Has anyone here assessed the latest Abbreviated 510(K) guidance document?

M

MDRexpert

Involved In Discussions
#1
#1
A relatively new FDA abbreviated 510(K) guidance is published and I was wondering if anyone has assessed the gap analysis or created a summary report to state if the updated guidance is applicable to their QMS. Can you please share some ideas or scrubbed version? Thanks!
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
M

MDRexpert

Involved In Discussions
#2
#2
Can someone help me how this change will effect in "510K" procedures. I am updating our SOP's based on this update.
As well as "notification of changes to Regulatory agencies (EU/US) procedures.
 
Last edited:
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D Has anyone here had any experience with PQ-FMEA software? FMEA and Control Plans 1
Marc Has anyone here gotten Gigabyte Fiberoptics (Internet) to home? Coffee Break and Water Cooler Discussions 3
C Has anyone here set up a Quality Clinic? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
A Service commitment - Has anyone here already worked with this approach? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Has anyone has been through an MDR audit? (3/2020) EU Medical Device Regulations 1
M Has anyone heard of Run at Risk? Manufacturing and Related Processes 15
B ASA Aviation Supply Association - Has anyone heard of ASA? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
D Has anyone had sudden challenges from Korea-MFDS? Other Medical Device Regulations World-Wide 1
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
L Has anyone heard of the 2 pan system? Manufacturing and Related Processes 6
M Does anyone has a good verification and validation plan template? ISO 13485:2016 - Medical Device Quality Management Systems 3
D Has anyone undergone a BARDA (HHS) audit as part of their grant process? Other Medical Device Regulations World-Wide 0
Sidney Vianna LinkedIn bug - Anyone has any idea of how to fix this? Posts not showing for me in a Group feed. Coffee Break and Water Cooler Discussions 2
K Has anyone used QAI for training? Training - Internal, External, Online and Distance Learning 7
S Has anyone completed IATF 16949 Certification - Share your Audit Experience? IATF 16949 - Automotive Quality Systems Standard 2
S Has anyone created a Turtle Diagram reflecting the new ISO 9001:2015 Structure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Has anyone done a Gage R&R for Spectrophotometer? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
T Has anyone completed the AS9100D Quality Manual transition? Quality Management System (QMS) Manuals 1
D Has anyone taken the AS9100 Delta course / exam? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 37
D Medica show in Dusseldorf - Has anyone else gone? Other Medical Device and Orthopedic Related Topics 3
A AS9100C to D - Has anyone done a gap analysis? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T Has anyone been through the ISO 14001:2015 process? ISO 14001:2015 Specific Discussions 12
M Has anyone had their electronic system scrutinized in an FDA inspection? Records and Data - Quality, Legal and Other Evidence 16
P Has anyone ever heard of the Eastern Weighing and Inspection Bureau? Calibration and Metrology Software and Hardware 1
M Has anyone successfully challenged the new IATF site extension change? IATF 16949 - Automotive Quality Systems Standard 36
R Does anyone know why the TC 176 website has been hijacked by CSA? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
GStough Rx-360 - Has Anyone Used This and What Was Your Experience? Supplier Quality Assurance and other Supplier Issues 3
A Has anyone made an ISO9001:2015 vs. ISO9001:2008 Matrix ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
I Has anyone read BIP 0115:2014? ISO 13485:2016 - Medical Device Quality Management Systems 5
D ?Pa? Capability Index - Has anyone ever heard of this? Capability, Accuracy and Stability - Processes, Machines, etc. 5
optomist1 Has anyone recently taken the GD&T ASME Y14.5M Certification Exam Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
T Has anyone considered what logic is? Coffee Break and Water Cooler Discussions 23
Jim Wynne Has Anyone Had Trouble with IMDS 8.0? RoHS, REACH, ELV, IMDS and Restricted Substances 17
G Has anyone used shlomo Aviv-lean consultant? Lean in Manufacturing and Service Industries 1
M Has anyone purchased their powerball tickets? 17 May 2013 Coffee Break and Water Cooler Discussions 8
T Has anyone done both Quality and Facility Security Officer (FSO) roles ? Career and Occupation Discussions 8
M Has anyone used SGS as a CB (Certification Body)? Registrars and Notified Bodies 4
R Mix Multi-Site/Individual Certification - Has this ever happened to anyone? Miscellaneous Environmental Standards and EMS Related Discussions 14
B Has anyone used Arena Software Simulation? Process Maps, Process Mapping and Turtle Diagrams 10
C Has anyone used GageWare Software? Quality Assurance and Compliance Software Tools and Solutions 4
M Has anyone used "Paradigm 3" software to Control their Quality or Management System? Quality Tools, Improvement and Analysis 2
Q Has Anyone Heard of Quality University (Online Courses) Training - Internal, External, Online and Distance Learning 2
P Has anyone ever heard of "Quality Gates" (Volkswagen term?) - APQP and PPAP APQP and PPAP 11
A Has anyone tried a DAC (Digital to Analog Converter)? After Work and Weekend Discussion Topics 5
I Has anyone ever heard of Registrar QSRD-International? Registrars and Notified Bodies 36
M Has anyone of you have experience with the World Class Manufacturing system? Lean in Manufacturing and Service Industries 6
K Does anyone has experience with determining if Lubricants and Greases are Food Grade? Food Safety - ISO 22000, HACCP (21 CFR 120) 6
R SOPs in Manufacturing - Has anyone got a management process that works? Document Control Systems, Procedures, Forms and Templates 4
K Has anyone had experience dealing with SEDEX (Supplier Ethical Data Exchange)? Customer and Company Specific Requirements 4

Similar threads

Top Bottom