Submission of foreign data without IRB approval

Z

zmimshen

#1
Is it ok to submit bench data utilizing de-identified imaging without obtaining IRB/ethics approval?
In the country in which the study is conducted there are no such requirements; however, I was wondering if FDA may refuse to accept the data as a result...

According to CFR 46.101 this type of study is exempt since the data cannot be tracked to an individual and no personal data is revieled however 56.101 does not make this distinction...

Anyone has any input?
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
V FDA 510K - Pre Submission Query US Food and Drug Administration (FDA) 6
K Level 1 PPAP Submission APQP and PPAP 11
R Withdraw IMDS submission RoHS, REACH, ELV, IMDS and Restricted Substances 3
G Similarities between format of technical file for CE and ASEAN common submission dossier template (CSDT) CE Marking (Conformité Européene) / CB Scheme 2
L Notified Body submission - Pre-filled syringes EU Medical Device Regulations 2
B Document Retention period for MHRA submission UK Medical Device Regulations 0
M ESTAR 510(k) submission question Medical Device and FDA Regulations and Standards News 0
S Discussion on OBL and OEM test data for submission as per new EUMDR EU Medical Device Regulations 0
V Recommended EU 2017/745 electronic submission format EU Medical Device Regulations 3
L How to find a good 510(k) submission training? Other US Medical Device Regulations 2
L How to find a good online CFDA submission training? China Medical Device Regulations 4
H Do you repeat information throughout your documentation submission? EU Medical Device Regulations 4
S FDA 510(K) submission question US Food and Drug Administration (FDA) 4
B Client lost copy of previous 513(g) submission package and responses US Food and Drug Administration (FDA) 1
J 3P510K submission US Food and Drug Administration (FDA) 2
T Accessories and Parent Device Submission Medical Device and FDA Regulations and Standards News 1
D New license submission - Correct Email Canada Medical Device Regulations 1
B How to submit Pre-submission to FDA? US Food and Drug Administration (FDA) 4
V 510 k submission RTA (Acceptance Checklist ) Other US Medical Device Regulations 8
T IMDS submission without supplier's input? RoHS, REACH, ELV, IMDS and Restricted Substances 5
J Part submission warrant for Level 1 PPAP APQP and PPAP 1
N Traditional 510K Submission-Financial Certification or Disclosure Statement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B Health Canada Submission Canada Medical Device Regulations 2
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 8
S Pre-Submission for Breakthrough Device Designation - What's the threshold? US Food and Drug Administration (FDA) 8
P Writing a presubmission to the FDA prior to the De novo submission US Food and Drug Administration (FDA) 4
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
D Amendment Class II - Please confirm if the submission is by email (Canada) - Help Canada Medical Device Regulations 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
G Gage R&R - Where am I going wrong? Part of a FAIR submission (Aerospace) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
K Submission of MDR File - Partner Companies - Computed Tomography (CT) CE Marking (Conformité Européene) / CB Scheme 10
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
A Some doubts about traditional 510(k) submission US Food and Drug Administration (FDA) 5
A Bench test report translation to English for 510(k) submission Other US Medical Device Regulations 2
S PMS (Premarket Submission) and PMCF Plan EU Medical Device Regulations 5
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 3
J IMDS submission details for aluminium wrought alloys APQP and PPAP 5
K 510(K) File eCopy Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
S Two or more predicates suitable? 510K submission US Food and Drug Administration (FDA) 5
P Predicate Device Information for 510(k) Submission Medical Device and FDA Regulations and Standards News 4
M Timing of 510k submission Other US Medical Device Regulations 9
Ronen E Can anyone please explain this? (510k submission requirement) Other US Medical Device Regulations 14
D First 510(k) Submission - Don't Forget Tips US Food and Drug Administration (FDA) 5
P 21 CFR 807.81 When a premarket notification submission is required Other US Medical Device Regulations 0
J China NMPA medical device submission timelines and clearance rates China Medical Device Regulations 2
D Is Human Factors testing mandatory for a 510(k) submission? Human Factors and Ergonomics in Engineering 16
D Pre-Submission after 510(K) Submission? Other US Medical Device Regulations 4
M CBE (Change Being Effected) 510(k) Submission Other US Medical Device Regulations 2
K 510(K) Submission (Traditional) for Medical Device US Food and Drug Administration (FDA) 17

Similar threads

Top Bottom