16949 and Product conformity IATF 16949 - Automotive Quality Systems Standard 3
H PCD remains valid for new product ISO 13485:2016 - Medical Device Quality Management Systems 11

Similar threads

Top Bottom