US FDA Cybersecurity Alert: Risks Found in Medical Device Software Components
The FDA reports cybersecurity threats found in some software components require medical device makers to take prompt action.
US FDA Issues Quality Management System Amendment FAQs
US FDA has provided answers to Frequently Asked Questions regarding planned harmonization of 21 CFR Part 820 quality management system requirements with the ISO 13485 standard.
How Long is the FDA Review Process for 510(k) Medical Device Submissions?
US FDA provides communication timeline for 510(k) reviews in accordance with MDUFA III performance goals.
US FDA Formally Proposes Aligning Quality System Regulations with ISO 13485
Proposed rule from US Food and Drug Administration harmonizes 21 CF Part 820 to ISO 13485 quality management system standard for medical devices.
US FDA Roundup: Final Rules for Combination Products, Patient Reports for Medical Device Evaluation
Medical device manufacturers and sponsors, learn more at Emergo by UL about FDA rules on combination products; patient input on medical device evaluations and clinical studies so you can get to market approval faster.
US FDA Rolls Out Notification Requirements to Protect Medical Device Supply Chains
New US FDA guidance on notifications of medical device discontinuation or supply disruption during public health emergencies.
COVID-19 Pauses US FDA Inspection Plans, Again
The Food and Drug Administration has extended its remote inspection policy for pharmaceutical, medical device and other healthcare product manufacturers as the COVID-19 public health emergency persists.
Japan PMDA Updates MDSAP Policies Ahead of 2022 Implementation Deadlines
Japanese regulators prepare for full acceptance of MDSAP audit reports for medical device quality management system (QMS) conformity assessments in 2022.
EU Regulatory Roundup: Combination Products, Eudamed, COVID-19 IVDs
Latest guidelines from European Medicines Agency (EMA) and EC Medical Device Coordination Group (MDCG) on CIV-ID generation for clinical studies, COVID-19 IVD performance evaluations and more.
US FDA Medical Device User Fees See Modest Increase for 2022
FDA has set a 2.5% increase for medical device user fees for its 2022 fiscal year. Learn more about US medical device and IVD regulations at Emergo by UL.