FDA to Exempt Unclassified Devices From Premarket Notification
The FDA is planning to exempt certain unclassified devices from premarket notification requirements, according to an updated guidance from the agency. Source: The GMP Letter
Sarstedt Called Out for Inadequate Documentation
The FDA rapped Newton, North Carolina devicemaker Sarstedt after a June 28 to July 2, 2018 inspection revealed deficiencies in its document change and labeling procedures. Source: The GMP Letter
TGA Proposes Overhaul for SaMD, Personalized Devices
Australia’s Therapeutic Goods Administration issued two new guidances, one proposing a regulatory framework for personalized medical devices and the other on regulation of software, including software as a medical device…
Imaging Biometrics Cited for Complaint Investigation Records
The FDA hit Imaging Biometrics with a Form 483, calling the Elm Grove, Wisconsin healthcare software developer out for its medical device reporting procedure and complaint records. Source: The GMP…
Massachusetts Devicemaker Hit for Discrepancy Investigation Reports
The FDA cited Acorda Therapeutics’ Chelsea, Massachusetts manufacturing facility for its handling of discrepancy investigations observed during a June 4-18, 2018 inspection. Source: The GMP Letter
FDA Warns Total Thermal Imaging for Unapproved Screening Device
The FDA warned La Mesa, California-based devicemaker Total Thermal Imaging for marketing an unapproved device for breast cancer screening. Source: The GMP Letter
TGA Issues Draft Guidance on Regulations for Personalized Devices
Australia’s Therapeutic Goods Administration is seeking feedback from devicemakers on how personalized devices should be regulated. Source: The GMP Letter
McKesson Draws FDA’s First DSCSA-Related Warning Letter
The FDA issued its first warning letter under the Drug Supply Chain Security Act (DSCSA), hitting McKesson for violating verification requirements and allegedly shipping illegitimate product. Source: Drug GMP Report
FDA Warns 17 Companies Over Unapproved Alzheimer’s Drugs
FDA Commissioner Scott Gottlieb announced agency action against 17 companies for selling unapproved Alzheimer’s treatments. Source: Drug GMP Report
Stakeholders Call on FDA to Clarify Supply Chain Verification Guidance
Drugmaker and pharmacist groups called on the FDA to amend its draft guidance on supply chain verification systems, saying the draft doesn’t account for the varying conditions at facilities. Source:…
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