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FDA Updates Regulatory Affairs Newsletter Archive

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Importer Certification Statement Form Now Available

The CDC Import Permit Program (IPP) regulations provide that any noninfectious biological agent or biological substance that is being imported into the U.S. must be accompanied by an importer certification statement confirming that the material is not known to contain or suspected of containing an infectious biological agent or has been rendered noninfectious. See 42 CFR 71.54. To assist with…
Ben Kemp
September 25, 2024
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FDA Webinar 24th October – Total Product Life cycle oversight of IVDs

FDA is hosting a webinar on 24 October on its total product life cycle (TPLC) oversight of in vitro diagnostics (IVD). Stakeholder questions need to be submitted by email by 23 September.
Ben Kemp
September 11, 2024
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FDA Classification update

FDA have updated their classification codes for devices intended: To detect and identify nucleic acid targets including SARS-CoV-2 in respiratory specimens (Class II with special controls), To detect and identify selected microbial agents that cause acute febrile illness (Class II with special controls)
Ben Kemp
August 20, 2024
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 01 Jul)

Small Entity Compliance Guide: Laboratory Developed Tests The U.S. Food and Drug Administration (FDA) have issued a Small Entity Compliance Guide (SECG) to assist small entities in complying with FDA regulations as they apply to in vitro diagnostic (IVD) products, including laboratory developed tests (LDTs). The LDT final rule published on May 6, 2024, amends the FDA’s regulations to make…
admin
July 10, 2024
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 03 Jun)

Importing H5 Avian Influenza Samples On June 6, the Federal Select Agent Program announced a new H5 Avian Influenza Virus Exemption. The Administrator of the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) has utilized his exemption authority under 9 C.F.R. 121.5(f) in the select agent and toxin regulations to temporarily exempt H5 avian influenza viruses…
admin
June 12, 2024
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