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 .  DEPARTMENT OF HEALTH & HUMAN SERVICES  Public Health Secvice 
Food and Drug Administration 
Center for Devices and 
Radiological Health 
FEB  3 1994  2098 Gaither Road 
Rockville MD 20850 
TO:MANUFACTURERS  AND INITIAL DISTRIBUTORS OF SHARPS CONTAINERS 
AND DESTROYERS USED BY HEALTH CARE PROFESSIONALS: 
The purpose of this letter is to clarify the regulatory status of 
devices which serve as Sharps Containers and/or Sharps Destroyers 
(sharps devices).  These products are devices as that term is 
defined by Section 201(h)  of the Federal Food, Drug, and C~smetic 
Act (the Act).  In the past, FDA has exercised enforcement 
discretion, and has not actively enforced marketing clearance, 
registration and listing, and manufacturing requirements for 
these devices.  This document shall serve to clarify all past 
correspondence and outline all requirements which=need to be 
complied with to lawfully market these devices. 
Because of increasing concern about transmission of disease 
associated with needle sticks, e.g.,  HIV, Hepatitis B, and other 
blood born agents, we are exercising our discretion to now 
require manufacturers and initial distributors of sharps devices 
to comply with all applicable requirements of the Act, including 
registration and listing, obtaining appropriate marketing 
clearance, assuring conformance with the Good Manufacturing 
Practices for medical devices regulation (GMP), and to 
appropriately label the devices to assure they provide adequate 
directions for safe use. 
If your firm introduced sharps devices into commercial 
distribution for the first time after May 28, 1976, the date of 
enactment of the device amendments to the Act, or if your firm 
has significantly modified any device which was commercially 
marketed prior to that date, you must submit a premarket 
notification [510(k)J, pursuant to the requirements of 21 CFR 
807.81(a) (1). 
If the type of sharp,s device submitted in your 510(k) submission 
is found to be not substantially equivalent (NSE) to a predicate 
device, your device will automatically be classified in Class 
111, in accordance with the requirements of section 513(f) of the 
Act, thereby requiring the submission of an application for 
premarket approval (PMA).  PMA submissions are based on the 
collection and review of preclincial, clinical, and where 
appropriate, engineering data collected in accordance with the 
Investigational Device Exemption (IDE) requirements to establish 
the safety and efficacy of the device being reviewed.  - 
Page 2  Manufacturers and Initial Distributors of Sharps 
Containers and Destroyers 
Sharps devices shall be labeled with an appropriately colored 
biohazard warning label, or be red in color and appropriately 
labeled with a biohazard warning.  In addition, these devices 
should be designed so that they are closable, puncture resistant, 
and leak proof on their sides and bottom. 
FDA is allowing manufacturers and initial importers a 
discretionary period to continue marketing sharps devices which 
are already in commercial distribution, providing the following 
requirements are fulfilled.  Within 180 days of the date of this 
letter, manufacturers and initial distributors of currently 
marketed sharps devices are to file appropriate premarket 
notification submissions with the Agency for each different type 
of device currently being marketed.  Firms will also be required 
to register their firms and list the products being manufactured 
and/or distributed in accordance with Sections 510(b) and/or (c), 
and (j) of the Act respectively.  Although encouraged to do so, 
foreign firms are not required to register with FDA, however, 
they are required to list their devices.  During this 180 day 
period, manufacturers and initial distributors should review all 
current labels and labeling for the sharps devices in 
distribution to assure they provide adequate directions for safe 
use, as described above.  All necessary labeling modifications 
should be made as soon as possible, and certainly within the 180 
day timeframe.  Firms should also assure the integrity of the 
devices being marketed to assure they are puncture resistant and 
do not leak.  Appropriate procedures and controls should be in 
place as required by the GMP to assure the consistent manufacture 
of quality devices. 
Firms which have complied with the provisions outlined above will 
be able to continue marketing their devices until FDA determines 
whether or not their device(s) are substantially equivalent to a 
predicate device. Those found "substantially equivalent (SE)" may 
continue to be lawfully marketed. 
Should FDA render a "not substantially equivalent (NSE)" 
decision, to your 510(k) submission, an approved application for 
premarket approval (P.MA)  will be required before you may legally 
continue to market your device.  In that instance, current 
marketing of your device must stop.  Firms choosing to 
"investigate" the use of their device as a means to collect data 
to establish the safety and efficacy of their device may do so 
under an Investigational Device Exemption (IDE), and label their 
devices appropriately. 
Sharps devices in commercial distribution before May 28, 1976, 
which have not been changed significantly (see 21CFR 807.81),  and  - 
Page 3  Manufacturers and Initial Distributors of Sharps 
Containers and Destroyers 
satisfy the labeling, registration and listing requirements, and 
are manufactured in accordance with the GMP, may continue to be 
marketed without submission of a 510(k). 
Failure to comply with the requirements of this letter in the 
timeframe specified may result in the distribution of violative 
devices. 
Devices not yet being marketed must comply with these 
requirements now.  New, additional models of devices should not 
be introduced into the marketplace without obtaining premarket 
clearance prior to their introduction into interstate commerce. 
Such devices will be considered misbranded and adulterated in 
accordance with Sections 502(0) and 501(f)(l)(B) accordingly. 
You may obtain a free booklet on how to prepare a premarket 
notification submission [510(k)J by calling our Division of Small 
Manufacturers Assistance at 1-800-638-2041. 
Should you have any questions regarding this policy or the 
contents of this letter, please contact Mr. Tim Wells, Acting 
Branch Chief, Gastro/Urology and General Hospital Devices Branch 
at this address, or you may call him at (301) 594-4616. 
Thank you for your cooperation. 
Sincerely yours, 
T9 
&  d 
Ronald  Johnson 
/J  -  Director 
- 
Office of Compliance 
Center for Devices and 
Radiological Health