501(k) Gap Assessment in Response to Warning Letter

Background

Our client, a large Medical Device company, received a 483 Observation and subsequent Warning Letter from the United States Food and Drug Administration (FDA). The nonconformance cited a failure to establish and maintain a Design History File for each device type, to demonstrate the design was developed in accordance with the approved design plan as required by 21 CFR 820.30(j).

Approach and Solution

A team of 7 ECI Regulatory Affairs specialists was secured to provide the regulatory expertise to review product change records and integrate with the client's regulatory team to address gaps in regulatory documentation where the company failed to maintain supporting documentation for changes to Class II devices.

• 510(k)s were identified by device type and prioritized by product family for potential impact to public health.
• Change records were collected and required a process to integrate files into the client's Quality Management System.

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Comprehensive Action

The ECI team generated a plan to produce gap assessments for each product family to capture the applicable internal documentation (letter-to-file) or account for a change description where a gap existed. Approximately 3900 product change records were evaluated in context of the relevant FDA guidance that existed at the time each change was initiated. Additionally, a cumulative change impact was assessed, where applicable recommendation for a 510(k) submission was determined in some instances.

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Results

ECI provided regulatory affairs expertise to evaluate device changes per the context of FDA guidance documents. The team executed commitments made to the client's 483 Observation and Warning Letter responses.

• 30 product families change documentation was reviewed
• 12 prioritized product gap assessments were produced
• 510(k) submission recommendations were identified, as appropriate