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This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s.
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GUIDANCE ON THE CONTENT OF PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR PISTON SYRINGES |
 |
April 1993
GUIDANCE ON THE CONTENT OF PREMARKET NOTIFICATION
[510(K)] SUBMISSIONS FOR PISTON SYRINGES
I. INTRODUCTORY INFORMATION
A. Scope
This document establishes the 510(k) review requirements for piston
syringes. The piston syringe may or may not include a hypodermic needle
attached to the barrel. Examples of devices within this generic type
include insulin syringes, syringes with anti-needlestick features, control
syringes, and cartridge or pen syringes not including the cartridge itself.
Accessory devices, such as dispensing pens and syringe holders, are also
included within this type of device.
EXCLUSIONS
This document does not include pre-filled syringes since they are
regulated as drugs or biologics. This document also does not include fluid
injectors (as described in 21 CFR 880.5430) or irrigating syringes (as
described in 21 CFR 880.6960).
B. Purpose
This guidance is intended to:
1. assist persons (manufacturers, distributors, or
importers) in organizing premarket notifications for
piston syringes;
2. achieve consistency in meeting of requirements and in
the presentation of information; and
3. guide FDA review staff in conducting and documenting
the review of premarket notifications for piston
syringes.
C. Definitions
1. Piston Syringe: described in FDA regulation,
880.5860, as "a device intended for medical purposes
that consists of a calibrated hollow barrel and a
movable plunger. At one end of the barrel there is a
male connector (nozzle) for fitting the female
connector (hub) of a hypodermic single lumen needle.
The device is used to inject fluids into, or withdraw
fluids from, the body."
2. Hypodermic Single Lumen Needle: described in FDA
regulation, 880.5570, as "a device intended to inject
fluids into, or withdraw fluids from, parts of the body
below the surface of the skin. The device consists of
a metal tube that is sharpened at one end and at the
other end joined to a female connector (hub) designed
to mate with a male connector (nozzle) of a piston
syringe or an intravascular administration set."
3. Control Syringe: a piston syringe having a ring
attachment to the barrel, plunger, or both to reduce
hand fatigue, increase control of the syringe, and
allow ease of handling. These rings are bonded by
heat, snapped into place, glued, welded, etc.
4. Insulin Syringe: a piston syringe, typically sterile,
single-use with a needle, used for subcutaneous
injection of insulin.
5. Cartridge Syringe Holder: a piston syringe similar to
regular piston syringe except it is a reusable holder
for a prefilled cartridge with needle. If sold with a
drug cartridge the "kit" is regulated as a drug. If
sold with a biologic cartridge the "kit" is regulated
as a biologic.
6. Nozzle: the portion of the barrel of the syringe to
which a needle is attached. The types are as follows:
Luer-lock: secures the needle onto the syringe by
locking the needle hub onto the nozzle. The luer-
lock makes a stable connection between the syringe
and needle.
Slip Tip: secures the needle with only a
compression fitting of the needle hub to the
syringe nozzle.
Eccentric: provides a connection that is almost
flush with the side of the barrel.
7. Intended Use: the objective intent of the persons
legally responsible for the labeling of the device.
The intent is determined by their expressions or may be
shown by the circumstances surrounding the distribution
of the device. The objective intent may, for example,
be shown by labeling claims, advertising matter, or
oral or written statements by such representatives. It
may be shown by the offering or the using of the
device, with the knowledge of such persons or their
representatives, for a purpose for which it is neither
labeled nor advertised ( 801.4). Some use conditions
for syringes may include single use only, disposable,
reusable, short-term use, and home use.
8. Abbreviations:
AAMI - Association for the Advancement of Medical
Instrumentation
ANSI - American National Standards Institute
ASTM - American Society for Testing and Materials
CBER - Center for Biologics Evaluation and Research
CDER - Center for Drug Evaluation and Research
CDRH - Center for Devices and Radiological Health
CFR - Code of Federal Regulations
DSMA - Division of Small Manufacturers Assistance
FDA - Food and Drug Administration
FR - Federal Register
HIMA - Health Industry Manufacturers Association
ISO - International Organization for Standardization
OCS - Office of Compliance and Surveillance
ODE - Office of Device Evaluation
SMDA - Safe Medical Devices Act of 1990
D. General Principles Regarding Presentation of Data
1. Editorial Considerations: The 510(k) should be
carefully edited, as well as scientifically reviewed
before it is submitted to FDA. It should be proofread
to assure that all pages/sections are included and are
properly indicated, consecutive, distinctly copied, and
legible.
2. Abbreviations: Standard abbreviations acceptable to a
significant peer reviewed journal should be used
wherever possible. All other abbreviations should be
identified at the beginning of each section in which
they are used or in footnotes to tables and graphs.
3. Data Availability: This document outlines typical
circumstances of data review. It is not possible to
anticipate all situations that may require FDA review.
Thus, those submitting applications should be aware
that they may be asked to submit additional data, to
present data in another format or to provide more
detailed explanations of the information submitted, if
required to establish equivalence.
Applicants should keep data used for the 510(k)
submission on file in a controlled and well-organized
format. This will allow the applicant to expeditiously
supply FDA with additional information or analysis if
required. Errors in data that are identified by the
applicant after submission to FDA should be brought to
FDA's attention immediately.
4. Tables and Graphs: Well-constructed tables are
fundamental to the reporting and evaluation of data.
All tables should be clearly identified and captioned
with symbols keyed to a footnote or accessible
reference page that adequately indicates the nature of
the data.
Graphs should supplement, not replace, data tables.
They should be of a high quality.
5. Published Literature: Published methods or data
referenced in study reports should be made available to
FDA upon request. Reprints of other referenced
published reports or data should also be made available
to FDA upon request. All referenced reports and data
should be summarized including an explanation how it
relates to the current submission. Reference citations
should be complete (e.g., title, author, volume, year).
6. Protocols and Data Analysis:
Test reports must include the protocol (objectives,
precise description of materials, experimental methods,
controls), observations, statistical methods and
analyses, conclusions and comments. Do not submit raw
data. Additional specific directions on protocols are
included in sections that follow.
7. Reference to Submitted Data:
In support of the 510(k), the applicant may reference
any information previously submitted to FDA. If the
applicant did not submit the referenced data he must
provide, or have the submitter provide to FDA, a letter
of authorization. Often, if the data are not
extensive, resubmitting data in the 510(k) will
facilitate the review of the document.
E. Document Availability
The following documents are available from DSMA [(800)638-2041 or
(301)443-6597]:
Tripartite Biocompatibility Guidance for Medical Devices
ODE Blue Book Memorandum #K90-1: 510(k) Sterility Review Guidance
II. CONTENT AND ORGANIZATION OF INFORMATION IN A 510(K) FOR A
PISTON SYRINGE
A. Cover Letter
The submission shall have a signed cover letter providing the
following information described in 807.87 (Information required in a
premarket notification submission):
1. The piston syringe's trade or proprietary name.
2. Common Name: Piston Syringe, Insulin Syringe, etc.
3. Classification name: Piston Syringe
4. The establishment registration number, if applicable,
of the sponsor, owner or operator submitting the
premarket notification
5. Class: II
Panel: 80
Procodes: list all the following that apply
FMF - Piston Syringe
MEG - Antistick Syringe
FMI - Hypodermic Single Lumen Needle
6. A statement explaining the purpose of the submission
(e.g., new device, significant modification of device
previously found equivalent (new intended use,
material, or manufacturing process, etc.)). Refer to
807.87(g) for additional information regarding changes
to devices. The change may require some or all of the
information needed for a new device. Please supply the
previous 510(k) number(s), if applicable.
7. A brief statement indicating the device is similar to
and/or different from other products of comparable type
in commercial distribution.
8. Name, address, and phone number of a U.S. contact
person, if available.
B. Labels and Labeling
1. The submission shall contain proposed labels, labeling,
and advertisements sufficient to describe the device,
its intended use, and the directions for use. Labels
include the information affixed directly to the device
or its container or packaging. Labeling also includes
professional or patient package inserts, and any other
information that accompanies the device.
2. The labeling must meet the requirements of 21 CFR Part
801 as it relates to a determination of intended use.
ODE will concentrate on the following portions of Part
801:
Subpart A, 801.4 and 801.5, related to intended
uses and adequate directions for use; and
Subpart B, 801.109 and 801.116, related to
prescription devices and commonly known
directions.
Other provisions of Part 801 are deferred for review to
CDRH/OCS Device Labeling Compliance Branch.
3. Labeling for the piston syringe should include, if
applicable:
a. the identity of the device (type, size, needle
gauge and length, if applicable) and quantity;
b. the statements "sterile, single use only,
nonpyrogenic, nontoxic";
c. the prescription statement under 801.109(b)(1),
except for insulin syringes;
d. special requirements for insulin syringes as
described in 801.403 about mixing insulin,
including "For use with U100 insulin only" on the
barrel and gradations on the barrel in units;
e. any instructions for using specialized syringes
such as the anti-needlestick devices and cartridge
syringes;
f. any specific drug or biologic use; and
g. instructions on how to clean and sterilize any
reusable components.
C. Standards and Insulin Syringe Regulations
Listed are some, but not all, of the standards relating to piston
syringes, and the regulations relating to insulin syringes:
1. ISO 7886, Sterile Hypodermic Syringes for Single Use;
2. ISO 7864, Sterile Hypodermic Needles for Single Use;
3. ISO 594, Conical Fittings with a 6% (Luer) Taper for
Syringes, Needles, and Certain Other Medical Equipment;
4. ISO 9626, Stainless Steel Needle Tubing for Manufacture
of Medical Devices;
5. ISO 6009, Hypodermic Needles for Single Use - Colour
Coding for Identification;
6. ISO 8537, Sterile, Single-Use Syringes, with or without
Needle, for Insulin;
7. ANSI/HIMA Standard MD70 (Luer Taper Fittings for
Medical Material);
8. Military Standard MIL-S-36157 or later edition;
9. ASTM for stainless steel tubing testing.
10. 801.403 INSULIN SYRINGES
The applicant may certify that the device meets a standard.
The applicant then is obliged to comply with the standard
and maintain documentation of tests showing that the device
meets the standard. Certification of meeting a specific
standard and reference to standards in the 510(k) may reduce
the documentation needed in the 510(k) submission. This is
noted in pertinent sections.
D. Device Description
The applicant must submit a complete description of the device,
including all models and variations.
1. State the type(s) of syringe(s) (e.g., standard piston,
control, insulin, cartridge syringe). Provide a
labeled representation of the device in sufficient
detail to facilitate the evaluation of the nature and
operation of the device (e.g., photographs, detailed
drawings, or engineering drawings). If the labeling
already includes sufficient illustrations of the
device, please refer to the labeling.
2. Provide a clear description of the intended use(s) of
the syringe.
If the syringe is labeled for use with a specific drug
or biologic, the applicant must supply information
demonstrating that use of the drug/biologic with the
device is consistent with the approved drug/biologic
labeling.
3. Provide the specifications for the device. The
applicant may refer to relevant standards.
a. Physical Specifications
(1) Dimensions: length, diameter, tip type, and
volume.
Standard Piston Syringes: The syringe barrel
should be long enough for the user to fill the
syringe beyond the highest graduation mark without
risking contamination and leakage.
Insulin Sizes: The volumes for the standard
syringes are 1.0 ml (100 units), and 0.5 ml (50
units).
(2) Hypodermic Needle (if applicable): length, gauge,
and configuration of the tip.
(3) Nozzle: type (see definitions section),
dimensions.
(4) Markings: graduated scale, position of scale,
length of scale, numbering of scale, and
legibility criteria (for insulin syringes).
Insulin Syringes: The scale on the barrel should
be in units of insulin. The graduations should be
easily legible with the numbers as large as
possible. Insulin syringes should have markings
of a color that contrasts clearly with the syringe
and the legend "For use with U100 insulin only."
The ink or pigment should not rub off during use.
(5) Needle Covers (if applicable): dimensions and
color.
Needle covers for insulin syringes should be
color-coded orange for visually impaired users.
(6) Lubricant: identity, chemical composition,
amount/cm2 (syringe surface).
(7) Barrel: transparency.
(8) Accuracy: of delivery.
b. Mechanical Specifications
(1) Reuse Durability (for reusable piston syringes):
number of times the device can be sterilized and
still meet specifications (using sterilization
method indicated in the labeling).
(2) Needle Cover (if applicable): strength.
(3) Needle (if applicable): hub/needle bond strength.
c. Biological Specifications
According to the draft ISO 194 Biocompatibility
Standard, syringes are categorized as Externally
Communicating Devices, Blood Path Indirect,
Limited Exposure. Needles for syringes are
Externally Communicating, Circulating Blood,
Limited Exposure. The Tripartite Biocompatibility
Guidance has a related categorization.
d. Chemical Specifications
(1) State the compatibility conditions for the device
with any specific drug or biologic referenced in
the device labeling.
(2) State the stability conditions for storage of any
specific drug or biologic referenced in the device
labeling.
4. Provide a complete listing of all materials (chemical
formulations), particularly those with fluid or body
contact, used in fabricating the syringe, including the
plunger, barrel, plunger tip, and if applicable,
needle, hub, and needle cover.
Identify all colors (ink, dyes, markings, radiopaque
materials, etc.) used in manufacturing the device.
E. Descriptive Comparison to a Legally Marketed Device
Identify a legally marketed syringe to which substantial equivalence
is claimed. If possible, identify the 510(k) number(s). More than one
syringe can be listed, but the device(s) chosen should be as close in
intended use and technology to the new device as possible. Provide the
information noted below to show how the new device is both similar to and
different from the legally marketed device. Side by side comparisons,
whenever possible are desirable (see Attachment 1). This information may
be identical to that provided under Part C and the applicant may wish to
combine some or all of Parts C and D information. Indicate how any
differences may affect safety and effectiveness.
1. Provide labeling (labels, instructions for use,
promotional material) for the legally marketed
device(s) to which substantial equivalence is claimed.
To facilitate comparison, also include clear
representations of the legally marketed device(s),
unless the labeling has ample information.
2. Compare and contrast the intended use for the new
device to the predicate device(s).
3. Compare all materials used to fabricate the devices.
The precise materials of the new device, and if
possible, the predicate device(s) should be identified
to the extent possible.
4. Compare the operational principles including mode of
action.
5. Compare physical, mechanical, biological, and chemical
specifications.
F. Performance Data Supporting Substantial Equivalence
Provide the protocols and results of the tests indicated below. If
the stated test is taken from a standard that specifically addresses the
performance criterion, then the applicant should reference the standard and
certify that the device will meet the criterion. Data need not be
submitted in this instance.
The studies should be well-designed to meet the stated objectives.
This will include rigorous attention to: statistical elements (hypotheses,
test statistics, analyses, sample size and sampling, power, etc.),
inclusion/exclusion criteria, controls, minimization of bias, test
parameters (endpoints), follow-up, evaluation criteria, etc. Some of the
above points may overlap. Ample reference material exists on study design
and methods upon which the applicant may rely (e.g., biocompatibility).
1. Biocompatibility
Certify that the identical materials have been used in
other legally marketed devices used under the same use
conditions, or provide data documenting the
biocompatibility of the component materials in the
finished product according to the 1987 Tripartite
Biocompatibility Guidance for Medical Devices and 1992
draft ISO 194 standard (Biological testing of medical
and dental materials and devices). The test category
of piston syringes and needles in the ISO standard are
specified in Section D.3.(c) above. With regard to
metals, if the applicant certifies that a component
metal meets an ASTM standard where biocompatibility is
indicated, e.g., ASTM 316 stainless steel, the
certification will suffice for documentation purposes.
Biocompatibility test data may be required for colors
that are not listed in FDA regulations or are not used
in other legally marketed devices for a similar
intended use.
2. Comparative Claims
Additional data may be needed to support comparative
claims.
3. Unique Designs
Additional data may be needed to support designs that
are significantly different from typical designs.
4. Drug/Biologic and Device Compatibility
Data demonstrating drug or biologic and material
compatibility is required if a specific drug or
biologic is referenced in the device labeling.
5. Drug/Biologic Stability
If the device labeling indicates that the drug or
biologic is to be stored in the syringe, stability data
for the recommended storage period and conditions is
required.
Any compatibility and stability data will be referred to
CDER or CBER for their consult review.
G. Sterilization Information
See Attachment 2
H. SMDA Information
All persons submitting a 510(k) must include either a summary of
safety and effectiveness information in the 510(k) upon which an
equivalence determination could be based OR a statement that safety and
effectiveness information about the [device name] will be made available to
any interested person upon request. Safety and effectiveness information
refers to adverse safety and effectiveness information, descriptive
information about the new and predicate devices, and performance/clinical
testing information.
If the summary option is selected, it should be included on a separate
page and identified as the Summary of Safety and Effectiveness for [device
name].
If the statement option is selected, do not include the word "summary"
in the statement.
The content and format of this information is specified in 57FR No.
82, Tuesday, April 28, 1992, page 18062.
I. Sample
Provide a sample, if possible.
J. Anti-needlestick Requirements
If the piston syringe incorporates an anti-needlestick mechanism, the
applicant must completely describe the mechanism, demonstrate the
equivalence of the mechanism, and substantiate all labeling claims
associated with the anti-needlestick feature.
CDRH is currently writing a guidance document on the content of
510(k)s for devices incorporating antistick features and for stand-alone
antistick devices. This document will be available from DSMA when
finalized.
III. PREMARKET NOTIFICATIONS FOR KITS
1. See Attachment 3 for required information.
2. The following kit components require further evaluation
by FDA and/or require language in an equivalence letter
noting special requirements or limitations for these
components:
Sutures
Dressings
Medical Gloves
Drugs
Biologics
IV. COMMENTS
Address any comments regarding this guidance to:
Chief, General Hospital Devices Branch
HFZ-412
1390 Piccard Drive
Rockville, MD 20850-4308
Attachments
ATTACHMENT 1
EXAMPLE OF SIDE BY SIDE COMPARISON TABLE
ELEMENT OF COMPARISON |
SUBJECT DEVICE |
CLAIMED SE DEVICE #1 |
(CLAIMED SE DEVICE #2) |
| syringe type | |||
| intended use(s) | |||
| principle of operation | |||
| specific drug use | |||
| length | |||
| diameter | |||
| tip type | |||
| volume | |||
| needle length | |||
| needle gauge | |||
| needle tip configuration | |||
| nozzle type | |||
| barrel marking specs | |||
| gradations legibility | |||
| needle cover dimensions | |||
| needle cover color | |||
| lubricant composition | |||
| lubricant amount/cm2 | |||
| barrel transparency | |||
| delivery accuracy | |||
| reuse durability | |||
| needle cover strength | |||
| hub/needle bond strength | |||
| biocompatibility | |||
| materials | |||
| labeling | |||
| other |
SE=substantially equivalent, specs=specifications
The applicant may reference relevant standards in the Table.
ATTACHMENT 2
STERILITY INFORMATION
For a device sold sterile, provide the following information as
detailed in the ODE Blue Book Memorandum #K90-1.
1. Sterilization method that will be used.
2. A description of the method that will be used to
validate the sterilization cycle, but not the
validation data itself. Reference to a standard method
(e.g., AAMI Radiation Standard) usually is sufficient.
3. The sterility assurance level (SAL) for the device
which the firm intends to meet. An SAL of 10-6 is
required for devices which contact normally sterile
areas of the body.
4. A description of the packaging to maintain the device's
sterility (this is not to include packaging integrity
testing data).
5. If sterilization involves EtO, the maximum levels of
residues of ethylene oxide, ethylene chlorohydrin, and
ethylene glycol which remain on the device. The levels
should be consistent with the draft Federal Register
Notice on EtO limits.1
6. Whether the product is "pyrogen free" and an
identification of the method used to make that
determination.2
7. The radiation dose, if radiation sterilization will be
used, and if it has been determined. Otherwise, amend
the 510(k) file at FDA when the dose has been
determined.
References
1. FDA Proposed Rule, 43 FR 27482 (June 23, 1978), Maximum
Residue Limits for Ethylene Oxide, Ethylene Chlorohydin, and
Ethylene Glycol.
2. FDA Guidelines on Validation of the Limulus Amebocyte Lysate
(LAL) Test as an End-Product Endotoxin Test for Human and
Animal Parenteral Drugs, Biological Products, and Medical
Devices.
ATTACHMENT 3
KIT INFORMATION
The applicant must provide the following for a kit, i.e., a
package consisting of at least one medical device and additional
devices, drugs, or biologics as other components.
1. Include a complete and specific listing of all components of
the kit(s).
2. Certifications:
(a) I certify that the medical device components of my kit
listed on page(s) [SUBMITTER PROVIDE PAGE NUMBERS] are
either (1) legally marketed preamendments devices, (2)
exempt from premarket notification (consistent with the
exemption criteria described in the classification
regulations and the limitations of exemptions from
Section 510(k) of the act (e.g., 21 CFR 862.9), or (3)
have been found to be substantially equivalent through
the premarket notification process for the use(s) for
which the kit is intended (i.e., not claiming or
causing a new use for the component(s)).
(b) I further certify that I purchase the device components
in finished form, i.e., they are packaged, labeled,
etc., consistent with their preamendments, exemption,
or premarket notification criteria and status. All
purchased drug or biologic components are also packaged
and labeled consistent with their approval or
licensing.
If you cannot make certification statement (a) for each
device component of your kit, you must itemize the
components without preamendments, exemption, or premarket
notification status. You must also supply adequate
information so that FDA can evaluate the equivalence of
these components of your kit. This information may be the
same information needed for a separate 510(k) for each
component.
If you cannot make certification statement (b), then
identify the components purchased in unfinished form, e.g.,
packaged in bulk (not final packaged and labeled in separate
units).
3. Clearly identify in the list of kit components any that are
drugs and biologics. For example, state next to the item
that it is a drug or a biologic.
4. Describe how the kit is assembled and processed into
finished form for purchase (e.g., the components are taken
out of the finished product or bulk packaging, component X
is individually sterilized, all the components are then
placed on a tray, the kit is wrapped, but not sterilized
prior to shipment).
If there is any repackaging or reprocessing of a separate
component, then you must provide details on the repackaging
or processing and an analysis of the effect on the
component. This may require testing. For example, for
(re)sterilized devices conduct a validation study and
provide data in accordance with the ODE Sterility Blue Book
Memorandum. The processing of the final kit is also
important. You must evaluate whether the final processing
for the kit as a whole affects the safety or effectiveness
of any of the kit components.
5. The 510(k) should include all labels and labeling for the
kit. A kit label alone may suffice for all components only
if the label consolidates the required information typically
found in labeling for each individual kit component when
sold separately in final form. A component may require
specific labeling, such as a package insert, when adequate
directions for use (precautions, warnings, etc.) are
required. It is important to examine the labeling for the
individual components sold separately versus the labeling
provided for the kit. Verify that the labeling is adequate
or enclose additional labeling in the kit, as needed.
6. The items above identify labeling and processing issues
which may affect the regulatory status, or safety and
effectiveness of the kit. If you are aware of any other
factor which may impact upon the status of your kit, then
please bring it to our attention so that we may consider it
in our evaluation.
ATTACHMENT 4
PISTON SYRINGE REVIEW CHECKLIST
510(k)#: _______________ Sponsor: ___________________________________
Date: ___________________ Reviewer: __________________________________
ELEMENT ADEQUATE COMMENTS (e.g., N/A, page #, 30ml,
YES NO 18g, PVC, EtO, 10-6, ¾")
Cover Letter
trade name
common name
classification name
establishment reg. #
procode(s)
purpose of submission
previous files referenced
statement that device is similar to and/or different from other products
Labeling
identifies device
type
size
needle gauge
needle length
quantity
statements
sterile
single use only
nonpyrogenic
nontoxic
Rx
insulin syringes meets §801.403
specialized instructions
specific drug/biologic use
reuse instructions
Description of Device
type
basic description
photograph/drawing
Intended Use(s)
clear statement
any specific drug/biologic support information
Physical Specifications
length
diameter
tip type
volume
needle length
needle gauge
needle tip configuration
type of nozzle
description of markings
legibility criteria
needle cover dimensions
needle cover color
lubricant identity
lubricant composition
lubricant amount/cm2
barrel transparency requirements
delivery accuracy
Mechanical Specifications
reuse durability
needle cover strength
hub/needle bond strength
Biological Specifications
biocompatibility require- ments for all components and materials
Chemical Specifications
compatibility requirements specific drug/biologic
stability requirements drug/biologic storage
Materials Identification
plunger
barrel
plunger tip
hub
needle
needle cover
any colors used in mfg.
Descriptive Comparison to Legally Marketed Device
identified appropriate legally marketed device(s)
labeling
description
intended use(s)
materials
mode of operation
physical specifications
mechanical specifications
biological specifications
chemical specifications
side by side comparison
discussion of how differences may affect safety and effectiveness
Performance Data Supporting Equivalence
biocompatibility
comparative claim(s)
unique design
drug/biologic-material compatibility
stability - storage
Sterilization Information
method
validation method
SAL
packaging description
EtO residuals
pyrogen free method
radiation dose
SMDA Information
summary
statement
Sample
provided
Kit Information
list of components
certification statements
any drugs and/or biologics
any sutures, dressings, gloves
description of assembly and processing
kit label/labeling
Antistick Feature If yes, see additional review
ADDITIONAL REMARKS:
Updated September 5, 1997
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