Chemical Characterization of Medical Devices

CHEMICAL CHARACTERIZATION OF MEDICAL DEVICE (EN ISO 10993-18)     Chemical characterization is a crucial step in evaluating the biocompatibility of a medical device. It is done to identify and characterize the chemical constituents (extractables and leachable) which could disclose biological risk to patients and medical practitioners. Extractables are substances that can be released from…

Medical Device Labelling

  MDR LABELLING REQUIREMENTS     [A]   NON-ACTIVE MEDICAL DEVICES   Information on the Label Name or trade name of the device. Necessary details for a user to identify the device, the contents of the packaging and the intended purpose of the device. The name, registered trade name or registered trademark and the address of its…

506J Notification

What is FDA’s Section 506J Notification Section 506J notification of the FD&C Act requires manufacturers to notify the Secretary of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices. Which leads disruption in supply of that device in the United States. This policy is intended to…