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FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems

Ajit Basrur

Staff member
Admin
#1
The most recent regulatory agenda says that sometime this month the US Food and Drug Administration (FDA) will issue a proposed rulemaking on the harmonization and modernization of the quality system regulation for medical devices with the specifications of ISO 13485:2016. See https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201904&RIN=0910-AH99

FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation.

AAMI has released a document# TIR102:2019 that provides a mapping of the US FDA 21 CFR requirements to the "regulatory requirements" references in ISO 13485:2016. https://my.aami.org/store/detail.aspx?id=TIR102-PDF

This is an interesting development
 

kj_wilson

Optimistic Global Curmudgeon
#4
If you are the Quality Head at a Medical Device company, you really should be up to speed with the 2016 version of ISO 13485 as well as the current 21 CFR 820 in the USA. This applies to the other related standards and regulations (ISO 14971 Risk Management & FDA "Risk-based approach" come to mind).

I am involved with about 15 global medical device clients and their QMS, and those that are *fully* compliant with the current (2018) FDA-QSR, have no problem becoming ISO 13485:2016 compliant. The reverse is not always true.

This does not mean that cross-compliance is free, nor does it imply that cross-compliance is difficult. It just takes disciplined diligence and attention.

Personal Opinion: The cited proposed rule making is just smoke right now, this sort of proposal usually happens whenever a well-adopted standard (like ISO 13485) is updated. However, US law has other concerns that a standards organization does not. What will probably happen is that a "Guidance" will be issued, explaining how FDA will accept (or not accept) ISO 13485:2016 compliance as evidence of compliance with the QSR.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#5
Personal Opinion: The cited proposed rulemaking is just smoke right now, this sort of proposal usually happens whenever a well-adopted standard (like ISO 13485) is updated. However, US law has other concerns that a standards organization does not. What will probably happen is that a "Guidance" will be issued, explaining how FDA will accept (or not accept) ISO 13485:2016 compliance as evidence of compliance with the QSR.
You may or may not be right - I don't know the internal workings of USA law making.
As a watcher from the outside (for many years) I have a feeling that this time it's different. What you describe above as a possible outcome was already implemented (in a way) in the VARSP initiative several years ago, which evolved to the current MDSAP. The latter is picking up very slowly (apparently), nevertheless it IS picking up, and I guess that as some point it will reach a critical mass, from which point things may move forward quite quickly. And, the basis for MDSAP, which is supported by FDA, is ISO 13485:2016.
 

Watchcat

Quite Involved in Discussions
#6
My take for at least the past year is that people have been saying this for too long and too often, frequently announcing it as a done deal. TO me it sounds like an attempt to exert pressure by rumor, the hope that if everyone keeps saying it, FDA will make it so.

I wouldn't place a wager either way, but if FDA does post a Proposed Rule, I'm considering starting a betting pool to guess the number of comments it gets, perhaps with a trifecta consisting of total number of comments, the number in favor of, and the number against.

The other cool thing about a Proposed Rule is that the comments would finally reveal who it is that has been pushing for this. No idea why AAMI has gotten involved; it's an organization for healthcare technology professionals, not the medical device industry. As far as I know, it offers only professional certifications, not certifications to standards and therefore should have little to no interest or expertise in QMS or ISO 13485, other than selling the standard. I dunno, maybe whoever is pushing for this couldn't get a more appropriate organization to do it.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#7
Partisan utility aside, there is tremendous value in harmonising all major markets under a single system. Why ISO 13485? Because almost everyone is already on board. The USA is the last piece.
 

kj_wilson

Optimistic Global Curmudgeon
#9
Ronen E: I think I understand your perspective, but realize that the FDA's acceptance of Medical Device Single Audit Program (MDSAP) reports only applies for routine FDA inspections of medical device manufacturers, and is technically not a change in law or regulation. In the US, FDA has latitude and discretion on just how it gains evidence of ongoing compliance. The limited acceptance in the US of MDSAP results is valuable for post-approval/clearance devices, but does not fully meet US requirements for pre-approval (pre-clearance) assessments.

Personally, I am all for harmonization and taking global approaches to the development of medical devices and their regulation. The difficulty is that the laws of various countries are the result of political decision-making, and not always strictly on sound scientific (rational/evidence-based) debate.

I do not dismiss the possibility that the proposed rulemaking may eventually lead to changes in US law, I'm just an old pragmatist: lots of proposed rules hit the dockets, usually originating from congress or grass-roots sources, but very few change the law. The coming weeks and months will tell just how seriously FDA, Congress, and Industry take the proposal. I keep my eyes on the FDA's draft guidances. Occasionally, I call on my colleagues in FDA and just ask them what they think.

FDA currently has, based on its wide discretionary authority, the ability to embrace ISO 13485 to an even greater extent, but would (in my experience) internally work against making it the only way to evidence QSR compliance. It is a nuance of US lawmaking that requires any absolute requirement to be codified by the US regulations (this is why the QSR was established and why it looks and feels a lot like the ISO standards).

As far as QMS goes, ISO 13485 and the FDA-QSR are in very close agreement (by design, those of us involved in the establishment of the QSR into US law a few decades ago fully considered global needs).

By the way: AAMI has been involved in medical devices and their regulatory issues for at least the last 20 years (beyond just sterilization and microbiological matters) and have been a vocal proponent of the use of international standards in US regulatory processes.

As for the value of harmonization/unification of regulatory approaches, the benefits will first be seen by manufactures, followed closely by their customer/patients, and then regulatory agencies. This statement is based on experiences from the GHTF (medical devices) and the ICH (pharma). Reading the history of these efforts can be very enlightening.
 

Watchcat

Quite Involved in Discussions
#10
The limited acceptance in the US of MDSAP results
In what way is it limited? By the fact that it is useful only for postmarket devices? Since all devices regulated by FDA are postmarket, that doesn't seem like much of a limitation. As for devices not yet regulated by FDA because they are still premarket, FDA doesn't assess QMS pre-approval except for PMA devices, which are a tiny fraction of all devices that enter the US market.

AAMI has been involved in medical devices and their regulatory issues for at least the last 20 years (beyond just sterilization and microbiological matters) and have been a vocal proponent of the use of international standards in US regulatory processes.
Yes, but why has it done this? This is one answer from an RA colleague:

The cost of the rapidly changing standards AND their TIRS is ridiculous. Even with subscription services. And then there is ISO 13485 pointing to control of External Documents, with expectations you purchase all of these to sit unused as "references". It is a racket. AAMI, ANSI, IEC, ISO, etc.

I have heard similar opinions expressed by many individuals within the industry, including some here in the Cove. My MBA side concurs. The purpose of standards is to benefit various players financially. If they have any other benefits, those are unintended side effects.

Personally, I am all for harmonization and taking global approaches to the development of medical devices and their regulation.
Me too. I would like to see every regulatory agency in the world step up and take full responsibility for establishing its own standards for the protection of its own citizens. Then I would like to see each agency compare its standards with those of other agencies to eliminate pointless inconsistencies.

those of us involved in the establishment of the QSR into US law a few decades ago
So perhaps you can tell me. Were design controls intentionally buried in the QSR (which was presented as an upgrade to the GMP regulation) to assure that ODE would never look at them (or perhaps to give ODE an excuse not to), or was this just a horrible, horrible mistake?
 
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