FDA Guidance on Interim Use of ISO13485 for Medical Device Manufacturer

D

daamor

#1
Hello-

I am currently working on transitioning a mfg facility to become QSR compliant. I've done a lot of QMS work in the past and remember the differences between 13485 and the QSR and am trying to leverage the fact that our site was audited by BSI (and passed) to use as an interim strategy while our remediation is under way.

Essentially:
We passed a 13485 audit. We have gaps to the QSR. We have a resolution of those gaps on a quality plan. In the meantime, I'd like to have some FDA official guidance or indication that passing a 13485 audit or something similar is at least good thing. I'd like to use that as rationale for not having to shut down production and claim that it is low risk (compliance and safety wise).

I'm aware this probably doesnt exist but every so often, a weird clause here or there may find itself into a regulation or guidance document that we QEs can jump on ;)

Thanks!
 
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D

Dudes

#2
Would the "Voluntary Audit Report Submission Pilot Program" help for your justification? (http :// www. fda. gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm212795.htm - DEAD 404 LINK UNLINKED)

Basically, the program would allow you to submit your ISO 13485 audit report to postpone an FDA audit

FDA Guidance said:
Specifically, a device manufacturer whose establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members1 using International Organization for Standardization (ISO) 13485:2003 Technical Corrigendum 1:2009, “Medical devices – Quality management systems – Requirements for regulatory purposes,” (or a national adoption of this standard, e.g., EN ISO 13485:2003/AC:2009, CAN/CAS ISO 13485 13485:2003) may voluntarily submit the resulting audit report to FDA. If, based on that report, FDA’s analysis or compliance decision meets the requirements of the FDA’s Medical Device Compliance Program 7382.845 for “Situation II,” that there is minimal probability -- in light of the relationship between the quality system deficiencies observed and the particular device and manufacturing processes involved -- that the establishment will produce nonconforming and/or defective finished devices,2 then FDA intends to use the audit results as part of its risk assessment to determine whether that establishment can be removed from FDA’s routine inspection work plan3 for one year from the last day of the ISO 13485:2003 audit. The effect of removal from the routine inspection work plan is that FDA intends to postpone the establishment’s bi-annual inspection for that one-year period. The voluntarily submitted ISO 13485:2003 audit report provides FDA some information on the conformance of the manufacturer with basic and fundamental quality management system requirements for medical devices.
 
Last edited by a moderator:
M

MIREGMGR

#3
VARSP requires three years of audit reports without majors; can only be applied for within 90 days of the last day of the most recent ISO13485 audit; and in any case does not exempt the facility from compliance with 21CFR820 etc. It only exempts from QSIT 1/2 inspections.

I don't know of any clause, weird or otherwise, to help.
 
R

rclanzillotto

#4
No such clause. One approach is mock audit given by someone with knowledge of both QSR and ISO 13485 requirements
 
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