Is there a regulatory requirement for clinician review for pFMEAs?

QuinnM

Involved In Discussions
#1
Hello –

We are a medical device company. We just added a new risk to our pFMEA, new revision G. When reviewed, I noticed the previous pFMEA revisions have never been reviewed by a clinician. Is there a regulatory requirement for clinician review for pFMEAs?

QuinnM
 
Elsmar Forum Sponsor

Jean_B

Trusted Information Resource
#3
As Marcelo states there is no requirement for clinicians to review or approve a process FMEA.

This is also (mostly) lgoical, as the clinician would not be providing expertise related to any of the process' inputs, processing or output risks.
Usually a risk of the process has an influence on the device, and may result in a failure mode of the device occurring. For these failure modes of the device (which may impact a patient through some foreseeable sequence of events) it is logical to have a clinican involved to assess them.

Beware though if you have a company doing process FMEA's whose effects stretches all the way to user/patient harm. (These are both burdensome to keep up-to-date and hard to maintain and read).
 
Thread starter Similar threads Forum Replies Date
K Regulatory requirement of SaMD with machine learning component IEC 62304 - Medical Device Software Life Cycle Processes 2
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 1
T Regulatory Standards & Certification Requirement - Headband to monitor mental health Other Medical Device Regulations World-Wide 4
chris1price Is there a regulatory (MDD, MDR, FDA, ISO, etc) requirement to perform a mock recall? CE Marking (Conformité Européene) / CB Scheme 4
R ISO 13485:2016 - Quality Objectives Regulatory Requirement Examples ISO 13485:2016 - Medical Device Quality Management Systems 1
R Medical Device Smartphone App Regulatory Requirement and Labeling US Food and Drug Administration (FDA) 1
V FDA regulatory requirement on the lot number convention for medical devices US Food and Drug Administration (FDA) 2
E Is there a specific regulatory requirement for 100% inspection of IFUs? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
J What to be reported on "New or Revised Regulatory Requirement" at Management Review? Management Review Meetings and related Processes 8
G US Risk Assessment OH&S Regulatory Requirement(s) Occupational Health & Safety Management Standards 5
C Regulatory Requirement Updates? Medical Device Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 6
C What is the Minimum Regulatory Requirement for Record Retention of DHR by Suppliers Records and Data - Quality, Legal and Other Evidence 9
N Statutory and regulatory requirement examples in metal fabrication Various Other Specifications, Standards, and related Requirements 8
G Regulatory requirement for Receiving Inspection reporting to Quality Org.? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Keeping prototype devices - Is there a regulatory or compendial requirement? ISO 13485:2016 - Medical Device Quality Management Systems 3
L Are Fireproof Cabinets a Regulatory Requirement for record storage? FDA or EU Records and Data - Quality, Legal and Other Evidence 23
R Ethics: Ethical Question - Knowingly Violating a Regulatory Requirement Philosophy, Gurus, Innovation and Evolution 20
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
D Worldwide Regulatory Knowledge Other Medical Device Regulations World-Wide 3
JoCam Rental, service & installation - regulatory requirements EU Medical Device Regulations 2
R Regulatory Affairs Certification (RAC) prep - Practice test versus actual exam Professional Certifications and Degrees 0
K Regulatory Affairs Certification (RAC) Exam - November 2020 preparation Professional Certifications and Degrees 0
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
A Regulatory requirements for electrical cosmetic appliances US Food and Drug Administration (FDA) 5
Watchcat Best Regulatory Oversight for Off-Shore Device Manufacturing? Other Medical Device Regulations World-Wide 1
S RA (Regulatory Affairs) certification & Online Internship Professional Certifications and Degrees 11
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 17
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 4
S Regulatory job in pharma vs. medical device US Food and Drug Administration (FDA) 16
S Regulatory job in pharma vs. medical device CE Marking (Conformité Européene) / CB Scheme 0
M Regulatory clearance pathways for surgical masks/N95 respirators Other US Medical Device Regulations 3
N "Placing on the market" & "putting into service"- one time regulatory event or Continual supply event? EU Medical Device Regulations 2
P MDR PRRC (person responsible for regulatory compliance) and personal liability EU Medical Device Regulations 2
Watchcat Year of the Regulatory Watchcat Other US Medical Device Regulations 6
W Updated EU MDR regulatory matrix wanted ISO 13485:2016 - Medical Device Quality Management Systems 43
S SOPs applicable for Regulatory Affairs department Other ISO and International Standards and European Regulations 1
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
Ronen E Legal counselling and Medical Devices Regulatory Affairs Other Medical Device Regulations World-Wide 2
A Help establishing regulatory requirements - Plastic dental cartridge syringe US Food and Drug Administration (FDA) 0
S Regulatory strategy for Third party plugin in a PACS EU Medical Device Regulations 1
S Regulatory Medical Device PMA Plans US Food and Drug Administration (FDA) 2
M Informational TGA – Australian regulatory action on breast implants and breast tissue expanders Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs Medical Device and FDA Regulations and Standards News 2
M Informational CDRH’s Regulatory Science Priorities Medical Device and FDA Regulations and Standards News 3
M Informational IMDRF draft document – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews Medical Device and FDA Regulations and Standards News 0
D What foreign language proficiency would give the biggest edge to medical device regulatory affairs professionals in the world today or in future? Career and Occupation Discussions 6
M Informational Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2018 to 2019 Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF Consultation – Personalized Medical Devices – Regulatory Pathways Medical Device and FDA Regulations and Standards News 0
M Informational EU – MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.22 (05-2019) Medical Device and FDA Regulations and Standards News 2

Similar threads

Top Bottom