US Regulatory Landscape for Medical Devices: A Year in Review and a Look Ahead

USA – CDRH Touts Uptick in Foreign Device Inspections

The US Food and Drug Administration (FDA) saw a 243% spike in the annual number of foreign medical device inspections conducted by agency officials...
FDA isn't doing enough to prevent medical device hacking, HHS report says

USA – FDA isn’t doing enough to prevent medical device hacking, HHS report says

The US Food and Drug Administration is not doing enough to prevent medical devices such as pacemakers and insulin pumps from being hacked, a report...
FDA to beef up cell and gene therapy staff

USA – US FDA’s Medical Device Division Lays Out Regulatory Guidance Plans for 2019

EMERGO SUMMARY OF KEY POINTS: US FDA’s medical device oversight division identifies key guidance publication plans for 2019. Top FDA Center for Devices and...
Considering Old and New 510(k) Predicates

USA – Considering Old and New 510(k) Predicates

The 510(k) route to market for Class II devices involves the comparison of the candidate device to a legally marketable (already cleared) device. Note...
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 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...
EU Releases Working Plan to Implement MDR/IVDR

Europe – EU Releases Working Plan to Implement MDR/IVDR

The European Commission (EC) issued a working plan on Wednesday for the implementation of the new EU medical device and in vitro diagnostics regulations...
Does More FDA Oversight Equal Better Compliance?

USA – Does More FDA Oversight Equal Better Compliance?

Since 2007, FDA has increased its annual number of medical device inspections by 46% and has increased annual inspections of foreign firms by 243%....
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...
Biosimilars Forum Calls for FDA Guidance to Address Misinformation

USA – CDRH Issues Final Orders on Medical Devices for Insulin Adjustment, Drug Screening

The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) issued two final orders on Wednesday, classifying the...

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