How to interpret the definition of clinical and preclinical trials?

N

normhowe

#1
Hello,

We are trying to define the differences between pre-clinical and clinical research. We have a simple class 2 device. Let's just say for the purpose of discussion that it is worn on the wrist. If, during the design of a modification of the device, we were to try the device on our own wrist, just to see if it fits. Would that be considered a clinical trial? thus requiring an IDE and approval from an IRB?
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Re: How to interprete definition of clinical and preclinical trials?

A Quick Bump!

Can someone help with this question? Thank you very much!
 

Pads38

Trusted Information Resource
#3
Re: How to interprete definition of clinical and preclinical trials?

Exempt Studies
In accordance with 21 CFR 812.2(b), sponsors and investigators of certain studies are exempt from the requirements of 21 CFR Part 812, with the exception of §812.119 (disqualification of a clinical investigator). Examples of exempt studies are consumer preference testing, testing of a device modification, or testing of two or more devices in commercial distribution if the testing does not collect safety or effectiveness data, or put subjects at risk
From here:
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf
 

Attachments

Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
V How to interpret AQL sampling tables AQL - Acceptable Quality Level 5
Q How do you interpret this dimension in my drawing Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
Q IATF 16949 Cl. 4.4.1.2 - Product Safety - How to interpret IATF 16949 - Automotive Quality Systems Standard 13
B How to interpret Grindometer Gage R&R Results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
L How to interpret the average R bar Value shown in the R Chart Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
K How to interpret Clause 7.6 for a service company? Service Industry Specific Topics 11
G Guidance Document to interpret IEC 60601-1 EU Medical Device Regulations 2
P How to interpret statement like 'Maintain a Procedure' Miscellaneous Environmental Standards and EMS Related Discussions 1
S How to interpret a Linear Regression in Minitab? Using Minitab Software 3
Q How to read and interpret an SIPOC (Suppliers Inputs Process Outputs Customers) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Transport Vehicle Thermal Regulation - How would you interpret this requirement? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A How to interpret Minitab Results? What is difference in Cpk and Ppk values? Using Minitab Software 2
C How to interpret Measurement Uncertainty (MU) Measurement Uncertainty (MU) 3
T Please help me interpret my GR&R results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
T Gage Bias and Linearity - How to interpret the Minitab results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
F Gage R&R - How to interpret results? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
W MDR Reporting - How to interpret requirements for MDR Other US Medical Device Regulations 14
T SPC Data - Autocorrelation - How do I interpret this result? Statistical Analysis Tools, Techniques and SPC 17
S Could someone tell me what are the results of a Gage R&R & how to interpret it? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
D How to interpret TS Clause 7.5.1.4 Preventive and Predictive Maintenance? IATF 16949 - Automotive Quality Systems Standard 8
J How do you audit or interpret 'Where Appropriate' in ISO 9001 Clauses such as 7.4.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P How to Interpret Caliper GR&R (Gage R&R) Graphical Result Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
D How do we interpret the following XmR Trend Chart data? Statistical Analysis Tools, Techniques and SPC 3
D How to interpret np chart data - Monitoring 6 medical records Statistical Analysis Tools, Techniques and SPC 6
Q Looking for Case Studies for How to interpret the requirements of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
0 How to interpret s and x bar control charts Statistical Analysis Tools, Techniques and SPC 5
C CUSUM Chart - Can some one throw some light on use and how to interpret? Statistical Analysis Tools, Techniques and SPC 8
Peter Fraser "Anither language" - I'll Interpret your 'Jargon' Misc. Quality Assurance and Business Systems Related Topics 1
K Gage R&R - How do I interpret the %PV & %TV results? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
N How should I interpret Voice of the Customer QS-9000 - American Automotive Manufacturers Standard 1
S "Level of Control" over Suppliers - How do you Interpret and Accomplish Supplier Quality Assurance and other Supplier Issues 1
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
S Definition of "worldwide" in view of IATF 16949 and Product conformity IATF 16949 - Automotive Quality Systems Standard 3
S Importer definition EU Medical Device Regulations 0
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
M Definition of Done - New Product Phase to the sustaining phase Manufacturing and Related Processes 3
M Help me improve the definition for internal PPM Manufacturing and Related Processes 3
D Tolerance definition based on expected Cp/cpk Reliability Analysis - Predictions, Testing and Standards 14
D BS EN 62304 - Medical-Relevant Data C.5 - Definition of IEC 62304 - Medical Device Software Life Cycle Processes 5
P Definition of production tooling in IATF16949 clause 8.5.1.6 IATF 16949 - Automotive Quality Systems Standard 4
J Sample size definition in an Automotive SMT pilot lot run Misc. Quality Assurance and Business Systems Related Topics 1
J Here is my definition of Defect Mapping Quality Tools, Improvement and Analysis 2
D Definition of "Critical Laboratory Equipment"? General Measurement Device and Calibration Topics 1
Z Definitive definition of design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R Definition Key Supplier - Definition of Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
A Definition of customer in ITP (Inspection & Test Plan) Contract Review Process 3
F MEDDEV 2.7/1 rev 4 and MDR - Definition of Description of Principles of operation EU Medical Device Regulations 4
S Definition of "servicing activities" - Spinal Implants ISO 13485:2016 - Medical Device Quality Management Systems 4
T Custom made medical device MDD vs MDR definition CE Marking (Conformité Européene) / CB Scheme 12

Similar threads

Top Bottom