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Contract device manufacturer Valtronic netted a Form 483 for inadequate CAPA procedures, nonconforming products and a failure to document validations at its Solon, Ohio plant. Read More
In a March 19 webinar, the FDA amplified its commitment to exercising discretion when devicemakers seek waivers for new requirements that aim to support quality and… Read More
The FDA ordered a Beverly Hills plastic surgeon to stop marketing an implantable pouch that the doctor says can help prevent a nasty side effect for women’s breast augmentations. Read More
The Health and Human Services inspector general has green-lighted a sponsor’s request to offer smart phones to poor patients so they can take an antipsychotic drug with an electric sensor. Read More
AdvaMed called for Health Canada to revise and clarify its draft guidance on licensing requirements for implantable devices made through 3D printing. Read More
As the partial government shutdown entered a record-setting fourth week, the FDA expanded high-risk inspection activities by bringing back more unpaid staff. Read More
The FDA has reclassified electroconvulsive therapy (ECT) devices that treat catatonia or severe major depressive episodes or bipolar disorder as moderate risk devices with special controls. Read More
The FDA hit Monmouth Junction, New Jersey device manufacturer Replication Medical with a Form 483 following an inspection that revealed issues with the firm’s documentation of corrective and preventive action activities and device history records. Read More