Circuitwise is pleased to announce it has successfully passed an audit conducted by the US Federal Drug Administration. This audit enables Circuitwise to continue its establishment registration on the FDA’s FURLS database as a contract manufacturing establishment for medical devices.
Any company involved in the manufacturing of medical devices sold in the United State must be registered as an official establishment associated with that product. This applies to the registered manufacturer, any contract manufacturer, specification developer and sterilization provider, among other categories.
Circuitwise first gained Establishment Registration in late 2021. This registration makes it easier for our customers to ship finished devices directly from Circuitwise to US market. For new devices/customers, it is as simple as adding another line to the existing device listing. As part of that commitment, the FDA could choose to audit Circuitwise at any time. That time came a few months ago and the quality team at Circuitwise was subjected to a rigorous audit by a US audit team.
We just received confirmation that we passed easily with minor observations. The audit criteria were based on 21 CFR 820. The audit scope was the entire manufacturing process and not just the listed product.
This standard is similar to the medical devices quality standard ISO13485, with some minor differences. FDA is updating 21 CFR 820 to better align the stow standards. It said:
“This action continues the FDA’s efforts to align its regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients”
This audit outcome is an independent confirmation of how high our quality management systems are, in particular, our ISO 13485 quality management certification for the manufacture of medical devices.
FURLS is an acronym for FDA Unified Registration and Listing System. It is the system the FDA provides for applicants to register online and make electronic submissions.
Establishments must reregister annually, and this system facilitates easy updates to the information provided. Information updates include listing the range of medical devices a contract manufacturer is involved in, that are marketed in the US, and the activities performed.
Establishment registration is a separate process from obtaining regulatory approval for a medical device in the US, typically through a 510(k) clearance or Premarket Approval (PMA).
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