OIVD Mission

We work to promote and protect public health through clear and consistent regulation of in vitro diagnostic devices (IVDs). We have a dual charge to foster the rapid transfer of good new IVDs into the medical market while preventing marketing of unsafe or ineffective devices. We strive to ensure our work is transparent and allows all stakeholders to obtain the knowledge required to make informed decisions about the development, production, and use of IVDs.

OIVD provides timely, comprehensive, and integrated regulatory oversight for IVDs through our Total Product Life Cycle program by:

• applying technical and administrative expertise seamlessly to a continuum of regulatory processes;
• encouraging systematic information flow and feedback between the CDRH offices and divisions involved in the regulation of IVDs and using this feedback to improve oversight of the devices before and after they reach the market;
• maximizing the timeliness of decision-making and staff interaction;
• actualizing the spirit of the least burdensome provisions of FDA Modernization Act (FDAMA) by expanding the choices available and simplifying the current methods for defining IVD performance; and
• developing new methods of postmarket monitoring of IVDs that produce a more complete picture of IVD device behavior in an everyday setting.