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Stanmore Implants Worldwide, a manufacturer of extendable femur and knee-replacement devices, received an FDA warning letter for corrective and preventive action, complaint handling and auditing violations. Read More
A contact lens manufacturer that failed to respond to a Form 483 in February following an FDA inspection now must respond to a warning letter. Read More
Devicemakers up for routine postmarket surveillance audits in Malaysia will get at least two weeks’ notice, the country’s Medical Device Authority says. Read More
The Indian government is developing a medical device postmarket surveillance system, following a series of high-profile incidents in which faulty products harmed patients. Read More
The FDA handed Encompas Unlimited a warning letter for failures in quality control, implementation of medical device reporting procedures and incomplete device history records.
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Devicemakers can improve their facility inspection experience by engaging in constructive conversations with agency investigators, an FDA official says. Read More
Swiss and Chinese regulators plan to harmonize their regulations on market authorization and postmarket surveillance, with the aim of speeding access to new products in both markets. Read More
The FDA has warned Craftmatic Industries over inadequate complaint handling and manufacturing procedures for its Adjustable Home-Use Therapeutic Bed. Read More