Episode description
This is the audio from RQM+ Live! #54, recorded 5 May, 2022. Listen as our panelists provide insight on the changes in the new requirements and what steps companies should take to update their quality system.
FDA requires companies to conform to the current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR 820). However, many other international regulatory authorities require compliance to the internationally recognized regulatory requirements of ISO 13485.
This misalignment has created extra challenges for companies who market devices in multiple countries, as they have to meet two different sets of requirements. After many years of effort, including participation in the Medical Device Single Audit Program (MDSAP), FDA has released a proposed rule to amend the CGMP requirements of the QS Regulation to align more closely with ISO 13485:2016. While 21 CFR 820 and ISO 13485:2016 share many requirements, there are various differences regarding risk management principles, quality system record requirements (i.e. Device Master Record, Design History File, Device History Record), labeling and packaging controls and others. While this creates the opportunity to have one quality system to address all country requirements, companies need to update their quality system to ensure it complies with the new requirements.
In this show, subject matter experts including former FDA CDRH representatives provide insight on the changes in the new requirements and what steps companies should be taking to update their quality system.
Panelists:
- Ralph Asencio, MBA, BSME – Vice President of Technical Services
- Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services
- Richard Freeman, Ph.D. – Director, Global Audit Practice
- Kevin Go – Project Engineer, RAC (former FDA CDRH Lead Reviewer)
Questions:
2:28 -- Is the FDA actually proposing to adopt ISO 13485 or just proposing to be close to it?
4:52 -- Why are they just not adopting it?
6:23 -- What is an overview of the changes to part 820?
8:18 -- In terms of timelines, where is the FDA on its journey of adopting ISO 13485?
10:00 -- Will the FDA keep in lockstep with SIO 13485 updates?
11:10 -- As new technologies come into play, how receptive are they into adopting SaMD lifecycle, requirements and guidance, etc.?
14:18 -- When the two standards are sort of in one, what are the significant changes that manufacturers will observe?
18:10 -- Commentary on MDSAP...
20:21 -- What kind of impact will the change and adoption have on the FDA?
24:30 -- Does all of this allow you to streamline what you have? Can this be a reset button?
26:47 -- What should manufacturers be doing now as we prepare for this transition?
29:17 -- If you're part 820 compliant and have 13485 as certification, are you already compliant with this new initiative?
32:29 -- What would RQM+ do if we were engaged?
33:37 -- Is this just another step in harmonization?