IVD Product Information
FDA maintains public databases and lists of information about
in vitro diagnostic devices (IVDs). This section explains the data
that FDA collects and gives links to FDA's databases of clearances,
approvals, certification programs, CLIA '88 categorizations, device problems,
and recalls.
Finding Information about IVD Products
FDA maintains a number of databases containing information about
in vitro diagnostic devices (IVDs) use for laboratory testing. You
can use these databases to find what products FDA has cleared or
approved, review the studies FDA used to evaluate the products,
or research problems that occurred with different products.
Premarket Information
When a manufacturer wants to begin selling an IVD product, it must
first submit a premarket notification or premarket approval application
to FDA. Premarket notification is generally reserved for lower risk
products, and premarket approval is usually reserved for new technology
and higher risk products.
Premarket Notification [510(k)]
In the premarket notification process, new products are compared
to ones that are already on the market. If FDA finds the new products
to be substantially equivalent to predicate devices on the market,
it clears the product.
All products cleared through the premarket notification program
[510(k)] are listed in the 510(k) database. This database includes
the name of the product, the 510(k) number, and a copy of the clearance
letter indicating the sponsor of the submission. It also often includes
the intended use of the device and the manufacturer's summary.
The manufacturer's summary gives information on the studies done
to demonstrate that the new device is as safe and effective as its
predicate. FDA does not review it in depth. Instead of a summary,
manufacturers may substitute a statement saying that the summary
will be available upon request. In this case, you will not find
the summary in the 510(k) database, but you can receive copies of
it directly from the sponsor. While the detail and format of the
summary vary, these documents can provide considerable information
about the quality and nature of a particular product.
De novo applications are 510(k)s that have no predicates, but because
they are considered to be low risk, they are reviewed under the
510(k) program. Their 510(k) summaries contain information on the
studies that showed they were safe and effective. De novo 510(k)s,
and 510(k)s that subsequently cite them as predicate devices, usually
have special control guidance documents that give information about
how to obtain clearance.
Premarket Approval Application (PMA)
In the premarket approval application process, the sponsor presents
data to demonstrate that a new product is safe and effective for
its intended use. If FDA finds the new product to be safe and effective,
it approves the product.
All products approved through the premarket approval application
program (PMA) are listed in the PMA database. Each entry includes
a summary of safety and effectiveness (SS&E) outlining in detail
the scientific information used to obtain premarket approval. The
sponsor submitting the PMA drafts the SS&E, but the final version
is written and edited by FDA review staff.
Clinical Laboratory Improvement Amendments (CLIA '88)
FDA assigns a regulatory category to all commercially marketed
in vitro diagnostic tests, based on their potential risk to public
health.
The CLIA '88 database lists all commercially marketed in vitro test
systems that FDA has categorized under the Clinical Laboratory Improvement
Amendments (CLIA '88) since January 31, 2000. It also contains all tests
categorized by the Centers for Disease Control and Prevention (CDC)
prior to that date. You can search the CLIA '88 database by test system
name, analyte name, complexity, specialty, or date of categorization.
Many of the records also contain links to the 510(k) summary or
the PMA summary of safety and effectiveness.
Postmarket Product Problems
FDA's databases of device problems are available to the public.
The Medical and User Facility Device Experience (MAUDE) give information
on medical devices that may have malfunctioned contributed to a
death or serious injury. You can also get information about recalls
from FDA's list of medical device recalls.
Other Sources of Information
Performance of tests may vary after enters the marketplace. Information
on the expected performance of an IVD is presented in its labeling
or package insert. You can obtain details about performance in actual
clinical laboratories by asking the manufacturer for a list of users
to contact. For best results, you should contact laboratories with
operational environment similar to your own. You can also find information
on real world testing by analyzing the scientific literature, by
monitoring information on test performance through proficiency testing
programs, or by contacting any beta testing sites the sponsor used
in product development.
Cleared Products
The 510(k) database lists all products that FDA has cleared through
the premarket notification process. Manufacturers must submit a
premarket notification or 510(k) if they intend to introduce a device
into commercial distribution for the first time or reintroduce a
device that will be significantly changed or modified to the extent
that its safety or effectiveness could be affected. You can search
the database of releasable 510(k)s by 510(k) number, applicant,
device name or FDA product code. Many of the records also contain
links to the manufacturer's 510(k) summary. FDA updates this database
monthly.
See also: Information on Releasable
510(k)s
Approved Products
The premarket approval (PMA) database lists all products that FDA
has approved through the premarket approval process. Manufacturers
must submit a premarket approval application for all class III devices.
In a considering a PMA application, FDA performs a detailed scientific
review of the product's safety and effectiveness. An approved PMA
is, in effect, a private license granted to the applicant for marketing
a particular medical device. You can search the PMA database by
PMA number, applicant, product trade name, or FDA product code.
Most of the records contain links to the summary of safety and effectiveness.
FDA updates this database monthly.
See also: Information on Premarket
Approval Applications
CLIA '88 Categorization
The CLIA '88 database lists all commercially marketed in vitro test
systems that FDA has categorized under the Clinical Laboratory Improvement
Amendments (CLIA '88) since January 31, 2000. It also contains all tests
categorized by the Centers for Disease Control and Prevention (CDC)
prior to that date. You can search the CLIA '88 database by test system
name, analyte name, complexity, specialty, or date of categorization.
Many of the records also contain links to the 510(k) summary or
the PMA summary of safety and effectiveness. FDA updates this database
monthly.
For questions about CLIA '88 categorization, contact CLIA@CDRH.FDA.GOV.
See also: CLIA '88 - Clinical Laboratory Improvement
Amendments
Reports of Problems
The Manufacturer and User Facility Device Experience (MAUDE) database
contains reports that have been submitted to FDA from individuals
or user facilities when they believe a medical device has malfunctioned,
or when the device may have caused or contributed to a death or
serious injury. You can search the MAUDE database by brand name,
product code, manufacturer, or date. You can also search the database
using a brief description of the product (full-text search).
See also: Medical
Device Reporting
Manufacturer Certification Programs
FDA encourages manufacturers to have their devices tested and certified
when and appropriate certifying body exists.
The CDC website provides information on manufacturer certification
programs for total cholesterol, HDL cholesterol, and LDL cholesterol.
It includes lists of analytical systems that are certified by the
Cholesterol Reference Method Laboratory Network (CRMLN) as having
documented traceability to the national reference system for cholesterol.
The Department
of Transportation’s (DOT) rule, 49 CFR Part 40, describes
required procedures for testing of Evidential Breath Testing Devices
and Alcohol Screening Devices to meet DOT's specifications.
The purpose of this program is to standardize glycated hemoglobin
test results so that clinical laboratory results are comparable
to those reported in the Diabetes Control and Complications Trial
(DCCT) where relationships to mean blood glucose and risk for vascular
complications have been established. A key component of the program
is the Reference Laboratory Network. The network interacts with
manufacturers of GHB methods to assist them first in standardizing
their methods and then in providing comparison data for certification
of traceability to the DCCT.
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