FDA regulations for medical devices distributor in US

I

inquisit

#1
Hi , I'm a QA in medical device agent. I am currently wtiting a Quality manual which would be related to 21 CFR 820 in FDA. Is there a checlist I can follow & keep in mind?
I am completely new to this field of Quality & fda, so the simplest of information , any guiselines would be much appreciated.
Thanks
 
Elsmar Forum Sponsor

GStough

Staff member
Super Moderator
#2
Hi , I'm a QA in medical device agent. I am currently wtiting a Quality manual which would be related to 21 CFR 820 in FDA. Is there a checlist I can follow & keep in mind?
I am completely new to this field of Quality & fda, so the simplest of information , any guiselines would be much appreciated.
Thanks
There are some checklists that you might find helpful in the Post Attachments List (thin green bar in the upper left corner of this page). Here are a couple....

http://elsmar.com/Forums/attachment.php?attachmentid=2557
http://elsmar.com/Forums/attachment.php?attachmentid=8754
 
I

inquisit

#3
That's a good start & lot of information to go through. I guess I'm on my way now.
Thanks a lot. I"ll probably have more questions later.
 
Thread starter Similar threads Forum Replies Date
N Per the FDA regulations can a medical device be class I despite that it is sterile? Other Medical Device Related Standards 4
R How to keep track of all FDA rules and regulations for medical device companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M FDA Considers Shift on Medical Device Quality System Regulations - 2018 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
M US FDA Medical Device Distributor Regulations US Food and Drug Administration (FDA) 6
E Every US state has Medical Device Regulations beside FDA Regulations Other US Medical Device Regulations 11
U FDA Regulations related to Medical Device Repair Service US Food and Drug Administration (FDA) 6
Y Does FDA have regulations about Braille use for Medical Device Other US Medical Device Regulations 2
A Medical Device Regulations - FDA Soldering 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
A Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations ISO 13485:2016 - Medical Device Quality Management Systems 11
Marc Problem with 21 CFR Part 820 - US FDA Quality System Regulations (QSR) sub-forum link - 2 May 2019 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
J FDA regulations vs. IEC 60601-1 Labeling Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
alonFAI PCBAs Process Validation Help (Regulations FDA) Manufacturing and Related Processes 2
A Comparing US/FDA Drug Regulations against US/FDA Device Regulations US Food and Drug Administration (FDA) 3
A Using Regulations.gov to Submit Comments on FDA Guidance Documents Other US Medical Device Regulations 5
Ajit Basrur FDA Loosens Pharmaceutical Regulations on 13 Companies Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
O Comply with 21 CFR 11, but no other FDA regulations? Qualification and Validation (including 21 CFR Part 11) 4
S What are the stages in issuance of FDA Regulations? US Food and Drug Administration (FDA) 5
E Label Regulations mandated by China FDA China Medical Device Regulations 5
W FDA Regulations for Research and Development US Food and Drug Administration (FDA) 10
A FDA - Labeling and Advertising Regulations Other US Medical Device Regulations 3
R Always Internal Audit all Line Items of applicable FDA Regulations? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A FDA Labeling Regulations - 21 CFR part 801.109(c) vs (d): Prescription Labeling Other US Medical Device Regulations 5
J Guidance on how often company SOPs need to be reviewed per FDA Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
K Equivalent role of QP (Qualified Person) in FDA Regulations Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
Q Software Validation - FDA Regulations and Requirements US Food and Drug Administration (FDA) 4
Q Do FDA Laser Regulations Apply to Components? US Food and Drug Administration (FDA) 1
R Record Retention Requirements per FDA 820 Regulations Records and Data - Quality, Legal and Other Evidence 10
G All FDA Regulations in a New Easy Download Format US Food and Drug Administration (FDA) 1
E FDA New Product Introduction Regulations help needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
AnaMariaVR2 SOP (Standard Operating Procedure) Controls under FDA Regulations US Food and Drug Administration (FDA) 3
T Am I subject to FDA regulations in Europe? Sales/service branch of an organization US Food and Drug Administration (FDA) 3
Q FDA's Unique Device Identification, New Regulations - Pending March of 2010 ISO 13485:2016 - Medical Device Quality Management Systems 3
H What are the requirements of traceability in FDA's Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
P MSDS for MVQ FDA White, Vinyl Methyl Silicone Rubber EU Medical Device Regulations 4
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
E FDA 513(g) Cover Letter US Food and Drug Administration (FDA) 5
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13
B New Facility register with FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J FDA regulation on decorative contact lenses Medical Device and FDA Regulations and Standards News 5
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom