QUES:
My company is a small startup We want to get proceed into certifications and regulatory approval using a “production equivalent prototype”. This prototype is identical in design to our planned production model (equivalent design controls), however the materials and manufacturing methods of a few of the external enclosure parts will be different. We need to do this because we don’t have the funding to create production molds for these parts and we would rather use cheaper methods/materials to get through regulatory before we invest huge sums of money into production.
My question for you is: If we take this approach and use the pre-production materials for completing regulatory approval do you think we will need submit another 510k when we want to move into higher volume production in the future? We plan on providing test data showing the enclosure still passes 60601-1 (we will get another report done through our test lab), provide data showing performance of clinical function is within tolerance to the production prototype and justify that the production method/materials are better controlled and higher preforming than the production equivalent prototype?
The FDA specifically requires that the product tested for regulatory submission be equivalent to what will be sold, e.g., Design Control 21 CFR 820.30, under (g) Design validation - "shall include testing of production units under actual or simulated use conditions."
Changes in material (and resulting electrical characteristics, biocompatibility issues, etc.), IF they impact safety and effectiveness, require a new 510(k); if validation data shows no new impacts on S and E (see the two Guidance Documents on changes to devices having a 510(k) requiring submitting a new 510(k)) then the test data would be sufficient (retained in your device's DHF, subject to FDA inspection) and no new 510(k) would be required.
Your proposed method carries a high degree of risk on the surface, and its success would be dependent upon solid test / verification and validation data showing at least equivalence if not some superiority. However, since this is an enclosure there would be less safety issues, I'd assume. However, companies do occasionally use short life tooling initially for molded parts, changing to more expensive and durable tooling as market acceptance increases, and usually validation is sufficient to address the S&E issues.
QUES: I think we can justify that the initial device tested for regulatory submission can be considered a “production unit” but it would only be feasible for small scale initial production runs. If our product were to build up demand, we would need to switch to an injected part. We hoped we could do this with an engineering design change with additional, testing, data and documentation as I described below. We would want to avoid having to submit another 510k if we did need to make this modification, but I really can’t see how we would reduce S&E with this change. The high production unit parts would be stronger, have a more controlled production method and have more examples of successful biocompatibility assessments, therefore I think there is little risk that the test data shows a reduction.
My main concern is that FDA would see the production method change and have an issue with that aspect of this design change. Let me know what you think.
ANS: If the only change is from limited tooling to high-volume tooling, it's not an issue. If the change is from thermo forming or similiar to high volume injection molding that should not be an issue that can't be addressed by robust V&V. If that change is coupled with a material change then this is the area of major concern, but can usually be addressed with all necessary test data showing same or better resolution of S&E with the injection molded part. Those two Guidance Documents on changes and the 510(k) do allow for good QSR / V&V data to address the S&E, possibly eliminating the need for a new 510(k) (S&E is what an FDA review of a 510(k) focuses on).
-- jel@jelincoln.com
