Contract Manufacturer 510K Starting Point

M

moderngrinding

#1
We are a contract manufacturer of medical components. We are looking to:

1. Become an FDA registered Device Manufacturer
2. Submit a 510K application for a Class II device

The only reason for number 1 is so that number 2 can happen. I am estimating about 7 months on 510K approval. How long does it normally take to get registered as a Device Manufacturer? Is there a compliance audit? We are already ISO 9001 and ISO 13485 compliant.
 
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R

regork

#2
Re: Contract Manufacturer 510K Starting Point?

In my experience, the review and approval of a 510K by the FDA depends on their backlog, the 510K application you are making (complete, correct, understandable), and comparison to the predict device(s). I have gotten clean 510K applications through in less than 50 days, I have had some take > 120 days. My advice is to find out and open the lines of communication w/ your assigned reviewer to keep the process moving and be responsive to any questions the reviewer has.

After you receive 510K approval, you can begin to market your device in the US. In addition to the premarket approval:

* you will need to design, develop, produce, distribute, service your device using an established quality system that meets the FDA QSR (21 CFR Part 820),
* register your establishment and list your device within 30 days of customers using it.
* you must have established procedures to handle adverse event reporting (see 21 CFR 803).
* you must also make your device labeling meets the requirements in 21 CFR 801 and other labeling requirements specific to your device.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
We are a contract manufacturer of medical components. We are looking to:

1. Become an FDA registered Device Manufacturer
2. Submit a 510K application for a Class II device

The only reason for number 1 is so that number 2 can happen. I am estimating about 7 months on 510K approval. How long does it normally take to get registered as a Device Manufacturer? Is there a compliance audit? We are already ISO 9001 and ISO 13485 compliant.
Hi there,

The advice you got from regork is generally true, however please note that the applicability of various requirements depends on you device's ProCode (FDA 3-letter code). Some of the requirements ("General Controls") apply to all devices regardless of code. Normally your code would be identical to your predicate's. Once you have the code sorted, go to its webpage and see what the requirements are, beyond the general controls.

No, normally there's no initial compliance audit. That would typically take place according to FDA's schedule and priorities, and could take quite a while. Given that you already have ISO 13485 cert, you could submit under the VARSP program and delay your first audit significantly. Please note that while 21 CFR 820 is similar to 13485, it's not identical and you're likely to need some adjustments. The extent to which part 820 compliance is required depends on your ProCode (when the FDA say GMP or cGMP in the medical devices context, it means part 820).

Cheers,
Ronen.
 
Last edited:
A

Anoopnest

#8
For Medical Hardware Projects, What are the Hardware artifacts (Documents) required for 510(k) submission?
 
A

Anoopnest

#10
Hi,

Thank for the immediate reply. I already verified the FDA website link that you have provided. But the point noticed that, it is mostly addressing the software artifacts ( please refer the attached doc). Like that can you give the list hardware docs required for 510(k) submission?

Hope you understand my query.

Regards,
Anoop
 

Attachments

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H 510k with Contract Manufacturer Other US Medical Device Regulations 2
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
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
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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
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R 21 CFR Part 820 Contract Manufacturer of Medical Device Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
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J Medical Devices sourced from Contract Manufacturers - Who is the legal manufacturer? EU Medical Device Regulations 13
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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
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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
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N FDA - Change of Manufacturings Site to Contract Manufacturer in China 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
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
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I Implant Raw Material Supplied from Customer to Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
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R Role of Contract Manufacturer - MDRs (Medical Device Reporting) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10

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