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Medical Devices

The U.S. Food and Drug Administration has proposed banning powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder Read more about FDA Proposes Ban on Powdered Medical Gloves

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Is a special DMF required for packaging materials used to package Medical Devices or will a DMF set for packaging materials used for food and drug Read more about What Are the Requirements for Medical Device Packaging?

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Does the label on the primary and secondary pack of a Class I or II device need to comply with the OTC regulation when the device is always Read more about Is There Ever a Time When a Class I or II Device Need not Comply with OTC Regulations on Labeling?

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Does labeling for a Prescription Medical Devices have to meet the regulations for OTC medical device labeling (21 C.F.R. 801.61, 21 C.F.R. 801.62 Read more about When, if ever, does labeling for Prescription Medical Devices need to meet OTC regulations?

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By Keller and Heckman LLP’s Packaging Practice Group

Prior to 1998, companies supplying the raw materials for medical devices were often Read more about Limiting Liability of Medical Device Materials Suppliers

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