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A “Dear Colleague” letter signed by 39 House members pledged their support for a 2.79 percent inflationary increase for the FDA’s Center for Devices and Radiological Health (CDRH) in President Bush’s 2006 budget.
Medical device firms need to understand their rights if they want to efficiently survive an FDA inspection, an expert on regulatory compliance issues told attendees at a device quality conference in San Diego last week.
The FDA’s Office of Device Evaluation (ODE) completed the processing of 8,573 submissions in fiscal 2004, including 3,376 510(k) applications, according to the office’s annual report, which was released March 10.
The FDA has extended a pilot program for evaluating globally harmonized medical device premarket applications (premarket notifications, or 510(k)s, and premarket approval applications, or PMAs), accepting submissions in this format until July 2006.
As part of the FDA’s $1.9 billion budget proposed for fiscal 2006, the agency asked for an almost $6 million increase for the Medical Device and Radiological Health Program to take the requested budget total to approximately $221 million.
HHS has decided not to recommend substantive policy, administrative or legislative changes related to barriers to the availability of pediatric medical devices, but instead will propose conducting a needs assessment to “determine the scope of unmet device needs in the pediatric population,” according to a recently released report.
Epilepsy devicemaker Cyberonics has submitted a response to the FDA saying that the company “is committed to working with the Dallas district office” to resolve nonconformities with current good manufacturing practices (cGMPs) found during an inspection of its Houston facilities.
Manufacturers of self-expanding and balloon-expandable extracranial intravascular stents should submit their nonclinical test protocols to the FDA before conducting any tests, the agency recommended in a recently released guidance document.
The FDA’s Center for Devices and Radiological Health released a question-and-answer guidance document intended to clarify how 21 CFR Part 820 of the quality system (QS) regulation applies to software maintenance activities for networked medical devices.
Houston-based Cyberonics has acknowledged the receipt of a warning letter from the FDA saying the company’s responses to issues involving current good manufacturing practices (cGMPs) at one of its manufacturing facilities were insufficient.