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The labeling includes specific U.S. rates for acute pancreatitis, spontaneous hyperinflation, gastric and esophageal perforation and aspiration. Read More
Stakeholders recognized the need for the TGA “to take action to improve the current arrangements for custom-made medical device regulation, which are too broad,” the agency said. Read More
Not only was equipment found to be out of calibration at All Quality & Services’ Fremont, Calif. facility, but the contract device manufacturer failed to document remedial actions, CAPA activities or investigate complaints, a January to February FDA inspection found. Read More
A January inspection of Gallaway, Tennessee-based device manufacturer Medegen Medical Products by the FDA uncovered a range of quality system failures, including a serious lack of process controls for which the firm received a 13-item Form 483. Read More
The agency advised that complete test reports are not necessary for special 510(k)s or for tests which have been provided a declaration of conformity to an appropriate agency-recognized consensus standard. Read More