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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
The Centers for Medicare & Medicaid Services should be more transparent about its plans for the Sept. 30 first release of Physician Payment Sunshine Act data, device and biotech groups say. Read More
Multiple device units manufactured for a single patient usually won’t need to be tallied separately under the FDA’s five-unit limit on custom devices, a new final guidance clarifies.
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Whistleblowers who alleged CDRH read their personal emails cannot proceed with litigation at this time, according to a judge who said plaintiffs must first exhaust all administrative remedies to their claims. Read More
Manufacturers implementing unique device identification may choose a barcode for their Automatic Identification Data Capture technology, or they can use “any other technology that serves the same objectives,” new FDA guidance clarifies. Read More
Devicemakers are urging the Therapeutic Goods Administration to amend its low-value turnover exemption scheme for entries in the Australian Register of Therapeutic Goods to allow more small businesses to take advantage of it. Read More