https://www.jbrplas.com/tags/fda/ Recent content in FDA on JBRplas Hugo en-US Wed, 15 Jan 2025 00:00:00 +0000 https://www.jbrplas.com/posts/medical-grade-injection-molding-fda/ Wed, 15 Jan 2025 00:00:00 +0000 https://www.jbrplas.com/posts/medical-grade-injection-molding-fda/ <p>Sourcing plastic injection-molded components for a medical device is fundamentally different from sourcing industrial parts. The stakes — patient safety, regulatory approval, product liability — demand a different level of rigor from both the buyer and the supplier. This guide covers what medical device OEMs and their supply chain teams need to understand before selecting a plastic molding supplier.</p> <h2 id="what-fda-compliant-actually-means-for-molded-parts">What &ldquo;FDA Compliant&rdquo; Actually Means for Molded Parts</h2> <p>&ldquo;FDA compliant&rdquo; is a term that gets used loosely. For plastic injection-molded components used in medical devices, compliance typically refers to one or more of the following:</p>