TGA Pushes for Total Product Lifecycle Approach to Medical Device Cybersecurity

Australia – TGA Pushes for Total Product Lifecycle Approach to Medical Device Cybersecurity

New draft guidance from Australia’s Therapeutic Goods Administration (TGA) encouraged use of regulatory policies that span total product lifecycles (TPLC) to ensure medical device...
CDRH Drafts Guidance on Mouse Embryo Assays

USA – MDUFA Report Touts CDRH Efforts to Improve Medical Device Review Processes

Efforts at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) to improve the medical device review process under the Medical...
What Will 2019 Bring for Medtech?

USA – What Will 2019 Bring for Medtech?

Healthcare is definitely changing, evident from several developments in 2018. While payers and providers have been working for some time to improve healthcare quality...
Medical Device QMS Harmonization: US Considers Aligning to ISO 13485

USA – Medical Device QMS Harmonization: US Considers Aligning to ISO 13485

US FDA is considering adoption of ISO 13485:2016 quality system requirements for medical device registrants. ISO 13485 would replace FDA Quality System Regulations...
Essure Discontinuation Doesn't Mean the End to FDA Scrutiny

USA – Essure Discontinuation Doesn’t Mean the End to FDA Scrutiny

FDA wants the public to know it is taking steps to make sure the long-term safety profile of a controversial birth control device continues...
FDA Reclassifies Some ECT Devices

USA – FDA Reclassifies Some ECT Devices

Electroconvulsive therapy (ECT) devices used for the treatment of catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder...
Statement on the Investigational Use of Marketed Drugs in Clinical Trials

Canada – Health Canada Details Medical Device Action Plan

Health Canada issued a new action plan on Thursday, detailing a three-part strategy intended to improve safety, oversight and quality in the Canadian medical...
FDA Releases 20 Years of Data on Medical Device Adverse Event Reports

USA – US Regulatory Landscape for Medical Devices: A Year in Review and a...

From a transition to the global standard for quality management systems (QMS) to the revamping of premarket review pathways in the US, the medical...
US FDA Pushes 510(k) Performance Criteria, Predicate Device Policy Changes

USA – US FDA Finalizes Guidance on Breakthrough Medical Device Pathway

US FDA has published final guidance on its Breakthrough Medical Device market pathway for novel devices and combination products. The new program incorporates...
FDA previews safety-focused STeP pathway, finalizes breakthrough device guidance

USA – FDA previews safety-focused STeP pathway, finalizes breakthrough device guidance

The FDA today outlined its plans for finalizing guidance on its Breakthrough Device Program as well as plans for a new Safer Technologies Program...

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