FDA encourages industry to participate in Medical Device Single Audit Program (MDSAP)

Ronen E

Problem Solver
Staff member
Moderator
#1
From an FDA newsletter:

The Food and Drug Administration (FDA) joins the Medical Device Single Audit Program’s Regulatory Authority Council in encouraging medical device manufacturers to participate in the Medical Device Single Audit Program (MDSAP) Pilot. The Medical Device Single Audit Program is expected to begin transition to full implementation on January 1, 2017.

What is Medical Device Single Audit Program (MDSAP)?
As envisioned by the International Medical Device Regulators Forum (IMDRF), the FDA developed MDSAP in collaboration with regulatory authorities from Australia, Brazil, Canada, and Japan. IMDRF recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.

MDSAP enables medical device manufacturers to contract with an MDSAP-authorized Auditing Organization (AO) to conduct a single audit against the relevant medical device regulatory requirements of all fully participating regulatory authorities. For more information about the Medical Device Single Audit Program, please visit the FDA MDSAP Pilot Webpage.

In an effort to help inform the medical device manufacturing community about MDSAP, the FDA posted ten new medical device education modules to the CDRH Learn Program website.

What is CDRH Learn?
CDRH Learn is a multimedia catalog of online educational modules intended to provide information about medical device laws, regulations, and policies that is comprehensive, interactive, and easily accessible. The format for each topic is chosen to present the information in the most effective way possible.
 
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Mark Meer

Trusted Information Resource
#2
Re: FDA encourages industry to participate in Medical Device Single Audit Program (MD

One way they could encourage participation is to lower the number of required audit hours.

As I've expressed in other threads, we got quotes from a few agencies, and all worked out to be approximately 3 times as expensive as maintaining our present ISO 13485 certification.

In principle, it seems like a good idea. But the added cost is a huge disincentive for companies to voluntarily enroll in the program...
 

Candi1024

Quite Involved in Discussions
#3
Re: FDA encourages industry to participate in Medical Device Single Audit Program (MD

I've also heard that under MDSAP rules, the FDA must be shown a full report of all audit findings if asked. Currently we are not required to show ISO13485 findings, only the certificate.

Does anyone know if this is true?
 

Mark Meer

Trusted Information Resource
#4
Re: FDA encourages industry to participate in Medical Device Single Audit Program (MD

I've also heard that under MDSAP rules, the FDA must be shown a full report of all audit findings if asked.
I also seem to recall talk of audit results being shared through an "MDSAP Portal" database, which will be shared amongst participating agencies (FDA, TGA, Health Canada,....).

This document seems to indicate that participating agencies will have access to the reports through such a database...

Also this article from LNE G-Med:
"After the MDSAP assessment the results (audit report) will be uploaded into a database that will be accessible by participating regulatory authorities."
 
Last edited:

DannyK

Trusted Information Resource
#5
Re: FDA encourages industry to participate in Medical Device Single Audit Program (MD

Small companies will see their audit costs rise.
I was at a conference with the FDA MDSAP representative and he said that the minimum time for a surveillance audit is 4 days.
There are many small or virtual manufacturers that will get out of CMDCAS because of the added costs. They usually have a 1 or 1.5 day surveillance audit.

Registrars will have to find extra resources to accommodate additional time and also to replace auditors who are doing consulting as well.

I am a CMDCAS lead assessor and will not be allowed to perform MDSAP audits since I am also a consultant.

I have no problem accepting this rule but I find it hard to believe that most of the companies will transfer from CMDCAS to MDSAP before January 1, 2019, which is the Health Canada deadline.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: FDA encourages industry to participate in Medical Device Single Audit Program (MD

I also seem to recall talk of audit results being shared through an "MDSAP Portal" database, which will be shared amongst participating agencies (FDA, TGA, Health Canada,....).

This document seems to indicate that participating agencies will have access to the reports through such a database...

Also this article from LNE G-Med:
"After the MDSAP assessment the results (audit report) will be uploaded into a database that will be accessible by participating regulatory authorities."
What's wrong with that? I thought that the whole idea was that you'd be audited once and that would serve for multiple regulatory domains / authorities. To me it seems natural that an authority granting clearance would have access to the information that allows such clearance.

Would it be better to be actually audited by each one of these authorities, instead?

The only manufacturers to gain from lack of transparency are the ones that have something to hide. Isn't it so?
 

Mark Meer

Trusted Information Resource
#7
Re: FDA encourages industry to participate in Medical Device Single Audit Program (MD

What's wrong with that?
Where did you get the impression I was insinuating there was anything wrong with this?

As I've expressed, my biggest gripe is simply the huge added financial burden...
 

Chrisx

Involved In Discussions
#8
Re: FDA encourages industry to participate in Medical Device Single Audit Program (MD

If you previously participated in the voluntary ISO 13485 submission process, you had to submit your audit report to FDA. In this regards, MDSAP is no different. FDA never accepted just submitting an ISO 13485 certificate.

I actually agree with FDA that audit duration according to IAF is not long enough, especially considering additional time is needed to cover the regulatory requirements of the CFRs. It will all depend upon whether companies feel the extra cost is worth avoiding an FDA inspection. For sure, we would have been inspected by FDA long ago, if we hadn't participated in the voluntary ISO 13485 submission process. The district office even cancelled one inspection after we informed them that we were a participant and had been taken off the routine inspection schedule for 1-year.

Unfortunately without the threat of FDA inspection, compliance has become less of a priority for my employer. Perhaps the additional time of an MDSAP inspection will force some changes.
 

Mark Meer

Trusted Information Resource
#9
Re: FDA encourages industry to participate in Medical Device Single Audit Program (MD

I actually agree with FDA that audit duration according to IAF is not long enough, especially considering additional time is needed to cover the regulatory requirements of the CFRs.
I can't help but feel the FDA's audit duration calculation could be use some work.

The procedure assigns specific times for audit task, but does not seem to consider things such as:

  • How efficiently is the system organized? Should the task time be the same for a paper-based system (where it can take minutes to dig up a particular referenced record) versus an electronic system (where records can be retrieved immediately)?
  • How complicated is each process? Should the task time be the same for a company with a complicated device, with a tonne of suppliers and intricate manufacturing process, versus a simple device whose manufacturing process is straight-forward?
  • How many records are there? Should the task time be the same for a company that has received 2 complaints in the past year versus one that has received 200?

To assign task-based times, in my opinion, is to penalize those companies that run efficient/simple/small systems, because the auditors will end up either scrutinizing more, or finish faster yet bill for the same number of hours.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Re: FDA encourages industry to participate in Medical Device Single Audit Program (MD

Where did you get the impression I was insinuating there was anything wrong with this?

As I've expressed, my biggest gripe is simply the huge added financial burden...
Very well, so we think along similar lines. :agree:
 
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