Non-Sterile Class 2 Medical Device Shelf Life

J

Jim H

#1
We produce a class 2 medical device that we have been under ICH guidelines for our stability and shelf life determinations. Our product contains an aerosol with no drug or active ingredient. We have looked into sterile medical device stability guidelines (ANSI/ISO 11607) to extend our expiry date from 2 to 3 years. We have the real time data to do that. My question is, is there another protocol like 11607 that addresses non-sterile medical devices?
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
I assume from the terminology of your post that you're asking about US FDA regulation.

Any such standard or guidance would be specific to the clinical function of your device.
 
M

MIREGMGR

#4
you may want to have a look a this FDA guidance doc:

Shelf life of Medical Devices
Agreed, though that 1991 content is pretty basic stuff. Presumably the International Conference on Harmonization reference was to newer-than-23-year-old guidance.

FDA does have a few device-type-specific guidances that might apply to the subject device, depending of course on what it is.
 
Thread starter Similar threads Forum Replies Date
Z Class 2 medical device - Process Validation - Test sterile or non-sterile units? Qualification and Validation (including 21 CFR Part 11) 4
A Medical Device Class 2A, non sterile bodyworn packaging requirements CE Marking (Conformité Européene) / CB Scheme 7
N Registering a Class 1 Sterile Medical Device - Currently selling a Non-Sterile 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
R Shipping Stability for Class III IVD (Non Sterile) Medical Device Other Medical Device Related Standards 7
J Biocompatibility for Class I Non-Sterile Medical Device EU Medical Device Regulations 2
R How to go about package validation on a class II, non-sterile device US Food and Drug Administration (FDA) 4
Q Expiry Dates on a Non-Sterile Class 1 Medical Device (5 Year Shelf Life). Other Medical Device and Orthopedic Related Topics 11
A Need to register with CA for Class I (Non-Sterile and Non-Measuring) Medical Device EU Medical Device Regulations 4
M Packaging Requirements for Non-Sterile Class II Medical Devices EU Medical Device Regulations 11
M Class I non-sterile, non-measuring: Requirements fulfiled? EU Medical Device Regulations 4
J Requirements for Own Branding Class I Non-Sterile Device? ISO 13485:2016 - Medical Device Quality Management Systems 1
K Requirements for Exporting from US to EU - Class I MD non-sterile, non-measuring EU Medical Device Regulations 7
A Non-sterile liquid bandage as Class 1 - Anyone concur or disagree? EU Medical Device Regulations 17
A Documentation required for launch of a non-sterile exempt class 1 medical device ISO 13485:2016 - Medical Device Quality Management Systems 7
B Bioburden monitoring for surgical instrument provided non-sterile EU Medical Device Regulations 3
Y Packaging validation for non-sterile Medical Equipment Other Medical Device Related Standards 1
A Single use non-sterile syringe used in the oral cavity - Laboratory test advice US Food and Drug Administration (FDA) 7
D Standard guide for shelf life determination of non sterile component with degradation materials Reliability Analysis - Predictions, Testing and Standards 1
M MDR 2017/745 sterile and non-sterile labeling EU Medical Device Regulations 12
T No Defined Shelf Life/Expiration Date - Disposable single-use, non-invasive, non-sterile Other Medical Device Regulations World-Wide 2
S Package performance testing for non-sterile Hydrogels US Food and Drug Administration (FDA) 1
E Cleaning Validation Process of Non-Sterile Implants and Instruments Other Medical Device Related Standards 2
R Use of the "Non-Sterile" Icon - ISO7000-2609 EU Medical Device Regulations 4
N Medical device non sterile packaging requirement CE Marking (Conformité Européene) / CB Scheme 1
F Bioburden Testing requirements for Non-Sterile Dental Products EU Medical Device Regulations 6
V Cleanliness/Bioburden for Non-Sterile Gas Path Medical Devices Other Medical Device Regulations World-Wide 7
Y Shelf Life of Non-Sterile Disposable Drug Inhaler 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
shimonv Packaging Validation for Non-Sterile Package EU Medical Device Regulations 5
I Use of the Non-Sterile Symbol (EN980/ISO7000/ISO15223-1) Other Medical Device Related Standards 3
J 510k file requirements for non-sterile medical device accessories 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
O Bioburden Testing - Non Sterile Product / Tapes - ISO 11737-1 Other ISO and International Standards and European Regulations 9
S Is Pyrogen testing done on non sterile units? Other Medical Device and Orthopedic Related Topics 13
A Cleaning instructions for our non sterile, single use products EU Medical Device Regulations 6
D Packaging Addition - Non-sterile barrier to protect the whole package 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
M Contract Manufacturer of a Non-Invasive, Non-Sterile Device and FDA Registration US Food and Drug Administration (FDA) 2
B Labeling of a Non-Sterile Component that connects to a Sterile System via a Cable 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P ETO Sterilisation of Single Use Part supplied in Non-Sterile State EU Medical Device Regulations 12
C Cleanliness Specifications that apply to non-sterile medical devices ISO 13485:2016 - Medical Device Quality Management Systems 12
C CE Marking for Sterile and Non-sterile device - Surgical blades EU Medical Device Regulations 2
C ISO 11737 - Bioburden testing for non-sterile products Other ISO and International Standards and European Regulations 10
J Medical Devices: Initial Design - Sterile or Non-sterile Design and Development of Products and Processes 10
I Non-sterile device - Rapid Test Kits - ISO 14644 Clean Room required? ISO 13485:2016 - Medical Device Quality Management Systems 12
B Non-sterile - Does anyone know of a universal symbol? ISO 13485:2016 - Medical Device Quality Management Systems 5
E Qualification for non gmp service providers Supplier Quality Assurance and other Supplier Issues 1
R MDD x PPE Directive - Statement of Non-Applicability EU Medical Device Regulations 3
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
C Non-EU Language Requirements Other Medical Device Regulations World-Wide 3
A Non-Conformances Found After 3rd Party Sorting Supplier Quality Assurance and other Supplier Issues 12
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 4

Similar threads

Top Bottom