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FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. use in education, construction, art, and jewelry). products intended for medical purposes).

Medical 98
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FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. use in education, construction, art, and jewelry). products intended for medical purposes).

Medical 75
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FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

FDA Law

See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. By Steven J. Gonzalez & Lisa M. SCH : LDT, approved by NYS CLEP. It should be noted that 21 CFR 803.18(b)(1)(ii)

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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 820.198).

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Direct-to-consumer advertising distorts prescription drugs’ benefits and costs

Common Sense Family Doctor

He argued that "the pharmaceutical industry should concentrate its efforts on educating physicians about its new products, not coercing patients to put pressure on physicians to make decisions that may not be necessary, beneficial or cost-effective." Kennedy, Jr.’s s previously stated intention to ban DTCA from television.