How to determine "generic/me too" device?

I

itscloud

Starting to get Involved
#1
#1
Hi

What are the document requirements for submitting a "generic/me too" registration? Where can you find information of predicate devices?
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0
L How to determine / validate Medical Device Storage Conditions ISO 13485:2016 - Medical Device Quality Management Systems 1
John C. Abnet ISO 9001 4.4.1 "...shall determine the processes needed..." ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 72
S Is using ANSI/ASQ Z1.4-2008 the correct sampling plan to determine Pass/Fail of Apparel measurements? AQL - Acceptable Quality Level 4
E How do you determine if hipot is necessary for a cable product? Manufacturing and Related Processes 8
J Standard used to determine if check fixture gauge is acceptable Reliability Analysis - Predictions, Testing and Standards 2
M Measurement Error - How to determine what is acceptable? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
S How to determine & document Organizational Knowledge of a company Document Control Systems, Procedures, Forms and Templates 4
O Monitoring performance - How do I determine performance measurement basis within my organization? Misc. Quality Assurance and Business Systems Related Topics 4
T IEC 60601-1 - Risk assessment to determine the liquid - 11.6.3 IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
Ashok sunder How to determine the internal and external issues in ISO 45001 standard? Occupational Health & Safety Management Standards 2
C ICP versus AA: How to determine appropriate specification for assay method verification Qualification and Validation (including 21 CFR Part 11) 1
samer Do we have to determine Educational level for all Staff as pr 7.2 b clause? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Calibration of Pressure Gauge, How to Determine Calibration Tolerance General Measurement Device and Calibration Topics 1
S Supplier Qualification - How do we determine which suppliers to qualify? ISO 13485:2016 - Medical Device Quality Management Systems 9
K ISO 13485:2016 Cl. 4.2.3 - Determine QMS Processes, Monitoring, Measuring, etc. ISO 13485:2016 - Medical Device Quality Management Systems 4
A Compliance Obligations - Implementing 6.1.1 and 6.1.3 NOTE - Determine risks and... ISO 14001:2015 Specific Discussions 1
B Auditing Senior Management to determine the Effectiveness of Management Processes IATF 16949 - Automotive Quality Systems Standard 6
R What testing would you run to determine if a device is "Clean"? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B Maximum Material Condition with Bonus - Determine Cpk for this one kpc Measurement Uncertainty (MU) 2
Q Tissue Adherence Test to determine how Tissue sticks to Gauze Other US Medical Device Regulations 2
C DOE - How to determine optimal settings and transposing data Statistical Analysis Tools, Techniques and SPC 2
insect warfare Cannot determine what type of medical device this product is.... 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Buckyb Are KPIs a requirement to determine Process Effectiveness? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
M Is a Real Time Stability Study required to determine Expiration Date? EU Medical Device Regulations 9
K How to determine rated input power for the markings? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
I How to determine the thread wire size needed - Buttress Thread Gauge General Measurement Device and Calibration Topics 3
M How to determine Process Capability using Minitab 17 Capability, Accuracy and Stability - Processes, Machines, etc. 6
V How does ASQ determine Exam Cutoff Marks Professional Certifications and Degrees 2
R How to Determine Working Voltage & Tolerance for Isolation Barriers? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
apestate How to determine all regulatory and statutory requirements to be met? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Gage R&R Study (Crossed) - How to determine Process Tolerance Using Minitab Software 4
D How can I determine a process metrics? Manufacturing and Related Processes 1
D Can I use the % Tolerance to determine the actual process tolerance? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
R How to determine the Thickness tolerance of the Cold Rolled Steel Manufacturing and Related Processes 6
T Technical regulations that determine the acceptable limits of cigarettes General Measurement Device and Calibration Topics 4
J How does Layout Inspection determine Reference Value? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
Q PPAP - How to determine the "Design Record Change Level" APQP and PPAP 2
K 7.6 c) c) Have Identification in order to determine Calibration Status Calibration Frequency (Interval) 3
S How to determine part that is most difficult to sterilize Other Medical Device Related Standards 10
G How to determine if a Standard is Auditable General Auditing Discussions 15
L Who and when to determine AQL for our product inspection AQL - Acceptable Quality Level 1
R 4 Factors 3 Level DOE to determine which factors are significant Using Minitab Software 2
C How to determine a sample size for comparison purposes ? Quality Tools, Improvement and Analysis 2
S How to determine Preventive Maintenance and Calibration Grace Periods General Measurement Device and Calibration Topics 4
J How to determine a Capability Study for Low-Volume Suppliers Capability, Accuracy and Stability - Processes, Machines, etc. 3
C Statistics equation to determine the number of samples in a lot Statistical Analysis Tools, Techniques and SPC 8
S How to determine the Air Clearance for Floated Secondary Circuit IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
somashekar How to Determine the Necessary Employee Competence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
F ISO 22000 Clause 7.4.4 to determine whether a control is a CCP or and OPRP Food Safety - ISO 22000, HACCP (21 CFR 120) 2

Similar threads

Top Bottom