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Post-Market Device Safety
In 2006, the FDA announced a post-market surveillance effort, “ensuring the safety of marketed medical devices: CDRH’s Medical Device Post-Market Safety Program.” This effort was out of concern that medical device adverse event data is inadequate. This FDA CDRH Post-Market initiative is driven by risk. CDRH will rely on a broad range of data sources including voluntary and mandated reporting, inspections, and non-traditional data from the public sector.
During an FDA media teleconference on Sept. 27, 2007 regarding the FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 (FDAAA2007) a FDA spokesperson stated “that this bill and its provisions are very consistent with what has been our FDA philosophy of being engaged in the total life cycle of these products to ensure their quality on the front end as they come in, in the pre-application process and to continue to stay engaged as they are now being utilized in larger populations that we continue to learn from that experience.”
There are changing concepts of non-routine risks, with implications for maintaining a device’s approval status in the face of newly available benefit/risk data. Further complicating the picture is the emerging role of Centers for Medicare and Medicaid Services (CMS) in sponsoring outcomes research, and even conditioning Medicare payment for treatment on paying for (in the case of drug/device sponsors) and participating in (in the case of patients) efficacy/outcome studies.
What is your plan? Now is the time to expand your post-marketing surveillance strategy to include data collection to accurately monitor the safety and effectiveness of marketed medical devices. WATERMARK supports those efforts through post-marketing safety surveillance for safety oversight and patient outcome registries for collecting information on a product uses and effectiveness.
Click here to be directed to information on post-market safety surveillance.
Click here to be directed to patient outcome registry information
Click here to download the FDA document “Ensuring the Safety of Marketed Medical Devices CDRH’s Medical Device Postmarket Safety Program”.
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