Does FDA allow comparing with the competitors Medical Device

Elsmar Forum Sponsor

invitro_spain

Involved In Discussions
#3
Yes, of course. If you are thinking to submit a 510k and you have selected a competitor's device as your predicate; you have to use it during your performance testing and method comparison studies.
 
Thread starter Similar threads Forum Replies Date
R Does FDA allow e-labeling? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Does FDA allow you to withdraw a CAR once it is in your system Nonconformance and Corrective Action 3
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
R When does the FDA consider a component a medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
William55401 How Often Does FDA State Consultant Recommended in a Pharma WL? US Food and Drug Administration (FDA) 1
M Does cFDA accepts FDA approval or CE marking? China Medical Device Regulations 1
P Warning Letter 1999 - Where does the FDA make older warning letters available? US Food and Drug Administration (FDA) 4
supadrai How does the FDA count violations of, for example, misbranding? (Medical Devices) Other US Medical Device Regulations 1
K Where does the FDA post its various compliance dates? US Food and Drug Administration (FDA) 2
R FDA 510K - Does the FDA accept the testing report from other countries? Other US Medical Device Regulations 1
I 510k Performance Testing Studies (Raw Data) - What does the FDA expect 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q When does the FDA deem something "where appropriate"? 21CFR820.30(g) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
M FDA 21 CFR 820.250 - Does "valid statistical" always mean math? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
B How does a Kit Assembler proceed after FDA Establishment Registration? Other US Medical Device Regulations 3
S Does FDA expect suppliers to be independently assessed to 21 CFR Part 820 ? US Food and Drug Administration (FDA) 4
Y FDA - Does anyone have conduct the validation on GR&R worksheet before? Qualification and Validation (including 21 CFR Part 11) 7
K What liability does the QA Manager/Management Rep hold? (US FDA environment) Career and Occupation Discussions 4
AnaMariaVR2 St. Jude Medical does the unthinkable: Warns of FDA warning letter before FDA issues US Food and Drug Administration (FDA) 5
R Does FDA require monitoring competitor device failures for preventive action? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Does any one have FDA 21 CFR Part 820 QSR training material? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
B Does a US FDA Class I (exempt) device require a Statement of Intended Use? Other US Medical Device Regulations 3
D Will buyers (hospitals) require IEC 60601, even when FDA does not? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C Does FDA cGMP apply to Laboratory Equipment? ISO 13485:2016 - Medical Device Quality Management Systems 2
C Medical Device Malfunction during misuse - Does this need to be reported to the FDA? Other US Medical Device Regulations 5
D DHF Review - When does the FDA review the DHF? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Does Canada have an equivalent to FDA preIDE meeting? Canada Medical Device Regulations 4
A How long does it take US FDA to issue a Warning Letter Close Out Letter Other US Medical Device Regulations 2
R First MDR (Medical Device Report) - Does the FDA give feedback? US Food and Drug Administration (FDA) 4
Y Does FDA have regulations about Braille use for Medical Device Other US Medical Device Regulations 2
T Does FDA consider Flow Charts sufficient instruction for SOPs? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
E Does the US FDA issue GMP certificates? Other US Medical Device Regulations 2
M Does a dental handpiece need FDA permission? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
Q FDA Inspector - What does it take to become an FDA inspector? US Food and Drug Administration (FDA) 4
E Does European Manufacturer with ISO 13485 need QSR820 for FDA registration? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C Does FDA change the information about" wire transfer" US Food and Drug Administration (FDA) 1
S Does anyone know if ISO publishes audit findings/results much like the FDA ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
I 510k Approval - Does the FDA look for Clinical Data 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S How often does the FDA inspect organisations outside of the USA? US Food and Drug Administration (FDA) 12
T Submission of 510(k) - Does the FDA require a predefined structure of the content? ISO 13485:2016 - Medical Device Quality Management Systems 2
S FDA Validation - Does one have to conduct validation for Computer Servers? Qualification and Validation (including 21 CFR Part 11) 8
gdwaikle Does The FDA oppose the use of Process Flow Charts? ISO 13485:2016 - Medical Device Quality Management Systems 8
P How does the FDA's SMG 2020 compare to ISO/TR 10013:2001? US Food and Drug Administration (FDA) 2
R Does anyone have any information on FDA's SMG 2020 issued Oct 04. US Food and Drug Administration (FDA) 1
L CE Mark - FDA - Class I traction systems - What is involved and how long does it take EU Medical Device Regulations 5
Q FDA Establishment Registration - Does registration require compliance to the QSR? ISO 13485:2016 - Medical Device Quality Management Systems 8

Similar threads

Top Bottom