Avoid FDA 510(k) Resubmission Through Licensed Manufacturing
Ensuring uninterrupted medical device production while preserving form, fit, function, and regulatory compliance
The Customer Challenge
A leading medical device manufacturer producing an FDA Class II infusion pump system faced a critical supply chain challenge when a legacy Philips 8bit microcontroller, integral to the system’s architecture, was discontinued. The manufacturer’s last time buy was insufficient, and no additional authorized inventory was available, creating an immediate risk to production continuity.
Redesigning the infusion pump system around a new processor would trigger:
- A complete FDA 510(k) resubmission
- Full software redevelopment and revalidation
- Multi-year verification and validation testing
- Interruption to product availability, significant costs, and regulatory delays
The manufacturer required a solution that would maintain compliance, avoid production delays, and eliminate the need for costly redesigns.
The Rochester Solution
By partnering with Rochester Electronics, the Medical OEM sourced several thousand units of a Rochester-manufactured 8-bit Philips microcontroller produced using original Philips silicon and test programs. Being marked identically to the original device, and ensuring no change in form, fit, or function, allowed the OEM to continue production under its existing FDA clearance, without requiring a new 510(k) submission.
Per FDA guidance, only internal verification and documentation were required, in accordance with design-control procedures (21 CFR 820.30) and purchasing controls (21 CFR 820.50).
All verification records were retained within the manufacturer’s quality system and remain available for FDA audit, confirming that safety and effectiveness were not affected.
As a result, the OEM avoided 510(k) resubmission, redesign and software changes, experienced zero interruption to production, maintained full FDA compliance, and ensured long-term continuity for the active Class II medical device.
This engagement highlights Rochester’s ability to support regulated, long-life industries by mitigating semiconductor obsolescence.
