FDA has auditing guidelines posted on it's web pages for QSR

Marc

Hunkered Down for the Duration
Staff member
Admin
#1
The FDA has auditing guidelines posted on it's web pages for the Quality System Regulation (QSR) that has replaced the old cGMP. From the information I have collected, they are auditing design very closely and they are writing 483s for non-conformities.

http://www.fda.gov/cdrh/drb1.html - FDA Web Site
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
From: Suzanne Fiorino - cardiotech.com
Subject: RE: Medical Audit/Rothkopf/Fiorino

> I am doing some work with a small medical company that follows: ISO
> 9001, EN46001 and FDA's QS regulartions. The company already has ISO
> 9000, a CE mark and FDA approval on 3 of their products. I have
> remotely assisted them with internal audits in the past, but only on
> sections of the regulations. The company now wants an external audit
> of the entire system conducted by a third party (me) before the ISO and
> FDA guys show up again (in Sept.). I have conducted quality system ISO
> audits before but I have never done a GMP audit of a company. I know
> this is the wrong forum, but I couldn't find a GMP 'consultants' help
> group. Does anyone out there know of a group or have a generic
> checklist to build an Audit Plan.
>
> thanks,
>
> Dave

Since the group has a CE mark, they must have been audited by a Notified Body. Ask your client for their NB checklist which should have both ISO 9001 + EN 46001 + any EC directive items (i.e. MDD or AIMD). These are the EC equivalent to the FDA QSR if their product is classified as a med device.
 
D

Don Winton

#3
Marc, Somewhere, I have a copy of the FDA's "guideline" for assessing to the new QSR (reformatted in Word 6.0). Will try to find and forward. By the way, most are correct. The FDA is concentrating on "DESIGN CONTROLS."
Pertaining to the above, just because the unit has a CE mark does not mean thay have been audited by a notified body. That varies with the device "MARKED."

[This message has been edited by Don Winton.]
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
If you e-mail it to me I'll post it in the pdf_files directory and post a link (which is becoming a catch-all drop directory...).
 
Thread starter Similar threads Forum Replies Date
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
lilybef FDA and Biocompatability Testing - Reviewer has requested implantation testing Other Medical Device Related Standards 11
M FDA News FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program Other US Medical Device Regulations 0
B FDA Philippines has no check or balance outside the health department Supplier Quality Assurance and other Supplier Issues 3
Z Has FDA reclassified Electroconvulsive Therapy (ECT)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
P FDA has just released the forms for "Small Business Qualification and Certification" Other US Medical Device Regulations 6
M Has anyone had their electronic system scrutinized in an FDA inspection? Records and Data - Quality, Legal and Other Evidence 16
B Has FDA amended any standards in the 21 CFR Part 800 series? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
N Has the FDA approved Electron Beam for Sterilization of bottles? US Food and Drug Administration (FDA) 1
E Every US state has Medical Device Regulations beside FDA Regulations Other US Medical Device Regulations 11
AnaMariaVR2 FDA has issued three Warning Letters... US Food and Drug Administration (FDA) 13
D Has anyone used ExtraView software in FDA regulated industry? Qualification and Validation (including 21 CFR Part 11) 3
A 510(k) Screening Checklist that the RA has filled out - Is that sheet for FDA use? ISO 13485:2016 - Medical Device Quality Management Systems 2
B Has anyone ever had to submit a DMF (Drug Master File) with the FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
T Definition Human Use (FDA) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
K FDA 510k electrosurgery 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
J FDA notification of address change US Food and Drug Administration (FDA) 2
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
Watchcat FDA will not tolerate fraud…meaning what, exactly? Other US Medical Device Regulations 6
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
gunnyshore Form FDA 3500A MedWatch eSubmitter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Watchcat FDA Webinar Series - N95 Respirators Other US Medical Device Regulations 0
M Off-Label Use - Clarification of FDA Policy US Food and Drug Administration (FDA) 1
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S The US FDA requirements on Disposal of a medical device US Food and Drug Administration (FDA) 1
S FDA Requirements for Medical Device Label Reconciliation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
S FDA's E submitter - For clinical electronic thermometer Medical Device and FDA Regulations and Standards News 6
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 11
A FDA and NB audit of Engineering Drawings in DHF and DMR. Medical Device and FDA Regulations and Standards News 1
D FDA De Novo Cover Letter - What is expected US Food and Drug Administration (FDA) 3
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J Mislabeling - Consider this an FDA notified recall? CFR 806.10 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
O Hospital-Developed, In-House Device - FDA Clearance? Other US Medical Device Regulations 19
D FDA Approved Class II Medical Device? Other US Medical Device Regulations 11
R When does the FDA consider a component a medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
N Risk Management besides mandated FDA requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom