Device Shelf Life Extension to 48 months without involving the FDA

I

image182

Involved In Discussions
Hi all,

I have small questing related to the shelf life of a device.

Reviewing current and draft guidance documents, its fairly clear that we can change the expiration date of the device by documenting the evidence internally.

Current Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (1997)
B9: Change in packaging or expiration dating --> Yes --> Documentation

Draft Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (2019)
B4: Is there a change in packaging or expiration dating? --> Yes --> B4.1: Is the same method or protocol, described in previous 510(k), used to support change --> Yes --> Documentation

Therefore, for example, if we gain 510(k) clearance for a device with a 12 month shelf life, if we had appropriate data we could expand the shelf life by e.g. 6 months by documenting this internally and not involving the FDA.

I'm wondering to what extremes this could be taken? Would it be possible to gain clearance for a device with a 1 month shelf life. Then expand the shelf life to 48 months without involving the FDA?

The reason i'm asking is that if we're gaining clearance on a device using accelerated aging data, the 510(k) review time and the shelf life study could be run in parallel and result in us getting the device to market a lot sooner. e.g.
  • gain a data for a short shelf life
  • Submit the 510(k)
  • Wait e.g. 200 days for the completion of the shelf life study and the clearance of the device
  • Document the change for the shelf life internally for the planned long shelf life
  • Launch the device

Thanks for your help!
 
J

JeantheBigone

Quite Involved in Discussions
My gut feeling is "no."

First of all, change in shelf life / expiration date is a modification which according to FDA may require a new 510(k).

https://www.fda.gov/MedicalDevices/...sions/PremarketNotification510k/ucm134575.htm

With that, the answer to this question is firmly in the grey area.

However, FDA thinking is that there are reasonable shelf lives for different devices.

https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM466475.pdf

So a 510(k) for a device that typically has a shelf life of five years but only claims a shelf life of one month would probably raise the reviewers' eyebrows. :rolleyes: I doubt it would get cleared without a discussion about the unusually short shelf life. FDA is not known for wanting manufacturers to take things to extremes. :)

Once the device is cleared, FDA leaves it to the manufacturer to decide whether a new 510(k) is needed or not. If you can justify and document that safety and effectiveness are not affected, then you can extend the shelf life. The risk you take is that FDA may disagree.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Z Shelf life automatically set to 6 months when no device performance shelf life data provide Medical Device and FDA Regulations and Standards News 5
T Class III device and shelf life data requirements US Medical Device Regulations 7
C Medical Device Shelf life studies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
shrutisancheti Predicate device accelerated aging - 1 year of shelf life is already over Other Medical Device Related Standards 1
H Frequency of shelf life/sterilization/bench studies conducted on a medical device Other Medical Device Related Standards 1
D Ethylene Oxide Sterile Implantable Medical Device Shelf Life Extension Other Medical Device Related Standards 1
N Sample Size Justification for Medical Device Shelf-Life Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
J EU Medical Device Class I - Stability (Shelf Life) Test EU Medical Device Regulations 2
J Non-Sterile Class 2 Medical Device Shelf Life Other Medical Device Related Standards 5
A Medical Device Shelf Life vs. Warranty Period Canada Medical Device Regulations 6
N Does Class I (exempt) device have requirements of Shelf Life and Expiration Dating ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
U Shelf Life Requirement for Class II Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 26
S How to validate Device Shelf Life? CE Marking (Conformité Européene) / CB Scheme 8
Q Expiry Dates on a Non-Sterile Class 1 Medical Device (5 Year Shelf Life). Other Medical Device and Orthopedic Related Topics 11
E Reference Standard for Shelf Life Testing of Packaging for Sterilized Medical Device Other US Medical Device Regulations 3
M Shelf Life Testing of a Sterile Medical Device Other Medical Device and Orthopedic Related Topics 40
A Medical Device (Gloves) Stability (Aging) testing and Shelf Life Other Medical Device and Orthopedic Related Topics 15
L Shelf-Life vs. Lifetime of Medical Laser Device Other Medical Device and Orthopedic Related Topics 4
A Shelf Life for Products in Storage - Medical Device company ISO 13485:2016 - Medical Device Quality Management Systems 5
J Moisture sensitive device - New reel of a BGA with expired shelf life Other ISO and International Standards and European Regulations 5
J Shelf life control - Examples: solder paste, moisture sensitive device, epoxy Nonconformance and Corrective Action 3
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 10
M OTS (Off-the-shelf) Medical Device Accessories - Camera EU Medical Device Regulations 1
S Off the Shelf Parts - Serial to USB adapter for a Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P EN 62304 Safety Class of an ECG device designed to be used in clinical situations when patient is in immediate danger. IEC 62304 - Medical Device Software Life Cycle Processes 3
M If there is any restriction on the transportation of Used Medical Device (with blood) from Canada to other countries? Canada Medical Device Regulations 4
M If there is any restriction on the transportation of Used Medical Device (with blood) from EU to other countries? EU Medical Device Regulations 2
M How to transport the device with blood abroad according to the US regulation? US Medical Device Regulations 2
K Leakage current tests for battery powered device with IEC 62368 compliant charger IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
adztesla Sterile packaging validation for medical device - ASTMD4332 and ISTA2A ISO 13485:2016 - Medical Device Quality Management Systems 3
W Change predicate device CE Marking (Conformité Européene) / CB Scheme 1
P On-going stability study requirement for medical device US Food and Drug Administration (FDA) 2
N Regulations for Medical Device in Jamaica Other US Medical Device Regulations 0
M Classification of device according to China medical device regulations China Medical Device Regulations 4
J What Device Should I use for Gage Study? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
M Q: In what circumstances can a clinical investigator submit an EFS/IDE for the Significant Risk Device? US Medical Device Regulations 1
adztesla Design change and Process change Class 3 medical device Medical Device and FDA Regulations and Standards News 2
Ed Panek Use of Investigational Device i n Phase 1 Clinical Trial in EU EU Medical Device Regulations 1
M Importing a custom component for our medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C CMO for class 2, 510k exempt device Manufacturing and Related Processes 4
adztesla Adding new supplier/ Medical device design change ISO 13485:2016 - Medical Device Quality Management Systems 2
adztesla Medical device Drawing related change justification Other Medical Device Related Standards 0
O Medical Device With 2 Power Cords IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Stoic Which medical device companies are using Recombinant Factor C (rFC) instead of Limulus Amebocyte Lysate (LAL) for endotoxin testing? Sustainability, Green Initiatives and Ecology 0
A Class Ir device have to be certified under MDR ? EU Medical Device Regulations 2
I Commercializing a non medical device software Medical Information Technology, Medical Software and Health Informatics 10
I Non-medical device software Preventive Action and Continuous Improvement 1
C California Prop 65 for medical device labels US Medical Device Regulations 3
adztesla GDP rules- redline drawings in medical device Medical Device and FDA Regulations and Standards News 2
A Lot number on label vs lot number on device - Traceability ISO 13485:2016 - Medical Device Quality Management Systems 0

Similar threads

Top Bottom