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The Verifying Accurate Leading-edge IVCT Development (VALID) Act was included as part of user fee reauthorization legislation that passed through the Senate Committee on Health, Education, Labor and Pensions (HELP) Tuesday in a 13 to 9 vote. Read More
The FDA has just published the agency’s latest update to its Recognized Consensus Standard Database that device sponsors can cite in their device submissions. Read More
The EU’s Medical Device Coordination Group (MDCG) is warning device companies that they risk not being able to market their previously approved products in Europe if they are not in compliance by the time the transitional period for the Medical Device Regulation (MDR) ends on May 26, 2024. Read More
An early feasibility study is finding that hydrogel injected into lumbar spinal discs is safe while substantially relieving chronic low back pain caused by degenerative disc disease (DDD). Read More
FDA regulations in 21 CFR 820.70(g) lay out the three key areas that form the backbone of installation qualification (IQ) of manufacturing equipment. Read More
The FDA issued Stand Aid of Iowa a Form 483 that listed several deficiencies seen in previous inspections, including inadequate procedures for nonconforming products and for assigning serial numbers to finished devices. Read More
A user of SoClean’s device for cleaning continuous positive airway pressure (CPAP) devices is seeking a federal class action lawsuit against the company, claiming that the cleaning machine leaks toxic ozone gas. Read More