Hmm. Pre-validation sterilization runs/data are needed for the OQ and PQ portions of the sterilization process validation. Otherwise, such data/results from a sterilization process that hasn't yet been validated are (in my experience) of limited utility (if any at all) pursuant to the basic principles and theory of sterilization process validation. Moreover, unless there is device-specific guidance, special controls and/or a requirement in a device-specific classification regulation, FDA's general policy is that sterilization process validation need not be completed or reviewed before granting 510(k) clearance. For example, FDA's screening acceptance process maintains that the sterilization validation report is not required. And this generally holds true when the sterilization process validation gets completed after 510(k) clearance. There are some exceptions to this, such as in an Abbreviated 510(k) where the clearance is based on the Sponsor's declarations of conformity (which require that such conformity
has been achieved rather than
will be achieved). And sometimes FDA reviewers inappropriately ask for things that aren't really needed for the substantial equivalence decision; maybe this is one of those cases. And sometimes, the FDA winds change.
We would need to know the exact device type, 510(k) type, and to see all of the exact correspondence that took place between the Sponsor and FDA regarding the sterilization topic in order to be able to give a more definitive read on this case.
------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------
Original Message:
Sent: 16-Aug-2021 19:51
From: Anonymous Member
Subject: Sterilization Validation
This message was posted by a user wishing to remain anonymous
Thanks for your reply.
The sterilization method is not a novel method.
I stated in the 510k application that sterilization validation would be completed and provided the sterilization parameters, per FDA guidelines. (In my past this was accepted by FDA, however in more recent submissions, a batch or full validation was required for 510k clearance.)
In response to the 510k, the reviewer replied that they require the sterilization validation prior to 510k clearance. I offered the batch/lot sterilization, which was accepted. Now that the full sterilization validation is complete, I'm wondering if I need to provide FDA the full sterilization validation or if internal documentation would be acceptable.
Original Message:
Sent: 16-Aug-2021 18:50
From: Kevin Randall
Subject: Sterilization Validation
FDA's basic policy is that 510(k) review and clearance of the subject device's sterilization process validation results is not generally required unless there is something novel about the sterilization method. Accordingly, if an existing 510(k) clearance was achieved without submission of sterilization validation results, then that would generally indicate that the sterilization method is well established (not novel) and thus eligible for subsequent implementation of the sterilization process based on internal documentation of the validation results rather than 510(k) submission of those results.
I am curious about the statement of having "obtained clearance by providing a sterilization data for a batch lot" before having completed the sterilization process validation. Perhaps that statement is meant to refer to the proposed sterilization cycle parameters (i.e., proposed cycle temperature, duration, dose, etc.). Indeed, actual sterilization data from a sterilized batch/lot would ultimately be of little value for FDA before the sterilization process is validated. Moreover, FDA's general policy doesn't include requiring batch sterilization results/data as a condition for 510(k) clearance. Without further background, I would say that, even if a Sponsor included batch sterilization data in a 510(k), it was likely considered by FDA to be something the Sponsor voluntarily included but not used by FDA as a basis for its clearance decision.
------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 14-Aug-2021 19:32
From: Anonymous Member
Subject: Sterilization Validation
This message was posted by a user wishing to remain anonymous
Hi,
I filed a 510k for an implant and obtained clearance by providing a sterilization data for a batch lot. After clearance we completed sterilization validation based on acceptable results from 3 batch lots. Could you provide feedback on whether this sterilization validation data needs a 510k clearance or whether internal documentation is acceptable. Thanks!