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The US FDA has announced that manufacturers of new COVID-19 tests should now follow traditional premarket pathways.
The US FDA announced that it has launched a pilot program designed to help medical device premarket reviews become more efficient.
The UK’s MHRA invited public comment regarding its proposed fee increases.
The US FDA released a list of guidances it plans to issue over its 2023 fiscal year.
A use-related risk analysis (URRA) is an important cornerstone activity in your human factors engineering (HFE) process that is expected by regulators.
A survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification under the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR).
Health Canada finalized guidance on clinical evidence requirements for medical devices.
Health Canada reminded manufacturers of EHR-based medical devices to obtain a medical device license and/or establishment license.
Malaysia’s MDA published draft guidance that provides a notification process for manufacturers of custom-made medical products when seeking Malaysian market access.
The US FDA has issued draft guidance on select updates for the Breakthrough Devices Program guidance, expanding its scope to devices that will improve accessibility.
The FDA released its 2023 medical device user fees and some have increased sharply since last year.
Taiwan’s MOHW has issued a draft revision of UDI requirements and a draft amendment of the charge standards of administrative fees for medical devices.
The US FDA has revised its guidance document to update the considerations on identifying and responding to deficiencies in premarket submissions.
New laws will enable manufacturers to leverage their FDA registrations for Swiss market access
Electronic indications for use (IFUs) becoming more common for medical products and devices
US FDA issued revised guidance on definitions of device and counterfeit device. FDA also issued a revised MedWatch Form 3500A for adverse event reporting
New and upgraded learning management and training features to support pharmaceutical, medical device and biotechnology companies
New provisions cover products with no intended medical purpose
Updates include changes to ANVISA classification rules for software as a medical device (SaMD), technical dossier rules and more
New European MDCG paper lays out actions to increase Notified Body capacity, avoid medical device and IVD shortages
