Medical device manufacturing is governed by 21 CFR Part 820 (the international equivalent is ISO 13485). Part 820 requires a great focus on establishing and complying with design requirements. Medical device manufacturers working to comply with Part 820 recognize the time-consuming nature of the record-keeping for Good Manufacturing Practices (GMP). The FDA can audit approaches for GMP at any time with a focus on the alignment between the Device Master Record (DMR) and Device History Record (DHR). In addition, the FDA Adverse Event database contains literally thousands of incidents where device manufacturers have encountered issues due to poor first article inspections.
Medical device manufacturers want to avoid receiving a Form 483 and/or Warning Letter from the Food and Drug Administration (FDA). Form 483 is referred to as “Notice of Inspectional Observations” and it identifies deficiencies in the supplier’s quality system. The detailed evaluation of a part’s features and characteristics is integral to ensuring GMP. Most medical device manufacturers are now creating detailed first article inspection reports as part of complying with Part 820.
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