Each person who wants to market Class I, II and some III devices
intended for human use in the U.S. must submit a 510(k) to FDA at
least 90 days before marketing unless the device is exempt from
510(k) requirements. There is no 510(k) form but instead a format
for the submission described in 21
CFR 807 and in the pages that follow.
A 510(k) is a premarketing submission made to FDA to demonstrate
that the device to be marketed is as safe and effective, that is,
substantially equivalent (SE), to a legally marketed device that
is not subject to premarket approval(PMA). Applicants must compare
their 510(k) device to one or more similar devices currently on
the U.S. market and make and support their substantial equivalency
claims. A legally marketed device is a device that was legally marketed
prior to May 28, 1976 (preamendments device), or a device which
has been reclassified from Class III to Class II or I, a device
which has been found to be substantially equivalent to such a device
through the 510(k) process, or one established through Evaluation
of Automatic Class III Definition. The legally marketed device(s)
to which equivalence is drawn is known as the "predicate"
device(s).
Applicants must submit descriptive data and, when
necessary, performance data to establish that their device is SE
to a predicate device. Again, the data in a 510(k) is to show comparability,
that is, substantial equivalency (SE) of a new device to a predicate
device.
What is Substantial Equivalence
Unlike PMA, which requires demonstration of reasonable safety and
effectiveness, 510(k) requires demonstration of substantial equivalence.
SE means that the new device is as safe and effective as the predicate
device(s).
A device is SE if, in comparison to a predicate device it:
has the same intended use as the predicate device; and
has the same technological characteristics as the predicate
device; or
has different technological characteristics, that do not raise
new questions of safety and effectiveness, and the sponsor demonstrates
that the device is as safe and effective as the legally marketed
device.
A claim of substantial equivalence does not mean the new and predicate
devices must be identical. Substantial equivalence is established
with respect to intended use, design, energy used or delivered,
materials, performance, safety, effectiveness, labeling, biocompatibility,
standards, and other applicable characteristics. Detailed information
on how FDA determines substantial equivalence can be found in the
Premarket Notification Review Program
6/30/86 (K86-3) blue book memorandum.
Until the applicant receives an order declaring a
device SE, they may not proceed to market the device. Once the device
is determined to be SE, it can then be marketed in the U.S. If FDA
determines that a device is not SE, the applicant may resubmit
another 510(k) with new data, file a reclassification
petition, or submit a premarket approval application (PMA).
The SE determination is usually made within 90 days and is made
based on the information submitted by the applicant.
Who is Required to Submit a 510(k)
The Food, Drug and Cosmetic (FD&C) Act and 510(k) regulations
in 21 CFR 807 do not specify who must apply for a 510(k) - anyone
may do so. Instead, they specify which actions, such as introducing
a device to the U.S. market, require a 510(k) submission.
Based on the specified actions, the following four categories of
parties must submit a 510(k) to the FDA:
Domestic manufacturers introducing a device to the U.S. market;
Finished device manufacturers have to submit a 510(k) if they
assemble a device according to their own specifications and market
it in the U.S. However, manufacturers of device components are
not required to submit a 510(k) unless such components are promoted
for sale to an end user as replacement parts. Also, contract manufacturers,
those firms assembling devices on contract according to someone
else's specifications, are not required to submit a 510(k).
Specification developers introducing a device to the U.S. market;
FDA views specification developers almost the same as manufacturers.
These are persons who develop specifications for a finished device,
but have it manufactured under contract by another firm or entity.
The specification developer submits the 510(k), not the contract
manufacturer.
Repackers or relabelers who make labeling changes, or whose
operations significantly affect the device.
Repackagers or relabelers may be required to submit a premarket
notification if they significantly change the labeling or otherwise
affect any condition of the device. Here you must ascertain if
you are significantly changing labeling, by modifying manuals,
deleting or adding warnings, contraindications, etc., and if your
packaging operation could alter the condition of the device. However,
most repackagers or relabelers are not required to submit a 510(k).
Foreign manufacturers/exporters or U.S. representatives of foreign
manufacturers/exporters introducing a device to the U.S. market.
When a 510(k) is Required
A 510(k) is required when:
Introducing a device into commercial distribution (marketing)
for the first time. After May 28, 1976 (effective date of the
Medical Device Amendments to the FD&C Act), anyone who wants
to sell a device in the U.S. has been required to make a 510(k)
submission at least 90 days prior to offering the device for sale,
even though it may have been under development or clinical investigation
before that date. If your device was not marketed by your firm
before May 28, 1976 a 510(k) is required. Refer to the guidance
entitled Deciding When to Submit
a 510(k) for a Change to an Existing Device
You propose a different intended use for a device which you
already have in commercial distribution. The 510(k) regulation
(21
CFR 807) specifically requires a premarket notification submission
for major changes in intended use. Intended use is indicated
by claims made for a device in labeling or advertising. However,
most, if not all changes in intended use will require a 510(k).
There is a change or modification of a device you already market,
if that change could significantly affect its safety or effectiveness.
The burden is on you to decide whether or not a modification
could significantly affect safety or effectiveness. Whatever
your conclusion, make a record which should be reflected in
your device master record and change control records, required
under the medical device good manufacturing practices. Then,
if you're challenged, you will be able to document that in good
faith you evaluated the change.
A new, complete 510(k) application is required
for changes or modifications to an existing device, where the
modifications could significantly affect the safety or effectiveness
of the device, or the device is to be marketed for a new or
different indication.
When a 510(k) is Not Required
The following are 7 examples of when a 510(k) is not required.
If you sell unfinished devices to another firm for further processing,
including components to be used in the assembling of devices by
other firms. However, if your components are to be sold directly
to end users as replacement parts, a 510(k) is required
If your device is not being marketed or commercially distributed.
You do not need a 510(k) to develop, evaluate, or test a device.
This includes clinical evaluation. It is important to mention
that if you do perform clinical trials with your device, you may
be subject to the Investigational Device
Exemption (IDE) Regulation.
If you distribute other firm's domestically manufactured devices
you need not submit a 510(k). You may place a label on the device
"Distributed by ABC Firm", and sell it to end users
without submission of a 510(k).
In most cases if you are a repackager or a relabeler you are
not required to submit a 510(k) if the existing labeling or condition
of the device is not significantly changed.
If your device was legally in commercial distribution before
May 28, 1976, you do not have to submit a 510(k) unless it has
been modified or there has been a change in its intended use.
These devices are "grandfathered".
If you are an importer of a foreign made medical device, a 510(k)
is not required if:
510(k) has been submitted by the foreign manufacturer and
received marketing clearance, or
510(k) has been submitted by an importer on behalf of the
foreign manufacturer and has received marketing clearance. If
one importer submits a 510(k) on behalf of the foreign manufacturer,
all other importers of that device, imported from the same foreign
manufacturer (the 510(k) Holder) are not required to submit
a 510(k) for that device.
If your device is exempted from this requirement by final classification
regulation subject to the limitations on exemptions. That means
certain Class I or II devices can be marketed for the first time
without having to submit a 510(k). A compilation of the Class
I and II exempted devices can be found in the MEDICAL
DEVICE EXEMPTIONS page.
The Modernization Act and the 510(k) Submission
Process - Different Types of Submissions for Differing Situations
To streamline the evaluation of premarket notifications for the
reserved Class I devices, Class II devices subject to premarket
notification, and preamendments Class III devices for which FDA
has not yet called for PMAs, the Agency has developed The
New 510(k) Paradigm which in certain instances presents device
manufacturers with two new optional approaches for obtaining marketing
clearance for devices subject to 510(k) requirements. The document
contains the following reference chart for use in determining which
type of 510(k) is suitable for a given set of circumstances.
While the New Paradigm maintains the Traditional
510(k) method of demonstrating substantial equivalence under
section 510(k) of the Act, it also presents the Special
510(k):Device Modification option, which utilizes certain aspects
of the Quality System Regulation, and the Abbreviated
510(k) option, which relies on the use of guidance documents,
special controls, and recognized standards to facilitate 510(k)
review. Use of either alternative, however, does not affect FDA's
ability to obtain any information authorized by the statute or regulations.
Additional guidance on the new 510(k) paradigm can be found in "Frequently
Asked Questions on the New 510(k) Paradigm."
In vitro diagnostics are medical devices that analyze human body
fluids, such as blood or urine, to provide information for the diagnosis,
prevention, or treatment of a disease. The device classification
for these devices can be found under 21
CFR 862, 21
CFR 864, and 21
CFR 866.
Clinical Laboratory Improvement Amendments (CLIA) of 1988
In addition to FDA regulation under the Food, Drug, and Cosmetic
Act, in vitro diagnostic (IVD) devices are also subject to the Clinical
Laboratory Improvement Amendments (CLIA) of 1988. This law established
quality standards for laboratory testing and an accreditation program
for clinical laboratories.
The requirements that apply vary according to the technical complexity
in the testing process and risk of harm in reporting erroneous results.
The regulations established three categories of testing on the basis
of the complexity of the testing methodology: waived tests, tests
of moderate complexity, and tests of high complexity. Laboratories
performing moderate- or high-complexity testing or both must meet
requirements for proficiency testing, patient test management, quality
control, quality assurance, and personnel. These specific requirements
do not apply to tests in the waived category.
In January 2000 the categorization of commercially marketed in
vitro diagnostic tests under CLIA was tranferred from the Center
for Disease Control and Prevention (CDC) to FDA. CDRH's Office of
of In Vitro Diagnostic Device Evaluation and Safety (OIVD) determines
the appropriate complexity categories for clinical laboratory devices
as they evaluate premarket submissions. Waived products, devices
exempt from premarket notification, and devices under premarket
review by other FDA Centers are also processed by OIVD. Responsibilities
currently assigned to CDC, including review of test systems, assays,
or examinations not commercially marketed as IVD products, will
remain with CDC.
Below is a list of CLIA Program Information Resources:
Additional information on assignment of CLIA categories by FDA
can be found on the Internet at http://www.fda.gov/cdrh/clia/
Additional IVD Guidance
For additional information on in vitro diagnostics devices, please
visit the Office of In Vitro Diagnostic Device Evaluation and Safety
(OIVD) website at http://www.fda.gov/cdrh/oivd/
Medical devices reviewed by the Center for Biologic,
Evaluation, Research
The Center for Biologic, Evaluation, Research (CBER) has expertise
in blood, blood products, and cellular therapies as well as the
integral association of certain medical devices with these biological
products. To utilize this expertise marketing and investigational
device submissions (Premarket Notification, Premarket Approval,
and Investigational Device Exemption) for medical devices associated
with the blood collection and processing procedures as well as those
associated with cellular therapies are reviewed by CBER. Although
these products are reviewed by CBER, the medical device laws and
regulations still apply.
Center for Biologics Evaluation and Research
Office of Communication, Training and Manufacturers Assistance (HFM-43)
1401 Rockville Pike, Room 200N
Rockville, MD 20852-1448 U.S.A.
Telephone Number: 301-827-2000 or 800-835-4709
Fax Number: 301-827-3843
Third Party Review Program
The Center for Devices and Radiological Health (CDRH) has implemented
a Third Party Review Program. This program provides an option to
manufacturers of certain devices of submitting their 510(k) to private
parties (Recognized Third Parties) identified by FDA for review
instead of submitting directly to CDRH. For more information on
the program, eligible devices and a list of Recognized Third Parties
go to Third Party Review Program
Information page.
