FDA Sub contractor Requirements

#1
Hello all,

I currently work as the quality engineer for a (ISO 9001) company that primarily produces plastic products for the retail display market, although we do produce other plastic related items.

We have just taken on a contract to manufacture transfer boards (basically a flat plastic board used to help individuals move from bed, chair etc to a wheelchair).

This product is classed as a medical device and, because our customer sells to the USA, we have been told we need to be FDA certified.

I have worked for an FDA certified company before, but I have never been in the position where I have to apply and manage the system required.

I have done the usual research and have read through several "Title 21" documents, but it can get a bit confusing.

Is there anyone out there who can give me some pointers on how to progress this?

Do we actually need FDA approval ourselves if we are supplying to a UK company, regardless of the fact that it is there decision to export to the USA?

If it is the case that we do need approval, how valid is our ISO 9001 certification? does it cover us?

Any guidance (or help on where to look) would be appreciated.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Moderator
#2
Why the sad face?... :)

Do we actually need FDA approval ourselves if we are supplying to a UK company, regardless of the fact that it is there decision to export to the USA?
“FDA approval” is not the best term for what you’re asking. I guess the relevant question would be what actions you need to take to meet FDA requirements that apply to you. The answer depends on what you make. Is it the finished / the whole product (device), or is it just a component to be included in an assembly / further processed etc.? If just a component, you don’t have direct obligations towards the FDA. Your client might, though, so they need to study their position thoroughly, and then they might pose some specific requirements to you (eg via contract or purchase order) to support their endeavour to comply. Then, your job would be to make sure what they require is reasonable to you, considering the business value as you perceive it. If, however, you manufacture a finished device for your client you might qualify as a Contract Manufacturer in FDA terms. You can read about CM obligations on the FDA website. The specifics depend on the device classification - the easiest way to classify is to identify an identical (or very similar) device already on the US market, and look up its classification on the FDA database.

Give us a shout if you get stuck.

If it is the case that we do need approval, how valid is our ISO 9001 certification? does it cover us?
Unfortunately its almost useless, except the fact that it means you already have an up-and-running QMS. Where QMS requirements apply under the FDA, the binding reference is 21 CFR 820 (which is close, but not identical, to ISO 13485).

Cheers,
Ronen.
 
Last edited:
Thread starter Similar threads Forum Replies Date
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
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
R FDA - How to discontinue/obsolete medical devices that share sub-components with others that will still be distributed Other US Medical Device Regulations 5
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
Ajit Basrur New sub-forums within the FDA forum US Food and Drug Administration (FDA) 11
D FDA Audit - who is "eligible"? Medical Device Sub-Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 20
Y Convenience pack FDA US Food and Drug Administration (FDA) 1
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
N FDA medical devices US Food and Drug Administration (FDA) 1
R US FDA 510k Australia TGA US Food and Drug Administration (FDA) 0
B How FDA define a new variant/generation or a new device US Medical Device Regulations 11
G FDA Annual Registration and Listing US Food and Drug Administration (FDA) 7
T Book Excerpt: Drugs and the FDA: Safety, Efficacy, and the Public’s Trust Book, Video, Blog and Web Site Reviews and Recommendations 0
E The FDA regulations (21 CFR 312.3): Is it allowable that IND sponsor involves more than one individual or organization? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
P Looking for Korean FDA Drug Master File requirements for packaging systems. Other Medical Device and Orthopedic Related Topics 1
M IEC 62366 Hazard-related Use Scenario vs FDA Critical Task EU Medical Device Regulations 3
N Free sale and FDA US Food and Drug Administration (FDA) 1
N FDA class 1 US Food and Drug Administration (FDA) 6
G UDI in EU vs FDA EU Medical Device Regulations 1
S Initial Audit FDA US Medical Device Regulations 3
T FDA PMA review process - advisory panel timing? Other Medical Device and Orthopedic Related Topics 0
E FDA & Internal Audits US Medical Device Regulations 3
N Importing into US without 510K/FDA Clearance US Medical Device Regulations 1
N FDA class 2 Device QS Requirements US Food and Drug Administration (FDA) 2
T FDA labeling requirements US Food and Drug Administration (FDA) 2
S FDA Contract Manufacturer and Applicant US Food and Drug Administration (FDA) 0
R IVD Software FDA/CLIA doubts Medical Device and FDA Regulations and Standards News 1
R IVD software FDA and CLIA US Food and Drug Administration (FDA) 2
T FDA level of concern vs IEC 62304 safety classification - 510(k) exempt device Other US Medical Device Regulations 13
K Change in address on ERLM US FDA: Implications to import US Medical Device Regulations 0
V FDA 510K - Pre Submission Query US Food and Drug Administration (FDA) 6
M Document Control ISO and FDA ISO 13485:2016 - Medical Device Quality Management Systems 7
C FDA 510k documentation requirements US Food and Drug Administration (FDA) 1
T Link GMDN code and FDA product code US Medical Device Regulations 5
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
M How does FDA determine OAI and VAI after inspection? ISO 13485:2016 - Medical Device Quality Management Systems 0
K Non-Device MDDS Clarifications (FDA) US Food and Drug Administration (FDA) 7
Ed Panek Consultant Request SaMD AI "Expert" FDA US Food and Drug Administration (FDA) 2
Sam Lazzara Record signature requirements in proposed FDA 21 CFR 820 QMS Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
shimonv FDA-recognized Standards US Food and Drug Administration (FDA) 0
R FDA ECG Data Requirements Medical Information Technology, Medical Software and Health Informatics 3
L Language of quality system in case of FDA inspection US Food and Drug Administration (FDA) 1
M Can you import medical device not FDA approved into the USA under an IND application? US Food and Drug Administration (FDA) 2
Ed Panek FDA Submits to White House Plan to Harmonize with ISO 13485 US Medical Device Regulations 2
Melissa Contract Mfg--to Manufacturer with the FDA ISO 13485:2016 - Medical Device Quality Management Systems 4
Ed Panek ANNUAL FDA Registration - What 510(k) number to use? US Food and Drug Administration (FDA) 1
Y FDA vs (EU) 2021/2226 Electronic Instructions for Use (eIFUs) US Medical Device Regulations 1
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
JesseE Electronic signatures FDA CFR 820 ISO 13485:2016 - Medical Device Quality Management Systems 3
C FDA logo for marketing US Food and Drug Administration (FDA) 3

Similar threads

Top Bottom