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Combination product agreement meetings — known within the FDA as CPAMs — are a prime way sponsors of such products can gather agency feedback on their applications, the agency said in a final guidance released yesterday. Read More
The FDA issued final guidance for bioburden reduction systems that use dry heat to help support single-user reuse of certain particulate filtering facepiece respirators (FFRs) as the need for FFRs may outpace the supply available to healthcare organizations during the COVID-19 pandemic. Read More
Australia’s Therapeutic Goods Administration (TGA) released new regulatory requirements for personalized medical devices that will go into effect on Feb. 25, 2021. Read More
The European Commission’s Medical Device Coordination Group has released long-awaited guidance on how to classify products for compliance with the European Union’s In Vitro Diagnostic Regulation (EU IVDR). Read More
When asking for a meeting, sponsors should include product information, such as a description of the product and its constituent parts, the agency said. Read More
The guidance says the annual survey ideally should be completed as soon as possible, occurring within six months of the 14-month date from the prior completed survey. Read More
Specifically, the agency is allowing certain dry heat systems to be used on authorized FFRs that do not have exhalation valves, do not use a duck-bill design and do not contain antimicrobial or antiviral agents. Read More
The new regulation goes into effect on May 26, 2022, except for in vitro diagnostics that qualify for a grace implementation period that extends to May 27, 2024. Read More
“Of serious concern is the fact that around 18 months away from IVDR date of application, the specific Class D conformity assessment infrastructure is limited or missing altogether,” MedTech Europe said. Read More
A draft FDA guidance recommends sponsors of medical devices that are electrically powered or have electronic circuitry provide 11 categories of safety information in their premarket submissions. Read More
As part of its vast overhaul of its drugs and devices regulatory system, China has been placing a heavy emphasis on postmarket surveillance over the last two years. Read More