The FDA hit three device facilities with 483s for quality violations observed during agency inspections. Source: The GMP Letter

The FDA sent warning letters to six device companies for violations including missing documents, design validations, and other compliance lapses. Source: The GMP Letter

Former FDA Chief Scientist Jesse Goodman told a House subcommittee hearing that the FDA’s decision to allow diagnostic test developers to self-validate their COVID-19 products caused a flood of unqualified…

The FDA announced that it will delay enforcement of new requirements for unique device identification (UDI) on class I and unclassified medical devices until Sept. 24, 2022. Source: The GMP…

The FDA has released a new Emergency Use Authorization (EUA) template to help devicemakers develop COVID-19 tests for at-home self-collection. Source: The GMP Letter

The European Commission’s Medical Device Coordination Group (MDCG) outlined in a new guidance how devicemakers should report safety incidents for clinical studies under the new Medical Device Regulation. Source: The…

Failure to document corrective and preventive action (CAPA) activities related to its x-ray equipment landed Deerfied Imaging a Form 483 from the FDA following an inspection of its Minnetonka, Minnesota…

Inadequate procedures for managing corrective and preventive actions and for monitoring and controlling process parameters landed DJ Orthopedics a form 483 following an FDA inspection of its Tijuana, Mexico facility.…

Perahealth didn’t have any design plans for its PeraTrend and PeraServer software used in monitoring patients, and it lacked appropriate documentation for numerous quality system processes, according to a Form…

Failure to file medical device reports with the FDA within the prescribed 30-day period after becoming aware that its glucose meter may have contributed to an injury landed South Korea’s…