USA – FDA’s CDRH releases list of proposed guidances for FY 2024
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has named the guidance documents it plans to publish during Fiscal...
USA – Best Practices for Selecting a Predicate Device to Support a Premarket Notification...
FDA developed this document to provide guidance to industry and FDA staff about best practices in selecting a predicate device for premarket notification ...
USA – Convergence: Tips for when to include PCCPs in product submissions
The US Food and Drug Administration (FDA) sees predetermined change control plans (PCCPs) as a way to improve medical device innovation in the country,...
USA – FDA guidances keep coming, new device harmonization plan, and more
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical...
USA – FDA official discusses use cases, limits for device PCCPs
While predetermined change control plans (PCCPs) may not typically be appropriate for changes to a device’s indications for use, they can be useful for...
USA – FDA official warns device makers over supply chain risks
Manufacturers and healthcare providers are reverting to old business practices that could jeopardize medical device supply chains in the event of another public health...
USA – US FDA sets some steep increases for 2023 medical device user fees
The US Food and Drug Administration announced that it has set medical device user fees for fiscal year 2023. Medical device manufacturers and importers seeking...
International – FDA warns Philips about imaging device violations at China facility
The US Food and Drug Administration (FDA) has warned Philips about manufacturing violations at the company’s facility in Suzhou, China, where computed tomography (CT)...
USA – FDA finalizes guidance for containment system used with power morcellators
The US Food and Drug Administration (FDA) has finalized guidance that lists non-clinical testing information the agency wants from sponsors of tissue containment systems...
Europe – Votre avis sur l’extension de la période de transition des RDM et...
La Commission européenne va soumettre au Parlement européen et au Conseil une proposition d'amendement modifiant les règlements (UE) 2017/745 (RDM) et (UE) 2017/746 (RDMDIV) en ce...
