The new Final Rule for the FDA is coming and at Advena we thought it might be handy to give you a quick guide to the changes. This is designed to be high level advice, and of course we would recommend you conduct a gap assessment of your QMS before implementation. The good news is that if your QMS is already ISO13485:2016 compliant then the regulation is designed to align the FDA specific requirements much better with your existing QMS.
Here are some considerations if you are already ISO13485:2016 & FDA compliant:
820.10: DMR, DHR, DMF are no longer necessarily valid definitions MDF (Medical Device File) is now used as the generic term as per ISO13485:2016.
820.10: Do your UDI procedures currently reflect the requirements for UDI under the FDA?
820.10: Are your advisory notice procedures FDA compliant (Part 806.)
820.20-30: Have you Ensured all FDA complaint requirements including reporting are captured in the complaints process. Inclusive of record requirements?
820.20-30: Have you considered the process for disclosure of confidential information to the FDA?
820.40-45: Do you ensure labelling and packaging has been examined for accuracy prior to release or storage where applicable and do you retain labels with the Device History Record? Do these contain all required elements?
820.40-45: Are labelling and packaging operations defined in such a way that they would prevent mixups?
Another thing to consider is that the FDA assessors will now be allowed to review a wider variety of documents in the QMS. The QMSR gives the FDA the authority to inspect management review, quality audits, and supplier audit reports. The exceptions that existed in the QS regulation at § 820.180(c) are not maintained in the QMSR
Businesses already certified or aligned with ISO 13485:2016 will encounter minimal adjustments due to the introduction of the QMSR. It’s important to revise procedures and work instructions to eliminate outdated QSR requirements and references to outdated terminology. For those without pre-existing experience with ISO 13485:2016 the job is considerably more challenging but still manageable with the right preparation.
Contact Us
For further information and personalised guidance, please feel free to reach out to Advena via either our website contact page, www.advenamedical.com, email (info@advenamedical.com) or phone (01926 800153) to start a conversation today.
