Premarket Notification
[510(k)] Procedures
Rod Perez, M.S.E.
Consumer Safety Officer
Division of Small Manufacturers, International and
Consumer Assistance
Western Canada 2009
Medical Device Amendments
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Signed into law on May 28, 1976
Gave FDA authority to regulate medical
devices
Defined a device [Sec. 201(h) of the Act]
Required classification of device types legally
on the market at that time
Led to classification of approximately 1,700
different generic types of devices and
grouped them into 19 medical specialties
Required premarket review of devices
What Is a Medical Device?
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an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar
or related article, including a component part, or
accessory which is:
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recognized in the official National Formulary, or the United
States Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body
of man or other animals, and which does not achieve any of
it's primary intended purposes through chemical action
within or on the body of man or other animals and which is
not dependent upon being metabolized for the achievement
of any of its primary intended purposes
Pre-Amendments vs.
Post-Amendments
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The FFD&C Act divided the arena of medical
devices depending on when the devices were
introduced into commercial distribution:
Pre-Amendments Devices (pre-May 28, 1976)
 Exempted (with conditions) from marketing
clearance
Post-Amendments Devices (post-May 28,
1976)
 Requires marketing clearance
Classification
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Classification regulations for individual
device types are found in 21 CFR Parts
862-892
Regulations describe the device type as
it existed prior to May 28, 1976
New indications for use or new
technologies are assigned new product
codes
What Is a Device Type?
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21 CFR 860.3(i) – Generic type of
device means a grouping of devices
that do not differ significantly in
purpose, design, materials, energy
source, function, or any other feature
related to safety and effectiveness, and
for which similar regulatory controls are
sufficient to provide reasonable
assurance of safety and effectiveness
Regulatory Class
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Class determines type of premarket submission
required by FDA
 Class I or II 510(k) Exempt
 Subject to limitations on exemptions covered
under 21 CFR xxx.9 (e.g., 862.9 to 892.9) •
 Class I or II Non-510(k) Exempt
 510(k) Required
 Class III
 PMA [510(k) for pre-Amendments devices until
515(b) calls for PMA or the device type is
reclassified]
Class I Exemptions
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Section 510(l) of the FD&C Act
All Class I Devices are Exempt except:
 those intended for a use which is of
substantial importance in preventing
impairment of human health, or
 those that present a potential for
unreasonable risk of illness of injury
Class II Exemptions
Section 510(m) of the FD&C Act
 Class II devices that do not require
510(k)s to provide reasonable
assurance of safety and effectiveness
 75 device classifications exempt*
 Final Rule November 3, 1998
* Subject to the Limitations on
Exemptions
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Limitations of Exemption
from 510(k) - Class I and II
Found in “.9” of Classification Chapters
 Four Limitations:
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If the device has an intended use that is
different from the intended use of a legally
marketed device in that generic type
If the device operates using a different
fundamental scientific technology than that
used by a legally marketed device in that
generic type
Limitations of Exemption
from 510(k) - Class I and II
Found in “.9” of Classification Chapters
 Four Limitations:
 There are specific limitations for in
vitro diagnostic devices
 There are device-specific limitations
as specified in a classification
regulation
Intended Use vs.
Indication for Use
No real clear FDA definition
- Intended use usually provides broad, general use
of the device and intent of the user
- Indications for use may refer to specific
population of the device use (adult vs. pediatric)
- Both intended use and indications for use can be
broad (surgical laser used for general surgical
procedures)
- Example of indication for use claim would be: for
surgical removal of kidney-stones from kidney.
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What Is a 510(k)?
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Premarket Notification
Section 510(k) of FD&C Act
21 CFR 807 Subpart E
Marketing clearance application
Allows FDA to determine substantial
equivalence (SE) relative to a legally
marketed medical device
What Is Not a 510(k)?
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A form
Establishment Registration
Device Listing
Premarket Approval (PMA)
510(k) & Classification
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A 510(k) is the classification
process for individual postamendments devices by:
 Finding the device substantially
equivalent (SE), OR
 Finding the device not
substantially equivalent (NSE)
When Is a 510(k) Required?
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When introducing a device to the
U.S. market for the first time
When changing the indications for
use for a marketed device
When making significant
modifications to a previously
cleared device
510(k) Exempt Devices
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Unfinished Devices (Components)
Class I (739) and Class II (74) devices exempt by
statute or regulation
Finished devices not sold in U.S. (Export-Only)
Devices covered under another 510(k)
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For Private Label Distribution
Pre-amendments devices
Custom Devices
Veterinary Devices
Who Must Submit a 510(k)?
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Manufacturers
Specifications Developers
Repackagers who modify the device or
its labeling
Relabelers who modify the labeling
(e.g., instructions for use)
Anyone who both manufactures and
distributes
Who Is Not Required to
Submit a 510(k)?
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Private Label Distributor who only adds
company name and wording such as:
 “Distributed by ___________” or
 “Manufactured for _________”
Repackager who does not alter the product
labeling
Distributor or U.S. Importer who furthers
marketing of the device, but does not alter
labeling or device specifications
What Is a Predicate?
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21 CFR Part 807.92(a)(3) - An identification of
the legally marketed device to which the
submitter claims equivalence. A legally
marketed device to which a new device may
be compared for a determination regarding
substantial equivalence is a device that was
legally marketed prior to May 28, 1976, or a
device which has been reclassified from class
III to class II or I (the predicate), or a device
which has been found to be substantially
equivalent through the 510(k) premarket
notification process
What Is a Predicate Device?
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A legally marketed device that does
not require Premarket Approval
(PMA) Examples include:
A Pre-Amendments device
 A device found Substantially
Equivalent (SE) by the FDA
 A reclassified device
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Substantial Equivalence
(SE)
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A device is “substantially equivalent” when
compared to a legally marketed or predicate
device if it:
 has the same intended use
 has the same technological characteristics
 has different technological characteristics
which do not raise new questions of safety
and effectiveness
 can be demonstrated to be as reasonably
safe and effective as the predicate device
Substantial Equivalence
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Substantial Equivalence must be established
relative to a legally marketed or predicate*
device that does not require a PMA
Acceptable “predicate types” include:
 A Pre-amendments device*
 A device found by FDA to be
Substantially Equivalent (SE), or
 A reclassified device*
*21 CFR 807.92(a)(3)
Substantial Equivalence
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SE comparison should account for:
intended use and indications for use
target population
anatomical sites
where used (hospital, home, ambulance, etc)
energy used and/or delivered
human factors
design
performance data (engineering, bench,
animal, design verification, human factors,
clinical)
Substantial Equivalence
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standards
materials
biocompatibility
compatibility with the environment and other
devices
sterility
electrical safety
mechanical safety
chemical safety
thermal safety
radiation safety
Not Substantially
Equivalent (NSE)
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There is no predicate device
Device has new intended use
Device has different technological
characteristics compared to the
predicate device and raises new
types of safety and effectiveness
questions
510(k) Decisions
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If found NSE:
 Device automatically classified as
Class III
 There are other mechanisms that
may be explored for U.S. marketing
 Reclassification, PMA, HDE, De
Novo
If found SE:
 Firm may proceed to market
Reclassification
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Changes in classification are based on FDA's
receipt of new information about a device
FDA may, on its own, or in response to an
outside petition, change a device's
classification by regulation
A manufacturer who wishes to have a device
reclassified to a lower class must convince
FDA that the less stringent class requirements
will be sufficient to provide reasonable
assurance of safety and effectiveness
Reclassification
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FDA notifies petitioners of determinations
made on petitions for reclassification by a
reclassification letter.
If a determination is made to reclassify a
device, FDA publishes a proposed rule to
reclassify in the Federal Register which
includes the scientific justification for
reclassification
A final rule is published in the Federal
Register which changes the reclassification
De Novo Process
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FDAMA amended Section 513(f)(2) to provide a new
mechanism for classifying new Class III devices for
which there is no identifiable predicate device
Provides a possible route to market low risk device
types
It allows the recipient of an NSE (not substantially
equivalent) letter to request a risk-based
classification determination to be made for the device
Does not apply to devices that have been classified
by regulation into class III
An applicant of a 510(k) who receives an NSE
determination can request a De Novo classification of
the product into Class I or II
De Novo Process
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The request must be in writing and sent within 30
days from the receipt of the NSE determination
The request should include:
 device description, labeling, reasons for the
recommended classification (into Class I or II),
and information to support the recommendation
There is a 60-day FDA review period
If FDA classifies the device into Class I or II, the
applicant will then receive an approval order to
market the device
If FDA determines that the device will remain in the
Class III category, the device cannot be marketed
until the applicant has obtained an approved PMA
Finished Device
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820.3(l) [QSR] - Finished device means
any device or accessory to any device
that is suitable for use or capable of
functioning, whether or not it is
packaged, labeled, or sterilized
Finished device is subject to 510(k)
requirements if it is both in final form
and for sale to an end user
Accessories and Components
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Component (820.3(c)) - Component means any raw
material, substance, piece, part, software, firmware,
labeling, or assembly which is intended to be
included as part of the finished, packaged, and
labeled device
Accessories - ”extras” (not defined in the regulations)
Accessories/components to a device take on the
same classification as the "parent" device unless they
are separately classified
A finished accessory or a finished component sold to
an end user is subject to 510(k) requirements
Convenience Kits
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Two or more separate types of finished
devices packaged together for the
convenience of the user is considered to be a
kit
The classification of the kit is based on the
highest classification of the devices that are
provided in the kit
Submissions for convenience kits should
identify all devices provided in the kit and
document the marketing status of each
device
Convenience Kits
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If a 510(k) submission is required, a kit
certification should be included. If a 510(k) is
not required, this information should be
maintained in Device Master Record
Certain convenience kits that meet the
criteria in the Convenience Kit Interim
Regulatory Guidance are under enforcement
discretion and do not require a 510(k)
Combination Products
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A combination product is a product comprised of two
or more regulated components (drug/device or
biologic/device) that are combined as a single entity
or labeled for use with a specified drug, device, or
biologic where both are required to achieve the
intended use, indication, or effect
FDA has developed InterCenter agreements which
establish the lead FDA Center for review and
oversight of combination products
The Office of Combination Products (OCP) assigns
review responsibility for combination products
OCP is also responsible for designating the
component of FDA with primary jurisdiction for the
premarket review and regulation of any product
requiring a jurisdictional designation
In Vitro Diagnostic Devices
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In vitro diagnostics are defined as medical devices
that analyze human body fluids, such as blood or
urine, to provide information for the diagnosis,
prevention, or treatment of a disease
Devices are subject to the Clinical Laboratory
Improvement Amendments (CLIA) of 1988
CLIA requirements vary according to the technical
complexity in the testing process and risk of harm in
reporting erroneous results
Three categories of testing based on the complexity
of the testing methodology:
 waived tests
 tests of moderate complexity, and
 tests of high complexity
In Vitro Diagnostic Devices
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Laboratories performing moderate- or highcomplexity 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
May use CeSub eSubmitter software to submit single
or bundled 510(k) submissions/supplements and
CLIA waiver and categorization applications
In vitro diagnostic products have special labeling
requirements and distribution restrictions under
21CFR 809, In Vitro Diagnostic Products for Human
Use
510(k) Content and Format
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Code of Federal Regulations (CFR)
21 CFR 807.87 – Content
21 CFR 807.90 – Format
Device-Specific Guidances
http://www.fda.gov/cdrh/guidance.html
CFR on the Internet at:
http://www.fda.gov/cdrh/devadvice/365.html
Device Advice
510(k) Content
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Submitter’s name, address, phone/fax #,
contact person, rep./consultant name,
establishment registration number
Device Classification Name, CFR number,
device class, ProCode
Common/usual name and trade/proprietary
name and model numbers
Copy of Medical Device User Fee Cover Sheet
CDRH Premarket Review Submission Cover
Sheet
510(k) Content
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Identification of legally marketed device(s) to
which substantial equivalence is claimed
Compliance with section 514 Special Controls
Indications for Use Statement
Truthful and Accurate Statement
Standards Data Report, FDA Form 3654 (if
applicable)
If 510(k) has clinical trial - FDA Form 3674
510(k) Content
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Photographs, engineering drawings
Substantially equivalent statement and
detailed comparison with predicate device
Statement of similarities and/or differences
with predicate device
Supporting data for device modifications
510(k) Summary or 510(k) Statement per
21 CFR 807.92 & 807.93
510(k) Content
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Proposed labeling (package inserts,
service manuals, instructions for use,
advertising and/or promotional
materials)
Adherence to voluntary standards
Financial Certification or Disclosure
Statement or both
510(k) Content
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Performance Data (bench, animal, clinical)
Photographs, Engineering Drawings
Biocompatibility, Toxicology, Sterilization and
Shelf Life data (as applicable)
Electromagnetic Compatibility and Electrical
Safety data (as applicable)
Software/Hardware Information (as
applicable)
Device-specific requirements per available
guidance documents
510(k) Content
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Class III 510(k)s must include:
 Certification that search of scientific
literature has been conducted, and
 Summary of available adverse S&E
data with all specific citations from
the scientific literature
Clinical Data Requirements
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10-15% of all 510(k)s require some
clinical data
May be required when intended use or
technology or materials differ from the
predicate device
Must be collected under the
Investigational Device Exemptions (IDE)
regulations (21 CFR Part 812)
Request for Additional
Information
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For administratively incomplete
submissions (Refuse to Accept)
When additional regulatory information
or performance data is required to
demonstrate substantial equivalence
Request for Additional
Information
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Reviewer request made via telephone
or letter
Additional information should be sent to
the Document Mail Center within 30
days.
Submitter may request extension of up
to 180 days
FDA Review Procedure
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Application Log-in
Division Acceptance
Assignment to Reviewer/Review Group
ODE Review
Decision Letter Issued By Reviewing
Division
SE Decision Made Public Within 30 days
Expedited Review
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Expedited review of devices subject to 510(k)
will generally be considered when a device
offers a potential for clinically meaningful
benefit as compared to the existing
alternatives (preventative, diagnostic, or
therapeutic) or when the new medical device
promises to provide a revolutionary advance
(not incremental advantage) over currently
available alternative modalities.
Expedited Review
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Criteria for expedited review:
Device is intended to treat or diagnose a lifethreatening or irreversibly debilitating disease or
condition, and
Device addresses an unmet medical need as
demonstrated by one of the following:
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breakthrough technology that provides a significant,
clinically meaningful advantage over existing approved
technology or alternative treatments; or
no approved alternative treatment or means of diagnosis
exists; or
the availability of the device is in the best interest of patients
Confidentiality and
Misbranding of a 510(k)
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21 CFR 807.95 – Confidentiality
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The existence of 510(k)s under review (pending)
marketing clearance will remain confidential. “SE”
510(k)s are made public within 30 days on CDRH
Homepage
21 CFR 807.97 – Misbranding
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Any representation that creates an impression of
official approval of a device because of complying
with the premarket notification regulations is
misleading and constitutes misbranding
FDA Review Times
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FDA Decision: 90 days
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First AI Letter: 75 days
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Second or Later AI Letter: 60 days
MDUFMA Changes
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User Fees
Bundling
Third Party Review of 510(k)s
Class II Exemptions
Single Use Disposable (SUD)
Reprocessed Devices
The 510(k) Paradigm
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Traditional 510(k)
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Special 510(k)
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Abbreviated 510(k)
Traditional 510(k)
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Full 510(k)
Contains all elements listed in 21
CFR 807.87
Reviewed in 90 calendar days
Special 510(k)
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Manufacturer modifies own legally
marketed Class I, II, or III device &
determines that a 510(k) is required
Device modification is significant
Modification does not alter the
fundamental scientific technology
Not a new intended use
Special 510(k)
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Applicant assesses modification in
accordance with 21 CFR 820.30 (Design
Controls)
Applicant submits 510(k) with a
“Declaration of Conformity” to Design
Controls
No evaluation of data
Reviewed within 30 days
Special 510(k) Content
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Contains all elements listed in 21 CFR 807.87
Coversheet – “Special 510(k): Device
Modification”
Name of Marketed Device and 510(k) number
Description of Modified Device and
Comparison to Cleared Device
Intended Use
Proposed Labeling
Design Controls
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All manufacturers (including specification
developers) of Class II and III devices and
select Class I devices (listed below) are
required to follow design controls (§820.30)
during the development of their device
The design control requirements are basic
controls needed to ensure that the device
being designed will perform as intended when
produced for commercial distribution.
Design Controls
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The manufacturer must have procedures in place and
must maintain documentation in the design history
file to demonstrate compliance with the design
control requirements of §820.30 and completion of
the activities identified in the design plan
The manufacturer (including specification developer)
must establish and maintain procedures to control
the design of the device in order to ensure that
specified design requirements are met
FDA will evaluate the adequacy of manufacturers'
compliance with design control requirements during
routine quality systems inspections for all classes of
devices subject to design control
Abbreviated 510(k)
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Applicant is submitting a 510(k) for a
new Class II device
Device is subject to Special Controls
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Guidance Document; or
Recognized Standard
Applicant complies with available
device-specific Guidance Document
and/or conforms to Standard
Abbreviated 510(k)
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Manufacturers may submit:
A declaration of conformity to a
recognized standard
A statement that the device will
conform to a recognized standard when
finally marketed
A statement that the product will
conform to a non-recognized standard
(decided on case-by-case basis)
Abbreviated 510(k) Content
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Contains all elements listed in 21
CFR 807.87
510(k) submitted with Summary
information on compliance with
guidance or standard
Reviewed within 90 days
Use of Standards
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Conformance with recognized consensus standards
can provide a reasonable assurance of safety and/or
effectiveness for many aspects of medical devices
Information submitted on conformance with such
standards will have a direct bearing on safety and
effectiveness determinations made during the review
of premarket submissions
If any 510(k) contains a declaration of conformity to
the recognized consensus standards, this may
eliminate the need to review the actual test data for
those aspects of the device addressed by the
standards
Use of Standards
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FDA recognizes certain consensus standards.
If the device complies to an FDA recognized
standard, the applicant may provide a
declaration of conformity to the standard and
use the Abbreviated 510(k) submission
method. Conformance to FDA recognized
standards are voluntary and may be used to
demonstrate performance or safety of a
device.
Using Standards:
Three Alternatives
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FDA-recognized standard with a
declaration
FDA-recognized standard without a
declaration
Non-recognized standard
Use of FDA-Recognized
Standard With a Declaration
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FDAMA approach [§ 514(c)]
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Manufacturer elects to conform to
recognized standard; includes declaration
in 510(k)
Manufacturer must have supporting data at
time of 510(k) submission
FDA legally bound to accept declaration to
meet applicable requirements
Review Procedures
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Described in previous guidance documents
 Ensure standard is applicable to device
 Determine extent to which standard
addresses SE issues; ensure 510(k)
contains information for remaining
requirements
 Consult supervisor and division director if
concerned about adequacy of standard
 Ensure completeness of declaration
 Indicate reliance on declaration in review
document
Use of FDA-Recognized Standard
Without a Declaration
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Pre-FDAMA approach, but strengthened
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Manufacturer intends to conform to
recognized standard and includes
statement in 510(k) to this end
Manufacturer must have supporting data
before marketing
FDA normally accepts statement to meet
applicable requirements
Review Procedures
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Same as for 510(k) with declaration except:
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Format of statement not prescribed
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Content should be specific and unequivocal
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Reliance on statement is documented in
review document
Use of Non-Recognized
Standard
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Manufacturer may elect to submit a
statement for a non-recognized
standard
Less assurance that standard will
be acceptable
Review Procedures
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If statements have previously been relied
upon for this standard, may proceed
 Follow procedures for use of recognized
standard without a declaration
If not:
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Need to assess whether standard
adequately addresses SE issues
May need to request additional
information
Device Modifications
Requiring a New 510(k)
A new 510(k) must be submitted for a legally
marketed device that is about to be
significantly changed or modified.
 21 CFR 807.81(a)(3)
 (i) A change or modification in the device
that could significantly affect the safety or
effectiveness of the device; OR
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(ii) A major change or modification in the
intended use of the device.
Device Modifications
Requiring a New 510(k)
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Changes in Indications for Use and/or
Fundamental Scientific Technology
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Changes in design, materials, chemical
composition, energy source, technological
characteristics, sterilization, software, performance
specifications, or manufacturing process
Changes in Product Labeling
Guidance: Deciding When to Submit a 510(k)
for a Change to an Existing Device”
(01/10/97)
Significant Changes in Technology,
Engineering, and Performance
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Broad span of design activities
All changes in technology,
engineering, and performance are
evaluated and validated according
to GMP requirements to determine
if a new 510(k) notice must be filed
Significant Changes in Technology,
Engineering, and Performance
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Changing the control mechanism (analog
to digital control, pneumatic to electronic
control)
Changing the operating principle
Changing the energy source
Changing the sterilization procedure in a
manner that affects performance
specifications or reduces the sterility
assurance level
Significant Materials Changes
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A new 510(k) notice may be required for
changes in the basic type of material (i.e.,
metal versus polymer) or the material
formulation
Criteria for determining whether changes in
the type of material or the formulation of the
material require a new 510(k) differ for
implantable devices and non-implantable
devices
Significant Materials Changes
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For non-implantable devices, a new 510(k)
generally should be submitted if:
 the new material is likely to contact body
fluids or tissues and
 new biocompatibility testing of the material
is required by ISO 10993-1
For implantable devices, a new 510(k) should
be submitted if the new material is likely to
contact body fluids or tissues
Significant Materials Changes

In determining whether a new
510(k) must be submitted,
manufacturers also should consider
whether the change in materials
alters the performance
specifications for the device
Significant Labeling Changes




Expanding the indications for use to a
new, distinct patient population
Changing the device labeling of a
single-use device to permit reuse
Switching from prescription to over-thecounter (OTC)
Deleting a contraindication
Modifications That Do Not
Require a 510(k)




Change in trade name
Adding additional sizes within the
specifications
Downsizing device functionality
Deleting Indications for Use
Non-Significant Changes in
Technology, Engineering and
Performance

Changes to the performance specifications,
the dimensional specifications, and the
software/firmware may not require a new
510(k) if:



They do not affect the indications for use
They do not require supporting clinical data on S
& E for purpose of determining substantial
equivalence, and
The results of design validation do not raise new
issues of safety and effectiveness
Non-Significant Materials
Changes

A new 510(k) notice generally is
not required for a change in the
raw material supplier, provided that
the vendor supplies the material
according to the same/similar
specification
Non-Significant Labeling
Changes




Restricting the indications for use to a
subset of the original indications
Expanding the population with similar
diagnosis, prognosis, etc.
Changing the warnings or precautions
Revising the labeling to clarify the
instructions for use
The 513(g) Process

“Within 60 days of the receipt of a written
request of any person for information
respecting the class in which a device has
been classified or the requirements applicable
to a device under this Act, the Secretary shall
provide such person a written statement of
the classification (if any) of such device and
the requirements of this Act applicable to the
device.”
513(g) Typical Inquiries




To determine whether a product is subject to
FDA regulations
To determine whether a device is exempt
from the 510(k) requirements of the Act.
To determine whether a 510(k) is needed for
a modification to one's device
To determine the least burdensome
regulatory pathway for a device which
introduces a new technology or a new
intended use
513(g) User Fees FY 2010

Standard Fee: $2,940.00

Small Business Fee $1,470.00
The 513(g) Review Process

FDA responses to requests for
information about the regulatory
requirements applicable to a particular
device DO NOT constitute FDA
clearance or approval for distribution of
that particular device in the United
States
Content of a 513(g) Request




A Cover Letter
A complete device description
A concise Indication(s) for Use
Statement
Either proposed labeling or labeling of a
marketed similar product/device
Third Party Review Program:
Accredited Persons (AP)




Authorized by §523 of the FFD&C Act
Gives manufacturers the option of using accredited,
non-Federal organizations to review 510(k)s for low
and moderate risk devices (in place of FDA’s review)
Usually more timely and accessible process with
quicker marketing clearance decisions
Better allocation of FDA’s resources
Third Party Review Program:
Accredited Persons (AP)




APs have technical/standards/regulatory
expertise
No FDA 510(k) fee (AP charges fee)
AP reviews 510(k) and then makes
recommendation to FDA
FDA issues 510(k) decision within 30 days
Statutory Limitation
§ 523(a)(3)
Accredited Persons may not review:

Class III devices

Class II devices that:


are permanently implantable

are life sustaining/supporting, or

require clinical data in 510(k)s
510(k)s that require CBER/CDER lead or consulting
review (e.g., drug/device combination products)
Eligible Devices



More than 670 eligible Class I and
Class II device types
60% of all 510(k) submissions
Eligible device list accessible from:
www.fda.gov/cdrh/thirdparty
Accredited Organizations
Accredited for expansion pilot and non-pilot devices:

TUV America, Inc.

Underwriters Laboratories, Inc.

TUV Rheinland of North America, Inc.

CITECH

Entela, Inc.

California Department of Health Services

Intertek Testing Services

KEMA Quality, BV (Netherlands)

Regulatory Technology Services, LLC
Accredited for non-pilot devices only:

Center for Measurement Standards, ITRI (Taiwan)

British Standards Institution (United Kingdom)

Cheiroon, BV (Netherlands)

NIOM Scand. Inst. of Dental Materials (Norway)

MedTech Review, LLC
Accreditation of Third Parties


FDA serves as accreditation body
Emphasis is on adequacy of:
 Personnel and procedures to
ensure competent reviews
 Controls to prevent conflict of
interest
When to Think Twice


Special 510(k)s
Device eligibility uncertain
(e.g., may require clinical data)

Complex, precedent-setting submissions

AP lacks relevant experience
How To Get Started


Check eligible device list
Contact AP(s) and ask about:



Review timeframe
Estimated cost
Experience

Obtain quote

Sign contract/submit 510(k)
Devices Which Need a PMA

New Devices


Not Substantially Equivalent
Transitional Class III Devices


regulated as drugs prior to the Medical Device
Amendments (original NDA# maintained)
any device approved via the New Drug
Application (NDA) process is now governed by
the PMA regulations

Includes gauze, adhesive tape, tampons, dialysis
fluid, denture cushions
CDRH eCopy Initiative




Manufacturers submit an exact
duplicate of a premarket submission in
electronic form
Paper copies must still be submitted
Electronic copy can replace one of the
required paper copies
An eCopy may be submitted for any
premarket submission: 510(k), PMA,
IDE, HDE, 513(g)
CDRH eCopy Initiative

Benefits




Document is immediately loaded into our
electronic system and available for use by
review staff (including navigational tools)
Saves CDRH resources (time and $$)
Specific format is needed for PDF files
Information available at:
http://www.fda.gov/cdrh/elecsub.html
Radiation-Emitting Products


If your medical device also emits electronic
product radiation, additional requirements
apply under the Electronic Product Radiation
Control Provisions of the Food, Drug and
Cosmetic Act
Electronic product radiation means:
 any ionizing or non-ionizing
electromagnetic or particulate radiation, or
 any sonic, infrasonic, or ultrasonic wave
which is emitted from an electronic product
as the result of the operation of an
electronic circuit in such product
Radiation-Emitting Products



Included are lasers, ultraviolet lamps,
microwave ovens, ultrasound therapy devices
and medical diagnostic x-ray equipment
Requirements may include submission of
reports to FDA, compliance with applicable
radiation safety performance standards,
retention of certain records, and reporting of
accidental radiation occurrences or product
defects to FDA
http://www.fda.gov/RadiationEmittingProducts/default.htm
Helpful Websites

Medical Device User Fee Modernization Act

Industry (Medical Devices)

CDRH Learn
www.fda.gov/cdrh/mdufma/index.html
www.fda.gov/MedicalDevices/ResourcesforYou/In
dustry/default.htm
www.fda.gov/Training/CDRHLearn/default.htm

Importing and Exporting Medical Devices
www.fda.gov/cdrh/k863.html
Helpful Websites

International Information (Devices)
www.fda.gov/MedicalDevices/DeviceRegulationandGuida
nce/InternationalInformation/default.htm

CDRH Device Advice
www.fda.gov/cdrh/devadvice

CDRH Standards Program
www.fda.gov/cdrh/stdsprog.html

Medical Device Databases
www.fda.gov/MedicalDevices/DeviceRegulationandGuida
nce/Databases/default.htm
Questions


FDA’s CDRH webpage:
http://www.fda.gov/cdrh
DSMICA:
- e-mail: [email protected]
- fax: 301-847-8149
- phone: 1-800-638-2041 or 301-7967100
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