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

Ronen E

Ronen E

Problem Solver
Moderator
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.
Click to expand...
 
M

Mark Meer

Trusted Information Resource
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...
 
C

Candi1024

Quite Involved in Discussions
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?
 
M

Mark Meer

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

Candi1024 said:
I've also heard that under MDSAP rules, the FDA must be shown a full report of all audit findings if asked.
Click to expand...

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:
D

DannyK

Trusted Information Resource
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

Ronen E

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

Mark Meer said:
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."
Click to expand...

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?
 
M

Mark Meer

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

Ronen E said:
What's wrong with that?
Click to expand...

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...
 
C

Chrisx

Involved In Discussions
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.
 
M

Mark Meer

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

Chrisx said:
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.
Click to expand...

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

Ronen E

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

Mark Meer said:
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...
Click to expand...

Very well, so we think along similar lines. :agree:
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Medical Device News FDA News - 07-09-18 - FDA Encourages Use of Enteral Device Connectors Other US Medical Device Regulations 0
Ed Panek Looking for help... FDA Pre Sub, IVD, Investigational level experience US Medical Device Regulations 0
U How should we build the FDA inspection preparedness team for FDA inspections at factories? General Auditing Discussions 0
D FDA combo product-need to define direct & indirect impact regarding safety,quality & regulatory.Can anyone point me in right direction-SupplierMgmt 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B What is meant by "post production" if the device is yet to receive FDA approval? ISO 14971 - Medical Device Risk Management 5
B FDA Requirements for medical device to be used for training purposes only US Food and Drug Administration (FDA) 9
M Class III IVD PMA Amendment to FDA Medical Device and FDA Regulations and Standards News 1
L Verification of wireless QoS and coexistence during FDA certification of medical devices Medical Device and FDA Regulations and Standards News 1
W Notify FDA of Change of Ownership? US Food and Drug Administration (FDA) 2
G FDA requirements for risk analysis US Food and Drug Administration (FDA) 2
V Anyone have templates for FDA GMP Guidelines for supplement manufacturers? US Food and Drug Administration (FDA) 0
N FDA mechanical bench testing Manufacturing and Related Processes 5
V Regulatory consultants for US FDA ANDA - pharma / drug products Consultants and Consulting 0
M Clinical evaluation process of FDA and MDR Medical Device and FDA Regulations and Standards News 2
S Is it possible to obtain FDA clearance (510k) without meeting QSR? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
P Biocompatibility testing ISO-10993 for FDA submission Other Medical Device Related Standards 7
Ed Panek FDA Submission Question US Medical Device Regulations 3
Y The day after the FDA US Food and Drug Administration (FDA) 2
U FDA foreign inspection and COVID19 US Medical Device Regulations 4
Y Convenience pack FDA US Food and Drug Administration (FDA) 3
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
N FDA medical devices US Food and Drug Administration (FDA) 1
R US FDA 510k Australia TGA US Food and Drug Administration (FDA) 0
B How FDA define a new variant/generation or a new device US Medical Device Regulations 11
G FDA Annual Registration and Listing US Food and Drug Administration (FDA) 7
T Book Excerpt: Drugs and the FDA: Safety, Efficacy, and the Public’s Trust Book, Video, Blog and Web Site Reviews and Recommendations 0
E The FDA regulations (21 CFR 312.3): Is it allowable that IND sponsor involves more than one individual or organization? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
P Looking for Korean FDA Drug Master File requirements for packaging systems. Other Medical Device and Orthopedic Related Topics 1
M IEC 62366 Hazard-related Use Scenario vs FDA Critical Task EU Medical Device Regulations 3
N Free sale and FDA US Food and Drug Administration (FDA) 1
N FDA class 1 US Food and Drug Administration (FDA) 6
G UDI in EU vs FDA EU Medical Device Regulations 1
S Initial Audit FDA US Medical Device Regulations 3
T FDA PMA review process - advisory panel timing? Other Medical Device and Orthopedic Related Topics 0
E FDA & Internal Audits US Medical Device Regulations 3
N Importing into US without 510K/FDA Clearance US Medical Device Regulations 1
N FDA class 2 Device QS Requirements US Food and Drug Administration (FDA) 2
T FDA labeling requirements US Food and Drug Administration (FDA) 2
S FDA Contract Manufacturer and Applicant US Food and Drug Administration (FDA) 0
R IVD Software FDA/CLIA doubts Medical Device and FDA Regulations and Standards News 1
R IVD software FDA and CLIA US Food and Drug Administration (FDA) 2
T FDA level of concern vs IEC 62304 safety classification - 510(k) exempt device Other US Medical Device Regulations 13
K Change in address on ERLM US FDA: Implications to import US Medical Device Regulations 0
V FDA 510K - Pre Submission Query US Food and Drug Administration (FDA) 6
M Document Control ISO and FDA ISO 13485:2016 - Medical Device Quality Management Systems 7
C FDA 510k documentation requirements US Food and Drug Administration (FDA) 1
T Link GMDN code and FDA product code US Medical Device Regulations 5
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
M How does FDA determine OAI and VAI after inspection? ISO 13485:2016 - Medical Device Quality Management Systems 0
K Non-Device MDDS Clarifications (FDA) US Food and Drug Administration (FDA) 7

Similar threads

Top Bottom