Industry News
Remote Release and Remote Audits: New Answers from the EU
From ECA Academy The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed on a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing...
Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections
FDA has temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated...
FDA Emergency Use Authorization for in vitro diagnostics (COVID-19)
On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19....
Newly Revised ISO Standard Will Help Device Manufacturers Address Risk Management
(from RAPS, December 2019) The International Organization for Standardization (ISO) unveiled its revised standard on the application of risk management to medical devices, giving more attention to the benefits expected from devices, as well other clarifications and...
Audit Trail Reviews of Electronic Health Records
Are You Managing Your Electronic Health Records Properly? According to the ECA Academy, MHRA inspectors have recently noticed several major findings during their inspections. Issues have been noted with audit trails, access and security, scanning and certified...
Audit Trail Reviews of Electronic Health Records
Are You Managing Your Electronic Health Records Properly? According to the ECA Academy, MHRA inspectors have recently noticed several major findings during their inspections. Issues have been noted with audit trails, access and security, scanning and certified...
Premarket Submissions for Non-Clinical Bench Performance Testing
Do you know the content and format requirements for submitting Premarket Submissions for Non-Clinical Bench Performance Testing? Recent FDA guidance describes the relevant information that should be included in test report summaries, test protocols and complete test...
Quality Requirements for Drug-Device Combinations
(From European Medicines Agency): Guidance is provided on dossier requirements for drug-device combinations (DDCs) in the context of a regulatory submission (marketing authorisation application and post-authorisation application). The types of DDCs within the scope of...
FDA: Initiation of Voluntary Recalls
From the Federal Register, Wednesday, April 24, 2019: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.’’ The draft...
InDevR Gains Market Clearance for Influenza A+B Assay
(From FDA Device News) The FDA granted InDevR 510(k) clearance for its FluChip-8G influenza diagnostic test, an assay that can identify multiple non-seasonal viruses. The in vitro diagnostic test qualitatively detects and distinguishes between several influenza A...