21 CFR 820 vs 21CFR820 vs 21 CFR Part 820

MissTSmith

Starting to get Involved
#1
Hi,
I'm updating a Quality Manual and the associated SOPs.
I noticed inconsistencies, sometimes even within a document (i.e. 2 or 3 pages) where I see:
  • 21 CFR 820
  • 21CFR820
  • 21 CFR Part 820
  • 21CFR 820
So, is there a standard for this? The above is just an example...I'm finding when I go into Google I might get no results for "21CFR123" but do get results for "21 CFR 123"...but the next search of "21CFR555" gives me results but "21 CFR 555" gives me nothing...

Thanks.:modcop:
 
Last edited:
Elsmar Forum Sponsor

monoj mon

Quite Involved in Discussions
#2
I don't think this should be a matter of concern, unless you write the numbers wrong. Grab any random 510(k) summary and you will see that even FDA itself is not concerned about it. Just write it in your documents so that everyone can understand.
but the next search of "21CFR555" gives me results but "21 CFR 555" gives me nothing
By the way, I don't think there is any 21 CFR Part 555! It simply doesn't exists, that's why you aren't getting any search result. Check here
CFR - Code of Federal Regulations Title 21.
 

Ajit Basrur

Staff member
Admin
#4
Hi,
I'm updating a Quality Manual and the associated SOPs.
I noticed inconsistencies, sometimes even within a document (i.e. 2 or 3 pages) where I see:
  • 21 CFR 820
  • 21CFR820
  • 21 CFR Part 820
  • 21CFR 820
So, is there a standard for this? The above is just an example...I'm finding when I go into Google I might get no results for "21CFR123" but do get results for "21 CFR 123"...but the next search of "21CFR555" gives me results but "21 CFR 555" gives me nothing...

Thanks.:modcop:
Its like call a rose by any other name and it would smell as sweet :)

Tagin is correct but its not a concern the way you described your four bullets. To add some spice, here is the fifth one as a "section mark" symbol, 21 CFR § 820.60
 
Thread starter Similar threads Forum Replies Date
A TUV Audits - 21 CFR 820 General Auditing Discussions 6
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13
T 21 CFR 820.20 - Quality Planning Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
R Addressing training requirements - 21 CFR Part 820.25 (1) & (2) Other US Medical Device Regulations 4
R How to improve a Validation program and procedures to FDA (21 CFR part 820) & ISO13485 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
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
R 21 CFR Part 820 Contract Manufacturer of Medical Device Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
N Change Control - Compliance with FDA 21 CFR Part 820 Document Control Systems, Procedures, Forms and Templates 3
D 21 CFR Part 820 (Subpart A) - Question about "Authority" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R RUO audits - CFR 820.22 and ISO 13485 8.2.4 Internal Auditing 3
A Training as well as certifications for ISO 13485:2016, 21 CFR 820... Training - Internal, External, Online and Distance Learning 5
K Production Unit Labeling - 21 CFR 820.184.e 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R 21 CFR Part 820.186 - Types of Quality System Records Document Control Systems, Procedures, Forms and Templates 1
M Does the Scope of 21 CFR Part 820.72 (Equipment) apply to Design? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
V 21 CFR 820 Compliant way to use Kaizen to address Nonconformances Nonconformance and Corrective Action 9
C 21 CFR Part 820.184 - Label Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
shimonv 21 CFR 820.20(d) says: Each manufacturer shall establish a Quality Plan 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
V Upgrading Systems from CFR 211 to CFR 820 (drug+device combination) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 14
Q Internal Audit of Product Quality Complaint System (21 CFR Part 820) Customer Complaints 9
R Managing Employee Training Files - 21 CFR Part 820.25 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Release authorization before or after packaging per 21 CFR 820.80(d)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Need advice in streamlining antiquated 21 CFR 820 compliant QMS Quality Manager and Management Related Issues 2
J Minimum staff per 21 CFR Part 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Does a process map satisfy 21 CFR 820.20(d) (Quality Plan)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Calibration of processing equipment - 21 CFR 820.70 Production and process controls 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Issues with UDI additions to 21 CFR 820 requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Interpreting Process Controls - 21 CFR Part 820.70(a) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S How others have defined "reaudits"? 21 CFR Part 820.22 Internal Auditing 1
M FDA 21 CFR 820.250 - Does "valid statistical" always mean math? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
J Document Control Features (Document Content Requirements) and 21 CFR 820.40 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S 21 CFR Part 820.40(b) Clarification on Required Document Approvers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
R Where to find 21 CFR Part 820 Translated into Czech, Spanish, and German 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
N Certificate of Compliance from a Sister Company for FDA 21 CFR 820 Exemption 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Does FDA expect suppliers to be independently assessed to 21 CFR Part 820 ? US Food and Drug Administration (FDA) 4
A Effective Date (of Documents) issue outlined in 21 CFR Part 820.4 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
L Mobile Medical App - Understanding 21 CFR Part 820 Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T "Special Process" Validation Requirements (21 CFR Part 820) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
Y ISO 13485:2003 &FDA QSR (21 CFR 820) Quality Manual,34 Procedures and Form Book, Video, Blog and Web Site Reviews and Recommendations 8
R Policy Statement for FDA CFR 820 Acceptance Activities of Incoming Products. Other US Medical Device Regulations 1
shimonv Storage of finished medical devices per 21 CFR Part 820.150 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
M Does 21 CFR 820.80 (b) require a Supplier to have Receiving Inspection? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
I Does being a subsidiary fully absolve company B from complying with 21 CFR 820? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Help me understand the applicability of 21 CFR Part 820.198 (Customer Complaints) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A Do controlled documents require a signature on every page as per 21 CFR 820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
P Internal Audit Reports reviewed by management? 21 CFR 820.22 Interpretation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6

Similar threads

Top Bottom