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The FDA’s authority to reconsider and rescind earlier classification decisions could be severely limited following a recent federal court ruling. Read More
The FDA took another step toward assuming responsibility for the regulation of laboratory-developed tests with Friday’s publication of separate draft guidances on a proposed regulatory framework and medical device reporting requirements. Read More
The Department of Commerce has published its long-awaited compilation of all known conflict mineral processing facilities worldwide. But the department admits it lacks the ability to identify which facilities use minerals that finance conflict. Read More
As notified bodies in the EU conduct the first wave of unannounced quality audits of devicemakers, they are building profiles of the companies to determine when and how often they are inspected in the future. Read More
With FDA investigators soon to begin scrutinizing UDI compliance, Class III devicemakers should prepare by ensuring that UDI changes in design history files are adequately documented and that the company has a verification process for barcodes in place. Read More
The FDA plans to implement unique device identification requirements over several years, but fully expects and intends to be flexible during that time, an agency source says. Read More
Devicemakers will have 13 new product-specific guides by the end of the year to tell them what quality-related metrics FDA investigators will focus on during site inspections, agency officials said. Read More
A high-profile report calling for the elimination of the 510(k) system is misplaced, says Jeffrey Shapiro, director of the law firm Hyman, Phelps & McNamara, who argues what actually is needed is greater transparency. Read More