What body conducts 21 CFR 820 FDA certification?

rvanelli

Involved In Discussions
#1
What body conducts this FDA certification? Is it the FDA or a registrar like in ISO 13485?

I've looked this site over and while there is a lot of information I can't find where to begin this certification process.

Thanks in advance.
 
Elsmar Forum Sponsor
#2
Re: Simple 21 CFR 820 certification question...

Simple answer: nobody actually certifies to the 21 CFR 820, though in practice most firms which certify to ISO 13485 also must address these regulations, and your medical device Customers will almost certainly audit you against 21 CFR 820! (assuming your Customer sells to, or your firm produces devices in, the USA)
 
Last edited:

rvanelli

Involved In Discussions
#3
Re: Simple 21 CFR 820 certification question...

Thanks! i was thinking that might be the case. What about Class III certificates? Is that something you apply for through the FDA?
 

yodon

Staff member
Super Moderator
#4
Re: Simple 21 CFR 820 certification question...

Still no 'certification.' There are 2 ways to enter the (US) market: 510(k) and PMA. I think Class III may require PMA (the more difficult path). The gist is that you submit your data to the FDA and they approve it for sale (or not). They may do site inspections, require clinical trial data, etc. so all that has to be worked out early on. FDA does not "approve" products.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: Simple 21 CFR 820 certification question...

@rvanelli:

Welcome to the Cove. In your situation, if you are looking to get a class III device cleared for marketing in the USA, I strongly recommend hiring someone experienced to walk you through the applicable requirements and process. Many SU companies recruit a regulatory affairs / clinical trials specialist to take care of that aspect; others rely on outsourced consultants. Either way, the most common mistake (and often the most painful in hindsight) is postponing handling this issue "till later". The sooner you begin the more efficient and painless your clearance process will be. Guaranteed.

Good luck,
Ronen.
 

somashekar

Staff member
Super Moderator
#7
Re: Simple 21 CFR 820 certification question...

The US FDA inspects the organization on the lines of the 21 CFR 820 in the QSIT (quality system inspection technique)
There is no certification involved, and no payments to be made. If you have not had one, wait for your turn. Once you are inspected, you will probably have more periodic inspection.
Keep going with the routine inspection process and make it all good to avoid investigation visits ...
Good luck.
 
Last edited:

rvanelli

Involved In Discussions
#8
Thanks everybody for your response.

Our situation is a bit different in that we currently do not have any medical products, although we are ISO 13485 certified, but are looking to grow our diversified business by seeking these types of certifications. We are surrounded by medical companies and are looking for some assembly or logistics type business from some of the local companies.

I appreciate all of the comments and suggestions. :agree1:
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Thanks everybody for your response.

Our situation is a bit different in that we currently do not have any medical products, although we are ISO 13485 certified, but are looking to grow our diversified business by seeking these types of certifications. We are surrounded by medical companies and are looking for some assembly or logistics type business from some of the local companies.

I appreciate all of the comments and suggestions. :agree1:
Hi,

It sounds like you will be becoming (in FDA terms) a Contract Manufacturer of finished medical devices, or a component supplier / service provider. Typically, in these situations both 21 CFR part 820 and product premarket clearance (510k/PMA) will not be directly applicable to you, but to your clients.

Cheers,
Ronen.
 
Thread starter Similar threads Forum Replies Date
Ed Panek Notified Body Substantial Change MDD EU Medical Device Regulations 1
S Certification Body Changeover - Transfer of Certificate Registrars and Notified Bodies 9
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
M Spain Notified Body Medical Device and FDA Regulations and Standards News 0
M Notified Body Spain Other ISO and International Standards and European Regulations 0
M Spanish Notified Body - Spanish language CE Marking (Conformité Européene) / CB Scheme 2
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
B IATF 16949 Cert Expire- New certification body IATF 16949 - Automotive Quality Systems Standard 5
J Intervertebral body fusion cage, MDR Class II or Class III? EU Medical Device Regulations 4
P Notified Body Approval of Change EU Medical Device Regulations 2
M What happens to certifications if the issuing certification body loses accreditation? Supplier Quality Assurance and other Supplier Issues 2
K Adding the Notified Body Number CE Marking (Conformité Européene) / CB Scheme 2
Marc Mule Car aka Body Mule Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 6
A NB (Notified Body) Audit of Standards ISO 13485:2016 - Medical Device Quality Management Systems 3
J Conflict of Interest Registrar/Notified Body/Testing House Quality Manager and Management Related Issues 4
JoCam Certified Body Audit of MDR requirements EU Medical Device Regulations 4
R Change Notification - Registrar vs Notified body ISO 13485:2016 - Medical Device Quality Management Systems 1
Watchcat "Disappeared" Linkedin Notified Body Rant EU Medical Device Regulations 2
M Notified Body audits -Class Ia medical device product EU Medical Device Regulations 4
R Notified Body for MDD 1Q20 - Florida Company Registrars and Notified Bodies 4
M Informational EU – New notified body designated under the MDR – NB 2797 BSI Group The Netherlands B.V. Netherlands Medical Device and FDA Regulations and Standards News 0
M Informational EU – New notified body designated under the MDR – NB 1912 – DARE!! Services B.V. – Netherlands Medical Device and FDA Regulations and Standards News 0
N Customer asking if their notified body can audit us ISO 13485:2016 - Medical Device Quality Management Systems 5
G Is impact test according to IEC 60601-1 applicable for HAND-HELD equipment if also classified as BODY-WORN? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
N MDR review process by notified body - How many steps exist in the review process EU Medical Device Regulations 0
Ed Panek CAPA against Notified Body? EU Medical Device Regulations 5
M Informational EU – First IVDR designated Notified Body – DEKRA Certification GmbH Medical Device and FDA Regulations and Standards News 0
N Regular meetings with Notified Body EU Medical Device Regulations 13
M Informational EU – New designated Notified Body under the MDR – TÜV Rheinland LGA Products GmbH Medical Device and FDA Regulations and Standards News 0
M Informational New designated Notified Body for Regulation (EU) 2017/745 (MDR) included in Nando – IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Medical Device and FDA Regulations and Standards News 3
M Informational EU – Next Notified Body designated to the MDR 2017/475 is IMQ S.p.A from Italy Medical Device and FDA Regulations and Standards News 0
M Informational EU – DEKRA Certification GmbH is the third Notified Body designated under the MDR Medical Device and FDA Regulations and Standards News 0
JoshuaFroud The withdrawal of Lloyd’s Register MDD & IVDD Notified Body Status CE Marking (Conformité Européene) / CB Scheme 1
M Measurement Unit Rounding Nonconformity - Notified Body Audit Registrars and Notified Bodies 6
M Informational From RAPS – Another Notified Body Bows Out Ahead of EU MDR: ‘Investment Too High’ Medical Device and FDA Regulations and Standards News 2
M Authorized Rep (AR), competent authority, NCA and notified body - Differences EU Medical Device Regulations 9
R How long to wait for Notified Body Response - Potentially significant change to a medical device CE Marking (Conformité Européene) / CB Scheme 6
M Informational New Notified Body designated under the MDR – TÜV SÜD Product Service GmbH Zertifizierstellen Medical Device and FDA Regulations and Standards News 1
shimonv Non-significant notice of change to notified body EU Medical Device Regulations 4
J0anne Implantable Devices - The effects of surgical scaffold implanted into the human body Other Medical Device and Orthopedic Related Topics 8
C TL-9000 Certifying Body Issue - Auditor failed to find an issue for 10 years TL 9000 Telecommunications Standard and QuEST 16
S Difficulty Finding A Notified Body for CE Marking - No Capacity Registrars and Notified Bodies 5
M We still have not received our certificate due to a 'backlog' with our auditing body Registrars and Notified Bodies 25
N Creepage - Does a surface mount isolator body negate a PCB slot? IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
P Notified body located in an other country than manufacturing company ISO 13485:2016 - Medical Device Quality Management Systems 2
T Reasons to change certification body and typical costs Registrars and Notified Bodies 16
W IEC 60601-1-2 Susceptibility/Immunity for device intended to be used in patient body IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M BSI – Want to know more about the Notified Body? Registrars and Notified Bodies 0
M Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body Registrars and Notified Bodies 6
W Body-worn brain stimulator (MOPP isolation requirements) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3

Similar threads

Top Bottom