As of March 29th, 2019, FDA has issued two draft guidances relevant to inspections of domestic and foreign medical device establishments.

The first, issued by FDA’s CDRH in February, identifies a new standard mechanism for device establishments to request nonbinding feedback on actions proposed to address FDA Form 483 observations.

The second, issued by FDA in March, seeks to implement uniform processes and standards for FDA inspections of domestic and foreign device establishments.

Below, we’ve summarized the key takeaways from both of these draft guidances along with general advice for contextualizing and considering action.

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In September of 2018, FDA's CDER published and implemented a new Manual of Policies and Procedures (MAPP) describing the Site Selection Model (SSM) used to prioritize manufacturing sites for routine CGMP surveillance inspections under the Agency's 'risk-based' approach.

As stated, FDA aims to use this model to make the most effective and efficient use of limited resources in an increasingly global manufacturing industry.

According to the Inspection MAPP, while FDA has officially used a 'risk-based" approach for prioritizing pharmaceutical drug manufacturing inspections since FY2005 (which was codified in 2012 with Section 510(h) of the FFDCA, replacing the prior statutory two-year inspection cycle), data from FDA's Inspection Data Dashboard reveals that many establishments are still inspected every two to three years.

This guide offers a clear and simple summary of the background surrounding these policies, what the stated risk factors are, and what FDA-regulated manufacturers can do to prepare based on the information available.

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