QSR - Design Control on Existing Device not Designed following QSR

M

mat_lerner

#1
Hi all,

We are a small (<20 employees) Canadian manufacturer of a specific scientific instrument. Our field of market is expanding gradually into clinical testing and we are looking to follow the trend. This means our instrument will have to become a medical device for us to enter that field. This means comply with ISO 13485 and FDA regulation.

Our primary market is the US so we asked the FDA via a 513(g) request to classify our device, it comes out to be a Class 1 and subjected to QSR. Our instrument is controlled by software so under 820.30 a) 2 i) it means we have to implement design controls.

The instrument was R&Ded years ago without any kind of design control. Even worse, we have next to no documentation on the design phase. No formal meetings were held, so no design planning / input - output definition were written anywhere. The design verification (testing of performance) was conducted quickly without any written trail / report. Forget about any risk management. Forget about a DHF... The software was also coded without any plans or requirements specifications.

As I see it, the requirements were conveyed verbally between a small team and we have next to no written records of the design phase.

We do have sparse electronic / mechanical plans, datasheets scrambled around in multiple folders without any structure.

The rest of the QSR is pretty well covered: over the years we implemented procedures, work instructions, tests to support the quality system we have in place. However to this date no design control procedure is established, even less followed.

After reading quite a bit about inspection I see that FDA inspectors ask to see proof that design controls were followed while designing the device. Which we can't produce...

My question: how could we comply to 820.30 (Design control) if none were followed in design? Is it impossible? If so it means to develop a new device from the design phase with the complete QSR implemented from the beginning?

Thanks
 
Elsmar Forum Sponsor
H

HPLC_Help

#2
Hi, Mat -

I am going through exactly the same thing! Here is a thread I started a couple weeks ago on the topic.

The way we have proceeded (and we are a bit different from you in that our device is an assay for blood donor screening) is to review all of our protocols related to running the assay, and building the components, and to ask ourselves "Why did we do this? What requirement were we trying to fulfill?" In doing so, we have compiled a bunch of requirements, and then we are explaining how our activities/designs fulfilled those requirements.

The end result will be a Design History File that we can refer to whenever we make upgrades so as to stay compliant with Design Control reg's.

We intend to inform FDA that we did not have design controls in place at the time of development, as the assay was developed years before we ever thought of screening blood, and that the Design Controls were put in place retrospectively.

This process was okayed by our Quality consultant who informed us that in the past couple years the bulk of his business has been in putting together Design Controls for products that were developed without them. It is the process he has used.

I'd love to hear more feedback, and get your take. I haven't heard much about this problem, so it's good to hear others are facing it as well.

H_H
 

yodon

Staff member
Super Moderator
#3
I think what H_H suggests is reasonable. You're essentially saying that at this point in time, we're now a medical device and this is our design. This is also similar to what I've seen with prototypes that have been 'in development' for years but then someone decides that it's time to commercialize. The "history" doesn't exist but the efforts are made to define and document the design.

I would just add that you should also do a risk assessment. Risk controls are considered requirements (design inputs).
 
Thread starter Similar threads Forum Replies Date
G Understanding Identification of Design in QSR 21 CRF Part 820.30 Design Control (f) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A QSR (820.30 part e) Design Review and Design Control Responsibilities 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
G Legacy Product - Do we need follow QSR 820? Design Verification and Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
W What is "Design Input" by QSR, 21 CFR Part 820 ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C Definition Design Transfer - New requirement of QSR 820 - What is Design Transfer? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
W FDA QSR Inconsistency? Design Validation Design and Development of Products and Processes 17
H Sample Design Plan that complies with FDA QSR, ISO 13485 & 14971. ISO 14971 - Medical Device Risk Management 5
C Medical Device: QSR and Clinical Trials and Design Controls ISO 13485:2016 - Medical Device Quality Management Systems 3
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
Marc Problem with 21 CFR Part 820 - US FDA Quality System Regulations (QSR) sub-forum link - 2 May 2019 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
D FDA QSR task checklist based on inspection citations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B Classes/ Online Training on ISO 13485:2016 and FDA QSR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 5
S Supplier Evaluation - Is a supplier score card a requirement under ISO and QSR? ISO 13485:2016 - Medical Device Quality Management Systems 7
V QMS / QSR - Reference to Framework - Templates - Procedures for Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
Y ISO 13485:2003 &FDA QSR (21 CFR 820) Quality Manual,34 Procedures and Form Book, Video, Blog and Web Site Reviews and Recommendations 8
A How to obtain Preamble to Quality System Regulation (QSR) ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
P FDA QSR Inspection Consultant Recommendations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
shimonv Classification of Complaints from Beta Sites - Complaints Definition per QSR 820.3 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
H USFDA -QSR Audit Check List 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
I Recording of In Process Data to Meet FDA QSR 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Can I approve my own Documentation per FDA QSR 21 CFR Part 820? ISO 13485:2016 - Medical Device Quality Management Systems 1
A How many processes for an FDA Quality System (QSR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
P What's the difference between ISO13485 and FDA/QSR? ISO 13485:2016 - Medical Device Quality Management Systems 16
D Off-the-shelf SW S.O.P. for non-product QSR regulated and non-regulated applications IT (Information Technology) Service Management 6
S OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicability 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
A Does any one have FDA 21 CFR Part 820 QSR training material? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
Q How Demings Point 9 (of his 14 points) is related to the FDA QSR Quality Tools, Improvement and Analysis 3
M ISO 13485 and FDA QSR Employee Training Requirements when Procedures are Revised Manufacturing and Related Processes 5
B FDA QSR Data Analysis & Trending Requirements US Food and Drug Administration (FDA) 5
W Injection Molding Validation Required or Not - FDA QSR 820.75 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
A Purchasing Information Requirements - ISO 13485 Clause 7.4.2 and FDA QSR Supplier Quality Assurance and other Supplier Issues 2
W Auditing to multiple standards & requirements - CMDR, MDD, ISO13485, QSR. General Auditing Discussions 3
Q ISO 13485, FDA's QSR, CMDR, MDD: Seeking Internal Audit Correlation Matrix Various Other Specifications, Standards, and related Requirements 3
S FDA 21 CFR 820 QSR Quality Manual example wanted 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M FDA QSR Requirements - Checklist for Class II Medical Device Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D How to Measure QSR Training Effectiveness? Training - Internal, External, Online and Distance Learning 6
M Practical Reasons Behind The ISO 13485/QSR Regulations ISO 13485:2016 - Medical Device Quality Management Systems 6
C QSR 820.120 labeling and packaging control 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C Questions about the "change control procedure" in FDA's QSR manual 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M CLIA vs. QSR Audit Differences - and - Audit templates for CLIA audits ISO 13485:2016 - Medical Device Quality Management Systems 3
D Definition Q - Definitions of all the Q's - QM, QMS, QP, QSR, etc. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 18
T What would the FDA expect to see when they ask for our QSR? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 20
D Administrative personnel training - ISO 13485 and FDA QSR requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
GStough FDA QSR (Quality System Regulation) Training Needed in the Southeastern USA Training - Internal, External, Online and Distance Learning 7
D Presentation on Subject: Potatoes (QSR interested in the potato market) Misc. Quality Assurance and Business Systems Related Topics 17
A Re-manufactured vs. Refurbished under FDA QSR ISO 13485:2016 - Medical Device Quality Management Systems 2
K QSR Sections for a Medical Device - Seven questions ISO 13485:2016 - Medical Device Quality Management Systems 9
C Software recommendations for CAPA that will meet the FDA QSR & Part 11 Quality Assurance and Compliance Software Tools and Solutions 4
M Online QSR Training with Testing? Training - Internal, External, Online and Distance Learning 2
S QSR (Quality System Regulation) Overview Training powerpoint .ppt presentation ISO 13485:2016 - Medical Device Quality Management Systems 9

Similar threads

Top Bottom