Design changes a week after regulatory submission

#1
Hi everyone,

We recently filed a 510(k) submission. A few days after we submitted the dossier, the engineers made a few design changes without informing Regulatory. There was no documentation of the changes and there was no impact assessment on approval. My question is, while the product is still under review by FDA, can we make amendments to the regulatory submission if these changes were found to be notifiable to the regulatory authority? The 510(K) modification guidance assumes that a product has already been approved, but in our case when the product is pending review, how do we disclose the changes? I understand there are changes that do not require notification, but if the changes are found to significantly affect safety and effectiveness of a product that has just been submitted, what should we do? I look forward to your responses.


Thank you.
 
Elsmar Forum Sponsor

sagai

Quite Involved in Discussions
#2
I do not know the answer for your question, I have found usefull however before the CDRH assistance of FDA.
Small Business Assistance

They were very helpful for the question I had at that time.

Hope this somehow helps.
Cheers
 
Thread starter Similar threads Forum Replies Date
J Ethicon suture box design changes - 2019 Other Medical Device Regulations World-Wide 2
C Partial Design Validation and changes to a critical supplier 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Design Verification - Managing Changes Design and Development of Products and Processes 4
T Design Changes - Updating the Design and Development File EU Medical Device Regulations 5
O PFMEA - Reducing Severity (S) Ranking - Manufacturing Process Design Changes FMEA and Control Plans 4
Q Looking for documents relating to Medical Device Design Changes Document Control Systems, Procedures, Forms and Templates 5
A Reporting of Design Changes (Color Change Only) EU Medical Device Regulations 5
Uriel Alejandro Small changes on Design Outputs AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 11
A When to verify and when to validate Design Changes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Dealing with Device/Design changes by a "Letter to File" vs. 60601 Retesting IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
M Clause 7.3.7 Design and Development Changes - Requirements Scope? IATF 16949 - Automotive Quality Systems Standard 6
K 7.3.7 Control of Design & Development Changes AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
M Doubt about Customer Changes to Product Design Features AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
T How to link Process Design Changes in Serial Production to Design & Development? Design and Development of Products and Processes 6
A Design/Change Control Procedure - How to cope with Changes during Development? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 26
K Procedure for Categorising Substantial Changes to Design CE Marking (Conformité Européene) / CB Scheme 4
V Procedure to notify Health Canada, FDA and Japan Pal for Minor Design Changes Canada Medical Device Regulations 5
Le Chiffre 510(k) Changes: More bench testing and stricter design controls? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D ISO 9001 - Customer Approval of Design Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q ISO 9001:2008 - 7.3.7 - Review of Evaluation of Design and Development Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G Job Traveler Guidance - Frequent changes in the part design Document Control Systems, Procedures, Forms and Templates 6
A DoD Classification of Class 1 and 2 Design Changes and what spec it's called out in Design and Development of Products and Processes 2
A What is the proper definition for Class 1 & 2 design changes AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
L Testing of Small appliances design changes Reliability Analysis - Predictions, Testing and Standards 1
C How to make risk analysis for design changes to existing devices ISO 14971 - Medical Device Risk Management 17
J Can We Exclude ISO9000:2000 Clause 7.3.7 (Control Of Design And Development Changes)? Design and Development of Products and Processes 7
C QS-9000 Clause 7.3.7 - Design Changes - How is this interpreted? Design and Development of Products and Processes 7
W 7.3.7 Control of Design & Dev. Changes Design and Development of Products and Processes 5
Stuart Andrews Design Record Changes and PPAP Re-submission? Design and Development of Products and Processes 13
W Custom production shop with design changes Design and Development of Products and Processes 2
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Reliability Analysis - Predictions, Testing and Standards 0
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
DuncanGibbons How is the arrangement between Design and Production organisation envisaged? EASA and JAA Aviation Standards and Requirements 4
L Design & Development of a SERVICE Service Industry Specific Topics 13
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A AS9102B - 3.6 Design Characteristics and form 3 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
P Design FMEA - Detection Rating criteria ISO 14971 - Medical Device Risk Management 3
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
J Iterative design and production for custom made products ISO 13485:2016 - Medical Device Quality Management Systems 3
T Design Input detail & specificity ISO 13485:2016 - Medical Device Quality Management Systems 4
J Design file for pre-existing products - Inputs and Outputs ISO 13485:2016 - Medical Device Quality Management Systems 5
D Design Transfer Template capturing Customer Specific Requirements Other Medical Device Related Standards 3
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
M Looking for a Presentation on Design for Excellence (DfX) Manufacturing and Related Processes 2
Similar threads


















































Top Bottom