Sterilized Convenience Kits for 
Clinical and Surgical Use;  
 
Final Guidance for Industry 
 
 
 
 
 
 
 
 
 
Document issued on: January 7, 2002 
 
 
 
This document does not supersede any previous document. 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department Of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
 
Office of Compliance  Preface 
 
 
Public Comment 
 
Comments and suggestions may be submitted at any time for Agency consideration to Dockets 
Management Branch, Division of Management Systems and Policy, Office of Human Resources 
and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, 
(HFA-305), Rockville, MD, 20852.  When submitting comments, please refer to the exact title of 
this guidance document.  Comments may not be acted upon by the Agency until the document is 
next revised or updated. 
 
For questions regarding the use or interpretation of this guidance for medical devices, contact Wally 
A. Pellerite in the Office of Compliance, Center for Devices and Radiolog ical Health at (301) 594-
4692 or email WAP@cdrh.fda.gov. 
 
For questions regarding prescription drug products, call the Division of Prescription Drug 
Compliance and Surveillance, in the Center for Drug Evaluation and R esearch (CDER) at (301) 
594-0101.  For questions regarding over the counter drugs, call the Division of Labeling & 
Nonprescription Drug Compliance, in CDER, at (301) 594-0063.  For questions regarding 
manufacturing and quality control, call the Division of Manufacturing and Product Quality at (301) 
796-3191.
   
 
 
Additional Copies 
 
Additional copies are available from the Internet at: 
http://www.fda.gov/cdrh/comp/guidance/1390.pdf  , or CDRH Facts-On-Demand.  In 
order to receive this document via your fax machine, call the CDRH Facts -On-Demand 
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone.  Press 1 to enter 
the system.  At the second voice prompt, press 1 to order a document.  Enter the document 
number 1390 followed by the pound sign (#).  Follow the remaining voice prompts to 
complete your request. 
  2 Sterilized Convenience Kits for Clinical 
and Surgical Use.  
 
 
 
 
This document is intended to provide guidance.  It represents the Agencys current 
thinking on this topic.  It does not create or confer any rights for or on any person 
and does not operate to bind the Food and Drug Administration (FDA) or the 
public.  An alternative approach may be used if such approach satisfies the 
requirements of the applicable statute and regulations. 
 
 
 
 
The Least Burdensome Approach 
 
We believe we should consider the least burdensome approach in all areas of medical device 
regulation.  This guidance reflects our careful review of the relevant scientific and legal 
requirements and what we believe is the least burdensome way for you to comply with those 
requirements.  However, if you believe that the information requested in the guidance is not 
relevant to the decision-making process or that an alternative approach would be less 
burdensome, please contact us so we can consider your point of view.  You may send your 
written comments to the contact person listed in the preface to this guidance or to the CDRH 
Ombudsman.  Comprehensive information on CDRH's Ombudsman, including ways t o contact 
him, can be found on the Internet at http://www.fda.gov/cdrh/resolvingdisputes/ombudsman.html. 
 
 
 
Medical Device Kit Assembler / Manufacturer1 
 
The Center for Devices and Radiological Health (CDRH) continues to have concerns about 
finished device components that are assembled into clinical or surgical convenience kits and the kit 
is then sterilized.  In some cases, the finished device is actually being sterilized for a second time.  
Some components may be adversely affected by further processing in the sterilization process. For 
the purposes of this guidance, a finished device component in a convenience kit is a device in 
finished form held for sale to an end user that is suitable for use or capable of functioning, whether 
                                                                 
1 For concerns regarding drug products, please review the last paragraph of this document and 
contact the appropriate office in the Center for Drug Evaluation and Research.   
 
  or not it is packaged, labeled or sterilized.  Please ensure that your sterilization process does not 
adversely affect the finished components in your kits.     
 
There are five areas that, at a minimum, you should cover to ensure that the sterilization process 
does not adversely affect the finished components in your convenience kits. Those areas include 
the following:   
 
 -- Sterilization Proces s
 - Sterilant Residuals 
- Labeling 
- Premarket Notification 
- General Controls 
 
A sterilization process may pose the following issues that you need to  address: 
 
1.  Effects of the sterilization process -  
-   Does exposure to heat during the sterilization process cause the material in a 
device to degrade before the labeled expiration date? 
 
-   Does the sterilization process (e.g., vacuum effects, radiation) affect  the form, fit 
or function of device components?  The device kit repackers should ensure that 
the sterilization process does not adversely affect the functionality of the device 
components.  For example, it is known that irradiation can effect certain polym ers, 
resulting in a loss of strength. The device component manufacturer would have 
information or recommendations on the effects of the sterilization processes.   
 
-   Does the sterilization process affect the package integrity for devices?  For 
example, the package integrity of all device components should remain in tact for 
any sterilization cycle that may be designated for the convenience kits.  
 
2.  Labeling - 
 
-   The convenience kit should provide instructions for appropriate storage conditions 
and contain an expiration date supported by stability data. The expiration dates for 
device components should be revised based on data from your process validation 
studies for devices.  The expiration date should not be longer than the shortest 
expiration date of any component in the kit. 
  
For example, what is the impact on a kit's components when stored for one year 
at room temperature at 30 degrees centigrade?  (See ICH, Q1A Stability Testing 
of New Substances and Products.) If you determine that the shortest expiration 
date is 3 months from the date of sterilization, that establishes the sterility 
expiration date for the entire kit. 
  
  2 -   There is no specific policy in place with respect to labeling for device kits.   
 
 
3.  Premarket Notification - 
 
-   Is a 510(k) or PMA needed for the kit? 
   
As a manufacturer of convenience kits, you should determine whether the 
sterilization of the convenience kit significantly affects the safety or effectiveness of 
any of the kit's components.  If your sterilization process looks like it significa ntly 
affects the safety or effectiveness of any of the kit's medical device components, 
you may need to submit a premarket notification to our Office of Device 
Evaluation (ODE) in the Center for Devices and Radiological Health.  
 
In making this determination, we recommend that you review the interim guidance 
for convenience kits entitled: 
 
"Convenience Kits Interim Regulatory Guidance," issued by ODE.   
The guidance can be accessed on the Internet at 
http://www.fda.gov/cdrh/ode/convkit.html.   
 
You may also need to review the procedures described in related guidance 
document entitled: 
 
"Deciding When to Submit a 510(k) for Change to an Existing Device," 
which may be accessed on the Internet at 
http://www.fda.gov/cdrh/ode/510kmod.html 
 
 
Part of our premarket review of convenience kits focuses on the impact that 
sterilization has on individual kit components.  This guidance is intended to help 
you address questions that can ensure that the components are not adversely 
affected by the reprocessing procedures and that the kit can be used for its 
labeled indications.  
 
4.  General Controls -  
 
-   You are required to comply with general controls, such as manuf acturing, 
labeling controls, and postmarket reporting of adverse events or any 
corrections and removals of product that present a risk to health. Because the 
assembly and sterilization of your convenience kit is considered a 
manufacturing operation subject to good manufacturing practice requirements, 
it is necessary for you to document that the device components are not 
adversely affected by further processing and that the labeling is correct.  You 
  3 should be sure that expiration dates on labeling are valid.   (See Title 21 Code 
of Federal Regulations (CFR) Part 820 for Good Manufacturing Practices 
(GMPs).)  The agency may review those records. 
 
Additional information regarding manufacturing regulations that apply to the 
sterilization of medical devices is available in the document entitled 
"Application of the Device Good Manufacturing Practice Regulation to the 
Manufacture of Sterile Devices."  The document can be accessed on FDA's 
Internet site at: http://www.fda.gov/cdrh/ode/267.pdf.  In order to receive this 
guidance via a fax machine, call the CDRH Facts-on-Demand (FOD) system 
at (800) 899-0381 or (301) 827-0111 from a touch-tone telephone.  At the 
first voice prompt press 1 to access the FOD option, at the second voice 
prompt press 2, and then enter the document number 267 followed by the 
pound sign.  Then follow the remaining voice prompts to complete your 
request.   
 
 
 
In summary, you should address the following issues related to the manufacture of your 
convenience kits:   
 
1.  How does your sterilization process affect the various device components in your 
kit? 
2.  What are the sterilant residuals of your sterilization process? 
3.  Does the labeling of the kit include validated storage instructions?  
-  Is the expiration dating for the kits appropriate? 
4.  Is a 510(k) or PMA submission needed? 
5.  Do you meet the general manufacturing, labeling, and postmarket reporting 
requirements, i.e., adverse events and recalls (corrections and removals for 
devices (21 Code of Federal Regulations Parts 820, 803 and 806.))? 
 
For questions regarding medical devices incorporated into convenience kits and their labeling 
requirements, please contact Wally A. Pellerite in the Center for Devices and Radiological Health, 
Office of Compliance at (301) 594-4692. 
 
Drug Questions:  
 
Contact the Center for Drug Evaluation and Research (CDER) for questions about drug products 
that concern labeling, new drug issues, listing and registration requirements, CGMPs, or other 
regulatory requirements for drugs used in convenience kits.   
 
Prescription drugs (Rx) questions or issues should be directed to the Division of Prescription Drug 
Compliance and Surveillance, HFD-330 at (301) 594-0101.   
 
  4 Over the counter drug products questions or issues should be directed t o the Division of Labeling 
& Nonprescription Drug Compliance, HFD-310 at (301) 594-0063.   
 
Current Good Manufacturing Practice (CGMP) requirement issues or questions applicable to drug 
products in convenience kits, should be directed to the Division of Ma nufacturing and Product 
Quality at (301) 594-0093.   
 
You may also access CDER's Internet site at 
http://www.fda.gov/cder/directories/reference_guide.htm for information on the offices and/or 
review divisions that could be contacted about the specific drug products intended for use in the 
sterilized kit.  
 
            Sincerely yours, 
 
             
            Larry D. Spears 
Acting Director 
            Office of Compliance 
            Center for Devices and 
              Radiological Health 
  5