{"id":35362,"date":"2026-02-24T09:11:55","date_gmt":"2026-02-24T08:11:55","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=35362"},"modified":"2026-02-24T10:16:43","modified_gmt":"2026-02-24T09:16:43","slug":"compliance-program-7382-850-what-to-expect-from-the-new-fda-inspections","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2026\/02\/24\/compliance-program-7382-850-what-to-expect-from-the-new-fda-inspections\/","title":{"rendered":"Compliance Program 7382.850: what to expect from the new FDA inspections"},"content":{"rendered":"

On February 2, 2026<\/strong>, the U.S. Food and Drug Administration issued the Compliance Program Manual 7382.850<\/strong><\/a>. The comprehensive document serves as an operational guide for FDA personnel (Field and Center staff) to conduct inspections and enforcement activities, while at the same time acting as a strategic resource for medical device manufacturers, providing transparency on the methodologies and criteria the FDA uses when inspecting manufacturers and importers of medical devices<\/strong>, both in the United States and internationally.<\/p>\n

This program consolidates and updates previous protocols, fully replacing both CP 7382.845<\/strong> (commonly known as QSIT) and CP 7383.001<\/strong> related to PMA inspections. The manual applies to the new Quality Management System Regulation (QMSR<\/strong><\/a>)<\/strong>, effective February 2, 2026, which replaced the previous Quality System Regulation (QSR, 21<\/strong>\u202fCFR Part 820)<\/strong> and incorporates by reference the international standard ISO 13485:2016<\/strong>.<\/p>\n

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Key Points in QMSR Evaluation<\/strong><\/h3>\n
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  1. A Paradigm Shift: From \u201cIsolated Subsystems\u201d to TPLC<\/strong>
    \nThe new CP 7382.850 marks the definitive move away from evaluating isolated subsystems, typical of the previous QSIT model. The FDA now adopts the Total Product Life Cycle (TPLC)<\/strong> approach: inspections become an integrated assessment<\/strong> that follows the product throughout its entire life cycle, ensuring that design, manufacturing, and post-market processes are interconnected.<\/li>\n
  2. Focus on Risk Management<\/strong>
    \nRisk management is no longer limited to the design phase<\/strong> but must involve the entire quality system, from purchasing to production, through post-market activities, including cybersecurity, which is particularly relevant for \u201ccyber devices\u201d<\/strong> under Section 524B of the FD&C Act. Inspectors will verify that daily operational decisions are effectively guided by risk analysis<\/strong>.<\/li>\n
  3. Increased emphasis on Post-Market Data<\/strong>
    \nPost-Market Surveillance plays a key role in evaluating the effectiveness of the quality system. It includes complaint handling, the collection and analysis of post-market data, and mandatory reporting under federal regulations. Key sources of information include:<\/li>\n<\/ol>\n