Harbor Labs was engaged by a non-US manufacturer of a wearable insulin pump to help resolve a series of disqualifying issues in their 510(k) submission. The manufacturer had already submitted their package to the FDA for review, but had been rejected due to several deficiencies related to their cybersecurity content and test reports.

As a foreign manufacturer unfamiliar with the nuances of the FDA cybersecurity review process, and despite feedback from the reviewer on the deficiencies in their submission, the client was still uncertain how best to remedy these deficiencies in a way that would meet regulatory approval. Moreover, the client was facing schedule pressures and it was imperative that their submission package be redone immediately.

Harbor Labs began the engagement with an extensive gap analysis, reviewing the client’s documentation to identify misordered or mislabeled content, and to note any required content that was absent. Upon completion of the gap assessment, Harbor Labs produced a checklist of tasks to be completed prior to resubmission, including a revised risk assessment and threat model, the production of new architectural views, and a new set of penetration and vulnerability testing. Harbor Labs was engaged to perform a complete overhaul of the submission, reproducing the entirety of all required content.

The client submitted their revised package to the FDA and received 510(k) clearance and authorization to sell in the US market almost immediately.