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 up dated in the next revision to include the standard elemnt s of GGP 's .  GUIDANCE ON THE 
CONTENT AND FORMAT OF 
PREMARKET NOTIFICATION [510(k)] SUBMISSIONS 
FOR SHARPS CONTAINERS 
October 1993 
Food and Drug Administration 
Center for Devices and Radiological Health 
office of ~eviceE valuation 
Division of General and Restorative Devices 
Infection Control Devices Branch  A.  Scope 
This document pertains to sharps containers and secondary 
sharps containers.  A secondary container holds the sharps 
container, if leakage is possible (refer to OSHA regulation 
. 
29 CFR 1910.1030 (d)( 4)( iii)( A)( 3))  
B.  Introductory Information 
1.  The labeling or promotional material for the sharps 
container may not state that the device is FDA approved 
or cleared.  The applicant may be able to claim the 
device meets OSHA rfgulations on Bloodborne Pathogens, 
29 CFR 1910.1030, if such a statement is permitted 
under OSHA regulations and statutes. 
2.  FDA 510(k) clearance does not preclude OSHA from 
finding the device and/or its use to be violative under 
OSHA regulations.  If the design is found deficient by 
OSHA, subsequent to a finding of substantial 
equivalence by FDA, and it is modified to render it 
acceptable to OSHA, then a new 510(k) should be 
submitted noting the modifications. 
3.  FDA and OSHA are working together to implement adequate 
infection control practices to reduce the risk of 
bloodborne infections.  FDA is not enforcing the OSHA 
regulations, per se.  Rather, FDA evaluates whether a 
sharps container has features that are consistent with 
current good infection control practices, for instance, 
as expressed in the OSHA Bloodborne Pathogen 
regulations related to engineering and work practice 
controls.  OSHA engineering controls are controls that 
isolate or remove the bloodborne pathogens from the 
workplace.  OSHA work practice controls are intended to 
help ensure that sharps containers are used in a manner 
that will reduce the likelihood of an exposure to 
infectious material by altering the manner in which 
sharps disposal is performed (e.g.,  recapping 
contaminated sharps only when no alternative is 
feasible or when such action is required by a specific 
medical procedure, placement of containers, and routine 
. 
replacement) 
4.  This document is fashioned in a checklist format for 
use by FDA reviewers, and it is also a guide for 
applicants.  In the blank spaces next to the requested 
information the FDA reviewer should indicate  when 
"YUl 
the information is acceptable, "NW when not acceptable, 
and "NAW when not applicable.  Applicants may wish to 
reproduce portions of the guidance and include it in  the 510(k) application, with supporting information, to 
facilitate the review process. 
5.  The applicant should respond to each of the items in 
the guidance.  Provide the information requested, state 
why the information is not applicable, or provide 
alternative information that is commensurate with the 
data requested. 
6.  Be advised that FDA has determined that devices which 
remove sharps off the needle hub, typically by means of 
an electrical charge or heat, present a new type of 
safety and effectiveness issue (potential for toxic 
emissions), and are therefore not substantially 
equivalent devices.  The devices are Class I11 products 
requiring premarket approval, or reclassification to 
Class I or I1 before they may be marketed. 
C.  Standards 
There are no FDA regulatory standards for sharps containers. 
The applicant may choose to indicate that the device meets a 
standard.  The following are examples of standards and 
reference information that are relevant to sharps 
containers: 
- 
Occupational Safety and Health Administration 
Occupational Exposure to Bloodborne Pathogens; final 
rule (29 CFR 1910.1030; Federal Register 1991 December 
6; 56, No. 235:64175-82. 
- 
British Standard Institution  Specification for Sharps 
Containers (BS 7320:1990) 
- 
Australia Standard  Non-Reusable Containers for the 
Collection of Sharps Medical Items Used in Health Care 
- 
Areas (AS 4031  1992, 1992) 
- 
American Society for Testing and Materials (ASTM) 
Standard for puncture resistance being considered (ASTM 
Task Force F04.65.01) 
Canadian Standard being considered (CAN/CSA 2316.6) 
Health Devices, August-September 1993, ECRI, Vol. 22 
Nos. 8-9.  D.  Cover  Letter 
State at the top of the cover letter "510(k) NotificationI1 
1.  Trade/Proprietary Name (Model Name and 
Number) : 
2.  Common/Usual Name:Sharps container and/or secondary 
container should be noted, as applicable. 
3.  Classification name (select one): 
accessory to hypodermic needle 
accessory to blood collection device (if dedicated 
to that use) 
other: describe 
4.  Reason for Submission 
new device 
modified device 
other: describe 
5.  Classification: Class I1 for accessories noted in item 
3 above. 
6.  Panel/Procode: 80 F'MI  for a needle accessory 
Registration #: 
E.  Labeling 
Provide copies of labels, labeling, and promotional 
material.  All claims will be closely scrutinized for 
supportive information (e.g:, disease prevention claims, 
comparative performance clalms). 
Biohazard labels with visible location on device 
General Labeling Information required under 21 CFR 
801 (e.g., manufacturers name and address) 
Disposal Procedures 
Assembly/Mounting Instructions 
Operating Instructions  F.  General Description 
Provide a detailed description of the sharps container. 
Pictures or detailed drawings (labeling may suffice) 
Volume 
Dimensions 
Empty Weight 
Describe the materials and form of construction 
Description of Materials (type of plastic, metal, 
cardboard, etc) 
Thickness of Materials (provide variations in 
thickness that may exist in different parts of 
device, and tolerances) 
How Device is Formed (molded, glued edges, etc.) 
Reusable (labeling and design must address safe 
disposal of sharps per OSHA regulations, i.e.,  no 
manual processing) 
Clarity of Material (clear, opaque, etc.) 
Intended Location for Use (OR, patient room, etc.) 
Describe any unique features in detail. 
G.  Design Features of Containers for Contaminated Sharps 
Indicate if the device meets the following design features, 
when applicable.  The basis for the list is the OSHA 
regulations. 
1.  Closable 
2.  Puncture resistant 
3.  Leakproof on the sides and bottom 
4.  Labeled or color-coded: 
a.  BIOHAZARD warning label 
fluorescent orange or orange-red or predominantly  so, with lettering or symbols in a contrasting 
color 
b.  affixed as close as possible to the container by 
string, wire, adhesive, or other method that 
prevents loss or unintentional removal 
c.  red container may substitute for labels 
Capable of maintaining stable, upright position 
No feature to bend, break, or shear needle (includes 
blunting and melting of needle). 
OSHA Compliance Directive On Needle Unwinders 
Feature to recap the needle, or remove the needle off 
the hub of the syringe ( e , a n unwinder as 
characterized by OSHA) provides for a one-handed 
technique (i.e. does not require holding container with 
. 
the free hand) 
Container with unwinder is designed so that it is 
stabile (secured to a wall, table, or tray) to prevent 
slipping during use. 
The unwinder is designed to provide for a secure 
capture. 
Container for reusable sharps shall not be designed to 
require employee to reach by hand into the container to 
retrieve the contaminated reusable sharps. 
Container is designed to easily and safely determine if 
the container is full. 
Optional features/accessories: 
- locked enclosure 
holder to secure to wall, table, etc. 
H.  Design Features of Secondary Containers 
Indicate if the device meets the following design features, 
when applicable.  The basis for the list is the OSHA 
regulations. 
1.  Closable  2.  Constructed to contain all contents and prevent leakage 
during handling, storage, transport, or shipping 
3.  Labeled or color-coded as above in G.4. 
I.  specifications of Design Features 
State the specifications for each of the following features. 
The specification should be objective and quantitative, when 
appropriate (e.g.!  puncture resistance).  Refer to any 
standard the specification meets. 
Impact Resistance 
Puncture Resistance (base, sides, closure, top) 
Overfill Detection 
Leak Resistance (sides and bottom) 
Sharps Access and Closure 
Stability (maintaining upright position) 
Mounting Accessories and any Locking Mechanism 
Handling (safe transportation features) 
Capacity 
Feature to Minimize Aerosolization 
OTHER (as applicable, e.g.,  electrical): 
J.  Design Validation Test Methods 
Summarize the test methods for each of the specifications 
noted in item I above.  The protocol must indicate pass-fail 
criteria and the safety and effectiveness basis for the 
criteria (e.g., a standard).  There are tests methods 
indicated in the referenced standards. 
K.  Comparison to a Legally Marketed Sharps Container 
Persons submitting 510(k)s must compare their device to a 
legally marketed device.  FDA has recently decided to 
actively regulate sharps containers.  FDA formal 
announcement of this initiative is imminent and it may 
provide a grace period for submission of 510(k)s.  There will be a period of time during this transition in 
regulatory control where some currently marketed containers 
are still pending FDA clearance, making confirmation of 
legality of a predicate device problematic in the short 
term.  Still, the applicant should provide a comparison of 
their device to ones available on the market and to 
available standards noted in item C above. 
Provide a side by side comparison of design features and 
specifications of containers that most closely match the 
device being submitted for clearance. 
L.  Safe Medical Devices Act 510(k) Statement of Safety and 
Effectiveness or 510(k) Summary of Safety and Effectiveness 
Provide either the statement or summary as required under 21 
CFR 807.92 or 807.93 (see attached). 
M.  Address 
Submit duplicate copies (two copies) to the following 
address : 
FDA 
Document Mail Center 
HFZ-401 
1390 Piccard Dr. 
Rockville, MD  20850 
N.  Contact for Questions 
If there are any questions, please call: 
Branch Chief 
Infection Control Devices Branch 
(301) 594-1307 
0.  Attachment 
- 
21 CFR 807.87  807.94.