New to RA: FDA Regulation Checklist/Gap Analysis

fondantcookie

Starting to get Involved
#1
Hi all,

I'm relatively new to RA but worked within IVD manufacture for nearly 10 years.

I work for a medical devices company and I've been tasked with leading a gap analysis of our quality management system against the FDA regulations (CFR 820 Part 21?), in preparation for us applying for FDA registration.

Do any of you have a good starting point for this for example a checklist? Or some sort of comparison against ISO13485?

ANY advice would be greatly appreciated at the point.. just wandering in the dark at the minute. Haha

Cheers,
Peter
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
Hi Peter,
Have a look at the following thread:
Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820

It should certainly get you started.
Eventually you will need to go over your ISO 13485 compliant SOPs and compare them to 21 CFR part 820 requirements.

When time comes to do the internal audits I suggest you bring in an external auditor to check your QMS for compliance with US regulation as well.


Cheers,
Shimon
 
Thread starter Similar threads Forum Replies Date
Sidney Vianna FDA plans to use ISO 13485 for Medical Devices Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
H FDA product code and regulation number Other US Medical Device Regulations 3
M Is an R&D company subject to FDA regulation when licensing and not manufacturing? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
S FDA releases Updated Laser Products Regulation Other US Medical Device Regulations 1
R New Saudi FDA Rules and Regulation for Medical Devices Other Medical Device Regulations World-Wide 2
B Guidance Document or Regulation Reference for Scanned Signatures (FDA/EMEA) US Food and Drug Administration (FDA) 4
Michael Malis FDA and LDT Regulation - What is the latest status on LDT Regulation US Food and Drug Administration (FDA) 3
I ISO 13485 and FDA 21 CFR 820 Regulation - Writing my QA Manual ISO 13485:2016 - Medical Device Quality Management Systems 2
Michael Malis The FDA proposes to amend the combination product regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Ajit Basrur FDA Issues Final Regulation on Dental Amalgam 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
M The FDA says device regulation will move toward harmonization... 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
A FDA Regulation Training Materials Other US Medical Device Regulations 5
GStough FDA QSR (Quality System Regulation) Training Needed in the Southeastern USA Training - Internal, External, Online and Distance Learning 7
R FDA Part 820 Quality System Regulation - 820.198 Complaint files ISO 13485:2016 - Medical Device Quality Management Systems 20
S Documents / Following Procedures - FDA 21 CFR Part 820 Quality System Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
A FDA will not make a company comply with a regulation if it causes undue hardship ISO 13485:2016 - Medical Device Quality Management Systems 2
H Definition Human Use (FDA) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
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

Similar threads

Top Bottom