Letter to Hospitals Re: Changes in Enforcement of FDA's Requirements on Reprocessing of Single-Use Devices

(You are encouraged to copy and distribute this information)                                                          

September 25, 2001

Dear Hospital Administrator and Hospital Risk Manager:

The purpose of this letter is to alert you to a change in FDA's policy on the reuse of single-use devices (SUDs) that will affect all hospital SUD reprocessors.  Specifically, FDA is extending the deadline for active enforcement to August 14, 2002, for the following postmarket requirements: medical device reporting, tracking, corrections and removals, quality system, and labeling.   

FDA's schedule for enforcement of other requirements remains unchanged.  As previously announced, FDA plans to begin inspecting hospital SUD reprocessors shortly.  FDA will immediately enforce the requirements for establishment registration and device listing.  FDA is actively phasing-in enforcement of its premarket requirements (as described below).

Change in enforcement approach to hospital SUD reprocessors

Beginning this fall, FDA intends to inspect hospital SUD reprocessors.  These inspections will cover all three classes (I, II, and III) of medical devices.  The change in FDA's reuse policy concerns the focus and possible outcomes of these inspections.  The focus will be to assess hospitals' compliance with the Agency's postmarket regulatory requirements.  However, the Agency does not intend to take enforcement actions against hospitals if they are found not to be in compliance with these requirements.  Rather, FDA plans to spend the next year educating hospitals on complying with the postmarket requirements.  This policy will remain in effect until August 14, 2002, provided that the hospitals are taking steps to correct the violations noted during the inspection and that the violations do not pose a serious public health risk.  This revised policy does not apply to third party reprocessors.

FDA will still enforce requirements for registration and device listing

As stated in the Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals (SUD enforcement guidance),[1] which was published by FDA on August 14, 2000, the Agency will actively enforce registration and device listing requirements for all hospital SUD reprocessors. These requirements remain unchanged and will be actively enforced by FDA immediately.

Examples of completed registration and device listing forms

To facilitate hospital SUD reprocessor registration and device listing, we have provided an example of a completed FDA Form 2891 "Initial Registration of Device Establishment" (see Attachment A).  Hospital reprocessors that are registering for the first time with FDA must use this form.  Also enclosed is an example of a completed FDA Form 2892 "Device Listing" (see Attachment B).   This form must be used to identify the SUDs that a hospital reprocesses.

Additional details regarding registration and listing are available in "CDRH Guidance for Industry: Instructions for Completion of Medical Device Registration and Listing Forms FDA-2891, 2891a, and 2892."    You may obtain a copy by calling Facts-on-Demand at 1-800-899-0381 or 301-827-0111 (please specify number 012 when prompted for the document number).

Where to obtain registration and listing forms

Registration forms are available from FDA's Internet site.  Because the device listing forms are uniquely numbered, they are not available from our Internet site. 

You may obtain registration and listing forms from the Division of Small Manufacturers, International, and Consumer Assistance by e-mailing dsma@cdrh.fda.gov or by faxing 301-443-8818.  Please provide your name, address, telephone number, and the quantity of forms you need.  (Note that a separate FDA Form 2892 form must be submitted for each category or type of device that a hospital reprocesses.)

Completing and submitting registration and listing forms

FDA has created a new identification code to identify establishments that reprocess medical devices.  The new code is "MB".  When completing the establishment registration form, select the code "MB" under section "9. Establishment Type" and write in this code under section "12. Establishment Name and Address" on the device listing form.  Please note that completed registration and listing forms must be submitted together.  If you submit the forms separately, they will be returned to you.   

FDA will still enforce requirements for premarket submissions

There are no changes to the premarket submission requirements[2] or to FDA's timetable for enforcing these requirements.  Hospital SUD reprocessors must submit to FDA, a PMA or a 510(k) for any class III, non-exempt class II, or non-exempt class I device that they reprocess.  As described in the SUD enforcement guidance, FDA's deadline for enforcement of PMA or 510(k) submission requirements for class III devices was February 14, 2001. The enforcement date for the submission of a 510(k) for a non-exempt class II SUD was August 14, 2001.  The enforcement date for the submission of a 510(k) for a non-exempt class I SUD is February 14, 2002.  (See the SUD enforcement guidance for additional details.)  FDA intends to actively enforce the premarket submission requirements.

Recommendations

If your hospital is reprocessing SUDs, we strongly encourage you to immediately register your facility and to list the devices that you are reprocessing with FDA, if you have not already done so.  Failure to comply with this requirement may cause your devices to be violative under the Federal Food, Drug and Cosmetic Act.[3]

We also encourage you to explore our Internet site for information and guidance on the SUD reuse issue.  For additional information, you may consult with the Division of Small Manufacturers, International, and Consumer Assistance by calling 1-800-638-2041 or e-mailing DSMA@CDRH.fda.gov.

Attachments (2)

 Attachment A: Sample of a Completed Initial Registration Form

FORM FDA 2891  (8/00)                              PREVIOUS EDITIONS ARE OBSOLETE                               EF

Attachment B: Sample of a Completed Device Listing Form

FORM FDA 2892  (1/99)                            PREVIOUS EDITIONS ARE

[1] A copy of the SUD enforcement guidance is available on FDA's Internet site or by calling CDRH Facts on Demand at 1-800-899-0381 or by calling 301-827-0111, specify number 1168 when prompted for the document shelf number.