(IVDD for EU supplied by mdi Europa) elow is a short summary of the most important changes that are coming our way with the new IVDR. Some of these have been discussed before in our newsletters and / or mailings, however, the below article gives another complete overview: Liability: Insurance coverage for manufacturers will be
As per, Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007, “If the course of the disease or condition and the effects of the device are sufficiently similar in adults and pediatric patients, the Secretary may conclude that adult data may be used to support a determination of a reasonable assurance of effectiveness in
FDA Draft guidance for your comments Medical devices are used by people of not only different geographic variables but also demographic variable like Age, Sex, Race and Ethnicity. The primary intent of this draft guidance us to improve the quality, consistency and transparency of data regarding the performance of medical devices within specific age, race,
Draft Guidance for your comments This draft guidance document provides clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. FDA believes that explaining the factors listed in this draft guidance document will improve
This FDA draft guidance provides recommendations to industry, healthcare providers, and FDA staff about the mechanisms and considerations for device manufacturers to facilitate the appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers and sharing such information with patients when they request it. FDA believes that
FSMA Final Rule for Mitigation Strategies to Protect Food against Intentional Adulteration!! The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Rather than targeting specific foods or hazards, this rule requires
As a part to protect the people from various illnesses resulting from food contamination during transportation because of unsanitary transportation practices, FDA issued a final rule on Sanitary Transportation of human and animal food. The Final rule is the sixth major rule under the Food Safety Modernization Act (FSMA). The rule strengthens the Sanitary Food
Since the issuance of 2013 revised FDA Guidance “Cosmetic Good Manufacturing (GMP) Guidelines/Inspection Checklist”, FDA enforcement of cosmetic manufactures has been steadily on the rise. FDA has always used warning letters as an effective compliance mechanism to let companies know that they have violated the laws and to tell them what corrective action they need
FDA Issues Warning Letters for making drug claims on Cosmetic Products FDA has always used warning letters as an effective compliance mechanism to let companies know that they have violated the laws and to tell them what corrective action they need to take. Over the years, FDA has issued a number of warning letters directed
The Successful implementation of FSMA can be achieved by a new level of cooperation and collaboration between the Federal, States, and Regional regulatory and food safety entities. The announcement of $19 million funding in FY 2016 is an important step by FDA to provide the necessary resources to the state to advance efforts for a
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