Number of lots required for stability testing of a Class II device in the 510(k)

lilybef

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#1
I have question about the number of lots required for stability testing of a Class II device in the 510(k). We have a request from the reviewer of our last submission for 3 lots used in testing shelf life. I cannot find anything to support his request other than the Drug guideline. Has anyone ever had a question about in relation to the number of lots needed for stability report in a 510(k)?
 
#2
Lilybef,

as you correctly pointed out, lot-based shelf life testing is a typical concept of pharmaceutical products. Is your product a combination device or a degradable device? Has the reviewer given you any indication why potential lot-based variances should be tested?

HTH,
Gerhard
 
#3
Until now, I have not heard of FDA/ODE reviewers are suggesting that shelf life (stability) testing should be performed on multiple lots. I have seen some FDA guidance documents that suggest testing multiple lots for characteristics such as coating particulates, corrosion and a few other characteristics, but not in the context of shelf life testing.

Some "seemingly dated" FDA medical device guidance documents mention testing multiple lots for shelf life testing. For example:

FDA 1991 Guidance: Shelf Life of Medical Devices (attached)
- This is the only FDA device shelf life guidance that broadly covers all types of devices
- It refers to 1985 and 1989 FDA guidance documents for contact lenses that mention testing 3 lots, and 2 to 3 lots, respectively

More recent FDA device guidance documents I checked that discuss shelf life testing but do not mention how many lots to test:
- 2019 PTCA Catheters Guidance
- 2010 Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems Guidance
- 2018 Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling DRAFT Guidance
- 2018 Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions DRAFT Guidance

The FDA-recognized pharma guideline for testing 3 lots/batches is mentioned in ICH Q1A
STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Data from formal stability studies should be provided on at least three primary batches of the drug substance.

Other documents I checked that do not mention testing multiple lots/batches:
- ASTM F2914 2012 SG for Identification of Shelf-life Test Attributes for Endovascular Devices (interesting since it provides examples of attributes typically not impacted by aging (e.g.. stent/hard plastic dimensions, MR compatibility, marker radiopacity, corrosion resistance)
- EN ISO 11607-1 2017 Packaging for terminally sterilized medical devices-Part 1-Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1 2006+A1 2014)

Note: "Stability" is a term that is mostly used in the pharma industry, whereas "shelf life" is the term I have seen primarily used for medical devices. However, 11607-1 does use the term "stability" and does not use "shelf life".
 

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lilybef

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#4
Hi Sam and Plan B,

My medical device is not a combination product nor is made of degradable materials. My team is baffled on the requirement for 3 lots for stability/shelf life.
Thanks for the inputs!
 

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