Appendix A – FY 2005 OIVD Annual Report - Summary of Major CDRH Programs

OIVD is responsible for the program areas where in vitro diagnostic devices are regulated from conception to obsolescence. This Appendix provides summary information on major program areas administered by parallel offices (ODE, OC, and OSB). OIVD is responsible for carrying out its activities in a consistent manner with all of these programs area. Please see below for a summary of the OC and OSB program areas; and refer to the ODE Annual Report, Appendix A, for a brief description of the premarket programs.

Office of Compliance (OC)

The Enforcement / Compliance program stimulates awareness within the agency of the need for prompt and positive action to ensure compliance by regulated industries; works to ensure an effective and uniform balance between regulatory compliance and agency responsiveness to consumer needs; acts as liaison with other federal agencies on agency compliance matters, and encourages an effective and appropriate balance between voluntary and regulatory compliance; evaluates and coordinates proposed legal actions to ascertain compliance with regulatory policy and enforcement objectives; evaluates and coordinates proposed legal actions to ascertain compliance with regulatory policy and enforcement objectives.

Office of Surveillance and Biometrics (OSB)

The Food and Drug Administration Modernization Act of 1997 (FDAMA) modified Postmarket Surveillance (PS) requirements under section 522 of the Act. Postmarket surveillance means the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. The data can reveal unforeseen adverse events, the actual rate of anticipated adverse events, or other information necessary to protect the public health.

Postmarket issues may be identified through a variety of sources, including analysis of adverse event reports, a recall or corrective action, warning letter, a seizure, reports from other governmental authorities, or the scientific literature. The guidance document “Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act” can be viewed at: http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm072517.htm

Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. On July 31, 1996, the new Medical Device Reporting (MDR) regulation became effective for user facilities and device manufacturers.
The Medical Product Safety Network (MedSun) is a pilot program launched in 2002 by CDRH. The primary goals for MedSun are to identify, understand and share information about problems with the use of medical devices. MedSun plays an important role in FDA's post-market surveillance effort. Hospitals, nursing homes, and other healthcare facilities are currently required to report medical device problems under the Safe Medical Devices Act (SMDA). MedSun provides a secure, Internet-based data entry system that automates this process and helps gather other additional data that can help FDA, device manufacturers, and clinical facilities proactively address safety concerns before serious injuries or deaths occur.