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If sequestration cuts continue into the 2014 fiscal year, CDRH will not be able to hire the review staff the agency promised to hire under MDUFA III, Director Jeffrey Shuren told Congress Friday. Read More
Seattle-based Atossa Genetics has initiated a Class I recall of all lots of its Mammary Aspiration Specimen Cytology Test (MASCT) and the accompanying patient sample kit, along with the ForeCYTE Breast Health Test Kit, manufactured between Jan. 9 and Sept. 13, 2013. Read More
A group of patient advocacy organizations is urging Congress to pull back on proposed cuts in Medicare coverage for medical imaging, saying further reductions will seriously impede access to life-saving screening and radiation therapy services. Read More
California start-up Scanadu expects to begin clinical trials of its Scanadu Scout medical tricorder in early 2014, after securing $10.5 million in Series A financing from Relay Ventures, VegasTechFund and Ame Cloud Ventures. Read More
Better communication between CDRH and the Center for Drug Evaluation and Research should translate to fewer requests for duplicate data on companion diagnostic submissions. Read More
A Thursday draft guidance from CDRH attempts to clarify the distinction between hearing aids and personal sound amplification products, or PSAPs. Read More
CDRH plans to roll out 12 final guidance documents in fiscal 2014, including guidances on cybersecurity, the device appeals process and the global unique device identification database, or GUDID, the center revealed Thursday. Read More
The International Medical Device Regulators Forum will launch its medical device single audit program (MDSAP) pilot in January in the U.S., Canada, Australia and Brazil. Read More
FDA investigators increasingly are shifting from “top down” inspections focused on policies to “bottom up” inspections that focus on raw data, an industry insider says. Read More
Revisions to the FDA’s Regulatory Procedures Manual don’t add any clarity on when a product removal is a recall and when it’s a market withdrawal, attorneys say. Read More