Contract Manufacturers, Compliance, Selection, and the FDA 

The FDA seldom gets involved in contract manufacturer selection.  They hold the top manufacturer responsible for selection and auditing to ensure they meet requirements. 

The key point the FDA focuses on is the part's specification, and thing they are most concerned with is that the part meets the specification  (print, material, method or manufacture, QC requirements, etc) . They require that you rank supplier by patient risk of the item they supply and document selection and periodic inspection / auditing.  

If the supplier's quality becomes unacceptable, they expect the company to have the systems in place to find that and resolve it, much under CAPA (Corrective and Preventive Action).  

Your choices of supplier should be ranked much as follows (1 is best):

1. FDA / CGMP, 21 CFR 820 compliant, and inspected by the FDA,

2.  ISO 13485:2016 compliant, and audited by a Notified-body;

3.  ISO 9001:2015 compliant, and audited by a Notified-body; 

3.  Actively working to be compliant in 1, 2 or 3;

4.  Know the basics of 820, or ISO 13485, or ISO 9001, especially change control, and willing to become compliant.   

Ultimately you should have a Quality Agreement on CGMP compliance signed by the selected company and yours.  

And the above will have to be defined by SOP, and with records to prove compliance.

-- jel@jelincoln.com

Added supplier to para 4.  JEL 05/12/24 

 Use of Recycled Material In New Device Builds

From the Q&A on a webinar I conducted on Device changes and the 510(k):

Answer to reprocessing / recycling:

1. Reprocessing is the taking of a used single use device and disinfecting, testing, repairing, cleaning, repackaging / relabeling and resterilizing  that SUD for reuse.  Usually done by a 3rd party reprocessor under the reprocessor's 510(k) to allow that;

2. Recycling could be the incorporation of used material in a new build.  I used the example of plastic regrind, but it could be corrugate shipper's using recycled cardboard, or recycled metal used in a part / component, etc. In such instances the company would have to make decisions based on patient risk (ISO 14971:2019), and V&V against the part specification. If the part using recycled raw material meets spec, then it should meet CGMPs. Use of regrind and recycled corrugate are accepted in the device industry - final decision here is based on cost, cost of the regrind / corrugate, vs cost of additional testing / monitoring, if an issue. 

What are other companies doing?  The "c" in CGMP.   

Risks:

o  Unknown provinence / history of the recycled material; missing "documentation" needs to be addressed by filling in the gaps with new documentation based on data;

o Unknown number of times the recycled material has had a portion of it recycled:  

o  The introduction of extra material / particulate during handling / introduction of recycled material and cleanness of the recycled stock; e.g., black specs, other particulate / scrap; 

o Potential weakness of the resulting part using recycled material, compared to part using virgin material; caused by the extra processing and particulate introduction, et al;

Use of recycled subassemblies: I would tend to question its usage at all as that gets into the definition of a new vs used device.   

Also check with your legal department, e.g.,   How would this use affect the outcome of a jury trial involving the malfunction of a device having recycled materials.

See FDA Guidance on use of recycled material in food contact applications:  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-use-recycled-plastics-food-packaging-chemistry-considerations

I couldn't find any specific device information on the FDA's website on the above. 

Another follow-on point:

Rework of a failed / non-conforming new part / component is addressed the CGMPs, requiring dispositioning per SOP and usually by a Material Review Board, defined in a rework Work Order, supported by test / verification data if necessary, and reviewed/approved by Engineering, maybe R&D / others, and QA

-- jel@jelincoln.com