This message was posted by a user wishing to remain anonymous
Seeking opinions on eligibility of a change for the Changes Being Effected (CBE) route.
I've been trying to convince my RA leadership that our change is eligible, but since our particular division within this large medical device manufacturer does not have prior history with this submission route, my leadership is leaning towards being conservative because they are afraid of "the optics" to our FDA reviewers of using this path. If not CBE, we'd have to submit as a Real-Time Review (and pay $26k and wait longer to implement). I have prior experience with two CBE submissions during my time in another division within this same company. I am a bit taken aback at the hesitancy of this division to utilize a pathway that I believe we are completely eligible for. Here's the details:
Product: PMA product (obviously).
Change: Add a Caution statement to the IFU. Basically this statement is about potential harm in a certain scenario that could arise during use of the product, particularly for a subset of potential device users.
Why: To meet requirements of a standard we claim compliance to (and claimed compliance in the Original PMA). This standard requires disclosure of this potential risk in the IFU.
This product has been on U.S. market for ~5 years. Only recently the company became aware that our contracted tester for this highly-relevant standard for our product misclassified the device component. The misclassification doesn't impact the testing conditions, the results, or the risk ratings (pre and post mitigation) for this particular harm. However, the reclassification into the correct category requires additional disclosures to the patient of the risk in certain situations in order to be compliant to the standard.
Per the FDA website (and also our company's procedures which are based on FDA guidelines) this is what CBEs are [emphasis added where relevant]:
- Special PMA Supplement -- Changes Being Effected - §814.39(d)
- For any change that enhances the safety of the device or the safety in the use of the device.
- For certain labeling and manufacturing changes that enhance the safety of the device or the safety in the use of the device.
- May be placed into effect by the applicant prior to the receipt of a written FDA order approving the PMA supplement.
The following changes are permitted [§814.39(d)(1)]:
- labeling changes that add or strengthen a contraindication, warning, precaution, or information about an adverse reaction;
- labeling changes that add or strengthen an instruction that is intended to enhance the safe use of the device;
- labeling changes that delete misleading, false, or unsupported indications; and
- changes in quality controls or the manufacturing process that add a new specification or test method, or otherwise provide additional assurance of purity, identity, strength, or reliability of the device.
What are you thoughts on the eligibility of this change? Please note - this change is not related to a recall, nor is it driven from a complaint-related process. It was driven from discovery of the component misclassification relative to a standard's category definitions during a file review and resulted in a CAPA.
Thanks.