Medical Device & Diagnostic Industry

Regulatory

Outlook

3%

17%

3%

77%

First FDA Inspection

Official Action Indicated (OAI)

Voluntary Action Indicated (VAI)

No Action Indicated (NAI)

Figure 5. CDRH BIMO warning letters by

prior inspection classification.

comprehensive plans to comply with the law. The warning letter response is a critical component of the regulated research entity’s continuous quality improvement process. It also provides the foundation upon which the entity will make corrections and propose preventive actions to minimize or eliminate recurrence. Regulators look closely at these responses to ensure that appropriate remedial measures are planned and implemented within

reasonable timeframes. Some device research entities prepare adequate responses for themselves and their clinical sites by using a corrective and preventive action (CAPA) approach that is similar to the one used for their finished-product quality system. CAPA strategies include the following:

• Assess root cause of the problem.

• Evaluate extent of the problem.

• Implement corrective actions.

• Propose preventive actions to minimize recurrence.

• Include supporting documentation for actions.

• Include timelines for implementation of actions.

Our data suggest that regulated entities need to improve their warning letter responses. For example, CDRH BIMO received inadequate first responses to warning letters from more than half of those regulated entities that received letters in FY 2007 (see Figure 6). When we looked further

55%

45%

Yes No

Figure 6. Percentage of adequate re-

sponses to CDRH BIMO warning letters

in FY 2007.

into our data, 66% of the sponsors that received warning letters had an inadequate first response, and 60% of the clinical investigators had an inadequate first response. In most cases, the responses lacked proper remedial actions or documentation to support such actions. Inadequate responses may waste valuable time and money as

WANT MORE DETAILS? READ AN EXPANDED VERSION OF THIS ARTICLE AT devicelink.com/mddi/warning_letters

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