| 2001 |
| Closing
the square (IVDT) |
| Just
in time for the genetic product revolution, Bernard Statland brings a lifetime
of IVD experience to FDA's Office of Device Evaluation. |
| Waived-complexity
guidance enters comment period (IVDT) |
| When
it comes to the simplest of IVD tests, it seems, nothing is simple. |
| |
| 2000 |
| DCLD
restructuring (IVDT) |
| The
Division of Clinical Laboratory Devices (DCLD) at FDA's Center for Devices
and Radiological Health may soon undergo a change in its structure. Under
the terms of a proposed reorganization plan, the number of DCLD branches
responsible for reviewing product submissions would increase from three
to six. |
| FDA
genetic testing panel created (IVDT) |
| FDA's
Center for Devices and Radiological Health (CDRH) has recently named the
members of a new medical advisory committee created for genetic diagnostics. |
| |
| 1999 |
| FDA
to offer one-stop regulatory shopping (IVDT) |
| The
transition has been years in the making, but on January 31, 2000, FDA will
finally begin making complexity categorization determinations under the
Clinical Laboratory Improvement Amendments of 1988 (CLIA). |
| Glucowatch
on the fast track for FDA approval (IVDT) |
| After
completing a final series of clinical trials, Cygnus Inc. (Redwood City,
CA) has submitted to FDA the second and final module of the premarket approval
(PMA) application for its Glucowatch automatic glucose monitor. |
| FDA
labeling guidance gets mixed reviews (IVDT) |
| FDA's
draft document, Guidance on Labeling for Laboratory Tests, has elicited
a variety of reactions from industry, both good and bad, according to Carolyn
Jones, director of in vitro diagnostics and biomedical technical programs
at the Health Industry Manufacturers Association. |
| |
| 1998 |
| Genetic
diagnostics top FDA technology hit list (IVDT) |
| According
to a panel of experts surveyed by FDA's Center for Devices and Radiological
Health (CDRH), genetic diagnostics will be the most important new medical
device technology to be developed over the next decade. |
| Lifestream
files for handheld cholesterol monitor (IVDT) |
| The
growing number of people who are watching their serum cholesterol may someday
be able to monitor their levels at home. Lifestream Technologies, Inc. (Sandpoint,
ID), recently filed an FDA submission for approval of its handheld cholesterol
monitor, the Cholestron. |
| FDA
joint panel weighs uses of gold standards (IVDT) |
| Gene
amplification technologies are beginning to challenge the traditional paradigm
of culture as the gold standard for the diagnosis of infectious diseases.
But shifting paradigms isn't an easy matter. |
| |
| 1997 |
| FDA
advisory notices (IVDT) |
| In
July, 1997, FDA's Center for Devices and Radiological Health (CDRH) issued
two public health advisories relating to the use of diagnostics for toxoplasmosis
and Lyme disease. Both advisories resulted from recommendations of the device
center's microbiology devices advisory panel. |
| FDA
eyes adverse events for glucose monitors (IVDT) |
| How
many adverse events does it take for glucose monitors to land in hot water?
Not even FDA knows for sure. |
| Commentary:
Ethics of IVD use are outside FDA jurisdiction (IVDT) |
| In
her editor's page, Jenevieve Blair Polin quotes the checklist question "Does
the population at risk want the test?" as an influential factor in
determining whether a test should be developed. Meanwhile, the commentary
by FDA's Joseph L. Hackett, PhD, states that "the intended use should
offer some value to the user and the clinician." The major difference
between these perspectives lies in their understanding of who the users
of IVDs are. |
| CDC,
FDA, and manufacturers work together to improve identification of group
O HIV (IVDT) |
| Manufacturers
of HIV-1 tests and federal scientists are working earnestly to expand the
sensitivity of test kits to include group O HIV-1. |
| |
|
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