Contract Manufacturer Registering with the FDA - Medical Devices - 21 CFR 807.20

F

Frank34

#1
I received a letter mid 2005 that stated if you "1. are engaged in the manufacture, preparation, or processing of a medical device (21 CFR 807.20(a)), AND" "2. introduce the device into comercial distribution, (21 CFR 807.20(c)); then you are required to register the establishement and submit device listing forms FDA 2891 and FDA 2892 respectively. If you do not put devices into commercial distribution, you should not register your establishement or list your devices."

Has anyone else received this and if so is it really saying to stop registering as a contract manufacturer of medical devices?
 
Elsmar Forum Sponsor

Statistical Steven

Statistician
Staff member
Super Moderator
#3
Frank34 said:
I received a letter mid 2005 that stated if you "1. are engaged in the manufacture, preparation, or processing of a medical device (21 CFR 807.20(a)), AND" "2. introduce the device into comercial distribution, (21 CFR 807.20(c)); then you are required to register the establishement and submit device listing forms FDA 2891 and FDA 2892 respectively. If you do not put devices into commercial distribution, you should not register your establishement or list your devices."

Has anyone else received this and if so is it really saying to stop registering as a contract manufacturer of medical devices?
I believe the FDA will cease the inspection of contract manufacturers, requiring the sponsor to audit and verify acceptable systems. Thought the FDA website still states:

Contract Manufacturers

A person(s) that manufactures a finished device under the terms of a contract with another manufacturer is a contract manufacturer. The agreement between the manufacturers should be documented in a written contract. Contract manufacturers of finished devices shall comply with applicable requirements of the quality system and shall register their establishment with FDA. Depending on the circumstances, both the contractor and manufacturer may be held jointly responsible by FDA for the activities performed.

Sorry I cannot give you a definitive answer.
 

Al Rosen

Staff member
Super Moderator
#4
Maybe you don't have to register.
From Sec. 807.20 Who must register and submit a device list?
(c) Registration and listing requirements shall not pertain to any person who:
(1) Manufacturers devices for another party who both initiated the specifications and commercially distributes the device;
(2) Sterilizes devices on a contract basis for other registered facilities who commercially distribute the devices.
(3) Acts as a wholesale distributor, as defined in 807.3(s), and who does not manufacture, repackage, process, or relabel a device.
 

sreenu927

Quite Involved in Discussions
#7
Hi..
As per FDA regulations:
1. "Contract Manufacturer who commercially distributes the device for the specifications developer – register and list the device."

Here, what do you mean by "commercially distribute for specs developer"?

2. Registration and listing requirements shall not pertain to any person who:
(1) Manufacturers devices for another party who both initiated the specifications and commercially distributes the device; [807.20 (c) (1)]


What does it mean? If the specifications are from A(means, design is owned by A) and B does the contract manufacturing and A sells the product on it's name (label will have A as the manufacturer), then does B needs to register with FDA?

In another case, if B owns the specifications (owns the design) and contract manufactures for A; A being the manufacturer with it's name on the product label, then does B needs establishment registration with FDA? I guess here in this case is YES.

Pls clarify.


Thanks,
Sreenu
 
R

rdesmond

#8
Hello!

As a Contract Manufacturer, we will now be required to register with the FDA. We are a relatively small company; about 25% is MD& only 1 product is causing us to register - the rest are components/

Any suggestions for how to get up to speed on FDA interaction. We have 2 people who previously worked at big MD companies, however no one here really knows what we'd do if the FDA showed up. We've never had a single customer complaint / return so I'd hope that would keep us low on the radar. Thanks a bunch!!
 
M

MIREGMGR

#9
Is your business structured around a QMS that conforms to the FDA GMPs and your customers' requirements?

If so, whoever set that up should be guiding your efforts to become more aware of the 2013 heightened responsibilities.

If not, you might want to consider hiring a consultant to do a gap analysis and get you set up.
 
R

rdesmond

#10
I setup the system & indeed, it is complaint to customer req'ts & 13485; we will be formally registered in 2013. I do not have experience w/ the FDA so therein lies the inquiry.
 
Thread starter Similar threads Forum Replies Date
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 How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
H Obligations as a contract manufacturer during an MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
H 510k with Contract Manufacturer Other US Medical Device Regulations 2
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
M We are looking for a Contract Manufacturer US Food and Drug Administration (FDA) 2
L Sample Procedure from Contract Manufacturer Prospective ISO 14971 - Medical Device Risk Management 1
I Is the contract mfg. mentioned in legal manufacturer EC certificate? CE Marking (Conformité Européene) / CB Scheme 4
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R FCC certification (contract manufacturer) TL 9000 Telecommunications Standard and QuEST 1
M Contract manufacturer MDR Quality Management System (QMS) Manuals 1
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
O Identifying KPI for AS9100 8.1.4 - Prevention of Counterfeit Parts - PCB assembly contract manufacturer AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
M Medical Device Master File - We are a contract manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 7
D Software Validation - Contract manufacturer of Components (PCBA's) Qualification and Validation (including 21 CFR Part 11) 7
J Contract Sterilization - Our company is a contract manufacturer Manufacturing and Related Processes 8
R Contract Manufacturer/OEM Supplier - We are a specification developer for a kitted product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site Other Medical Device Regulations World-Wide 0
L REACH Compliance - Small, family-owned contract manufacturer REACH and RoHS Conversations 16
R 21 CFR Part 820 Contract Manufacturer of Medical Device Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Ed Panek Bringing Production in house from Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 80079-34 certified contract manufacturer needed Other ISO and International Standards and European Regulations 2
Ed Panek Observational Audit of Contract Manufacturer Production ISO 13485:2016 - Medical Device Quality Management Systems 5
S Is it okay to store the design files (device drawings) at contract manufacturer location? ISO 13485:2016 - Medical Device Quality Management Systems 6
M Contract Manufacturer of a Finished Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5
D EU MDR - Contract Manufacturer vs Legal Manufacturer EU Medical Device Regulations 4
I Certificate of Exportability - Contract manufacturer located outside the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Is company “A” a contract manufacturer, a labeler, or a repackager 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Integrating a Contract Manufacturer's documentation into our Quality System ISO 13485:2016 - Medical Device Quality Management Systems 3
J Medical Devices sourced from Contract Manufacturers - Who is the legal manufacturer? EU Medical Device Regulations 13
S Question about ISO 13485:2003 - Production Provisions - Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 10
S Contract Manufacturer Question - Whether or not the reference to the ex-CMO ISO 13485:2016 - Medical Device Quality Management Systems 6
R Sterilization Adoption - Design House - Adoption Letter from Contract Manufacturer EU Medical Device Regulations 3
Ajit Basrur Can a Contract Manufacturer Delist a Device upon Discontinuation of Manufacturing? Other US Medical Device Regulations 1
H Who is the Legal / Labeled Manufacturer? (Contract Manufacturers shipping to the EU) ISO 13485:2016 - Medical Device Quality Management Systems 1
N "Sterile" missing on the CE Certificate - ISO 13485 Certified Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 5
N UDI implementation with contract manufacturer Other US Medical Device Regulations 2
somashekar Pre-Announced FDA 4 Day Inspection, Class 2 Devices, Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
W Shared Responsibility Between Spec Provider and Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Device Master Records for a Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
N FDA - Change of Manufacturings Site to Contract Manufacturer in China 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Contract Manufacturer 510K Starting Point 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
P Process Validation of inherited tooling by Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
N Contract Manufacturer EC Certificate Scope ISO 13485:2016 - Medical Device Quality Management Systems 8
S Does Contract Manufacturer need to issue Food Grade certificate for finished device? US Food and Drug Administration (FDA) 1
S Should a contract manufacturer for components be filing MDR exemption? US Food and Drug Administration (FDA) 1
J Import of an Investigational Device from a Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
R Process Development Requirements for a Contract Manufacturer with no Design Design and Development of Products and Processes 5
I Implant Raw Material Supplied from Customer to Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
P Records authorizing release of product at Contract Manufacturer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2

Similar threads

Top Bottom