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In a case that involves two medical device companies, the Federal Circuit Court of Appeals has ruled that the method for appointing Patent Trial and Appeal Board’s… Read More
An FDA inspection of Highland Industries’ Cheraw, South Carolina facility uncovered numerous quality system deficiencies including missing validation and manufacturing records and test reports, along with a slew of other documentation failures. Read More
Failure to validate design under defining conditions, poor documentation and failure to evaluate complaints were a few of the deficiencies observed during an FDA inspection of surgical lighting manufacturer Sunnex’s Charlotte, North Carolina facility. Read More
The FDA has categorized an internal therapeutic massager and an orthopedic surgical instrument used for osteochondral implants as Class II devices, assigning them special controls. Read More
The FDA offers new advice for devicemakers on 510(k) submissions for guidewires used in coronary, peripheral and neurovasculature in a final guidance released last week. Read More
A new final guidance from the FDA allows some sponsors of oncology products to file a single application for use of an investigational diagnostic in their trial rather than filing for the drug and device components separately. Read More
Failure to establish procedures for design changes and for acceptance of incoming product, were among the quality management lapses uncovered during a May 13-16 FDA inspection of Vasamed’s Eden Prairie, Minnesota plant. Read More
Management at Hospital Therapy Products failed to establish a quality plan, quality audits, or procedures for management reviews, a May 7-14 inspection of the firm’s Wood Dale, Illinois inspection revealed. Read More
In a newly released guidance, the FDA spells out what manufacturers need to consider when labeling catheters, wires and delivery systems with lubricious coatings used during minimally invasive diagnostic and therapeutic vascular procedures. Read More
The FDA has set out a framework how devicemakers will be able to demonstrate products are as safe and effective as a predicate device under an expansion of the agency’s abbreviated 510(k) pathway for certain, well understood device types. Read More