Pre-production samples for Device 510(k) test submissions

Basically all the testing has to reflect what the marketed product will be, at least initially.  Any changes made afterward your company will have to validate.  So if you go from machined plastic to injection molded plastic, you will have to do some of the tests over again to show no change to its effect to the patient, that usually satisfies the FDA. Incidentally, the FDA reviews your / lab test data in the 510(k) that we submit, not actual samples.  We won't be submitting physical samples, just descriptive information - Pictures, drawings, specs, test/lab data/reports, ...

However, the initial product has to be "substantially equivalent"(SE) to the predicate device, the 510(k) or De Novo submission (note:  the FDA has recently encouraged "beneficial iteration" rather than 100% SE (of old technology) per their 510(k) modernization programs - Breakthrough Technologies and STeP (safety improvements)) *.  Differences must be minor in most cases, and all test data must show that they are basically SE, especially in the areas of safety to patient and effectiveness. 

Companies have machined parts out of some plastics, those resistant to crazing / cracking (e.g., polycarbonate...).  Usually they use limited cavity, short-run tooling initially before expanding to multiple cavity, production run tooling, to save costs and allow for some changes.  Changes are usually driven by field data, the FDA does not usually get involved in design issues other than evaluating potential safety concerns, and then, they state their issues, but they don't recommend fixes - that's left to the company.

Change to the product over its lifetime is allowed / encouraged by the FDA, as long as some basics remain the same, e.g., Indications for Use, Safety and Effectiveness issues, operating principles, radical material changes, Cautions / Warnings, and similar, per some Guidance Documents - if those change, then a new 510(k) has to be filed. And all changes must be validated to prove the change did what it was intended to do, without any unintended consequences.  All such change data has to be retained by the company and is subject to FDA inspection.  

A  Contract Manufacturer can themselves subcontract.  However, all parties must adhere to the CGMPs, but the top level company is responsible for ultimate CGMP compliance for the entire supply chain, which is defined in Quality Agreements, contractual arrangements, Purchase Orders, annual internal and vendor audits, QC part inspections, etc.

-- jel@jelincoln.com  04/07/2023

* 510(k) mod program references added 10/13/2023 - JEL