You are making a design change to a Class II device, so you need to follow all of the requirements of 820.30(i).
In addition, I recommend you look at four other areas that are not explicit in 820.30(i).
Is the change significant in the 510(k) sense? Use the 1997 guidance document, follow the flow charts, and provide complete responses to the questions. The conclusion will tell if a memo to file is sufficient.
Does this change create a new version or model and, therefore require a new DI under the UDI rule? (Even if you have not implemented the label and GUDID portions, you should include the analysis in any design change.)
Is the change an enhancement? This will help you decide reportability under Part 806. Follow the recent guidance document to classify the change.
Does the change affect the ISO 14971:2007 risk management file? You may not have a Risk Management File for the Class I device. You also need to include any interactions with the prior Class II device.
For each of these additional areas, I recommend you formally document your decision and the rationale and include it, as a quality record, associated with the DHF that documents the design change.
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 07-07-2015 09:21
From: Bobbi Siddoway
Subject: Adding a New Instrument
We are adding a new instrument to our knee orthopedic system. The instrument alone is a Class I the system however is a Class II. Is a letter to file sufficient for adding this new instrument?
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Bobbi Siddoway
Salt Lake City UT
United States
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