OIVD Expertise
OIVD consists of a multidisciplinary group of scientists and other
professionals including medical technologists, research scientists,
policy analysts, industry scientists, scientists with field FDA
experience, engineers, pathologists, and clinicians who are collectively
dedicated to promoting and protecting public health. Our unique
and diverse expertise enhances the effectiveness and impact of CDRH
programs. We apply IVD expertise across all premarket and postmarket
activities by combining the premarket evaluation component with
the compliance/enforcement component within CDRH. The result is
a multi-disciplinary and cross-linked organization which fosters
efficient cradle-to-grave oversight of IVDs grounded in good science.
We specialize in:
- consolidating all regulatory activities for IVDs,
- improving the acquisition and dissemination of knowledge about
IVDs,
- enhancing industry and professional group networking, and
- focusing and refining IVD regulation.
History of the Regulation of IVDs
The following table highlights key dates in the history of IVD
regulation.
Date |
Regulatory History |
| December
1969 |
The
Supreme Court ruled that antibiotic-containing discs were subject
to certification by FDA as a drug. |
| January
1972 |
FDA's
Bureau of Drugs established a Diagnostic Products Staff. |
| August
17, 1972 |
Final
labeling requirements for in-vitro diagnostic products were
published. |
| March
15, 1973 |
The
Federal Register published new FDA regulations about labeling
requirements and procedures for development of standards for
IVD products for human use. |
| February
15, 1974 |
The
Bureau of Medical Devices and Diagnostic Products was established. |
| May
28, 1976 |
The
Medical Device Amendments to the Food,
Drug, and Cosmetic Act:
- established risk-based
classification for all medical devices,
- provided a set of general
controls for all medical devices,
- included "in vitro
reagent" in the definition of a device.
|
| May
24, 1977 |
The
Bureau of Medical Devices and Diagnostic Products was
renamed the Bureau of Medical Devices (BMD).Within
the Office of Device Evaluation of BMD was the Division
of Clinical Laboratory Devices. |
| April
1, 1982 |
A
memorandum of understanding took effect, under which the Bureau
of Medical Devices transferred to the Bureau of Biologics the
responsibility (under the Medical Device Amendments
of 1976) for regulating devices that were also licensed biological
products or used in their production (21 CFR 864, Subpart J
of the hematology regulations). |
| October
10, 1982 |
The
Bureau of Radiological Health and Bureau of Medical Devices
merged to become the National Center for Devices And
Radiological Health. |
| March
19, 1984 |
The
National Center for
Devices and Radiological Health was renamed
the Center for Devices and Radiological Health. |
| 1990 |
The
Safe Medical Devices Act
- provided Postmarket Surveillance
- provided Device Tracking
- required User Facility
Reporting
|
1992 |
The
Medical Device Amendments of 1992 established a single reporting
standard for user facilities, manufacturers and distributors |
November
21, 1997 |
The
FDA Modernization Act:
- reallocated resources to
focus on medical devices that present the greatest risks
to patients,
- added the Least Burdensome
Provisions to the Food, Drug, and Cosmetic Act.
|
October
26, 2002 |
The
Medical Device User Fee and Modernization
Act:
- established user fees for
premarket reviews,
- permitted establishment
inspections by accredited third-parties,
- presented new regulatory
requirements for reprocessed single-use devices.
|
| November
17, 2002 |
The
Office of In Vitro Diagnostic Device Evaluation and Safety formed
in order to consolidate all regulatory activities for IVDs. |
|
