Medical Device Link.

Originally Published PMPN July 2001

Regulatory Focus

The agency's new draft guidance clarifies issues related to premarket submissions for reprocessed single-use medical devices.

Last year, after a long controversy, FDA's Center for Devices and Radiological Health (CDRH) issued a guidance stipulating the requirements for reprocessing single-use devices (SUDs). That document specified that reprocessed devices are subject to the same CDRH approval process—premarket approval (PMA) or premarket notification (510(k))—as original unused devices.

The agency has released a new draft guidance on premarket regulatory and technical issues for reprocessed single-use medical devices. Published May 24, 2001, the guidance clarifies issues related to premarket submissions for reprocessed SUDs. It can be viewed at http://www.fda.gov/cdrh/ode/guidance/1331.html.

The guidance clarifies that there is no difference between an SUD reprocessor and an OEM whose device triggers a premarket requirement as described in 21 CFR 807. There are no additional regulatory requirements, nor are there allowances from existing requirements, just because the device is a reprocessed SUD. Every premarket process available to OEMs is also available to SUD reprocessors, including special and abbreviated 510(k) submissions and modular PMA applications.

In a 510(k) submission, the re-processed device must have the same intended use as the predicate device, which can be the SUD of the OEM. The reprocessor must show that the device is equivalent to the predicate in terms of safety and effectiveness of design, sterility, biocompatibility, strength of materials, and functionality.

In a PMA application, the reprocessor must not only demonstrate the safety and effectiveness of the device, but also must evaluate the unique characteristics of the device, which may include design, sterility, biocompatibility, strength of materials, and clinical functionality. In both the PMA and 510(k) processes, merely submitting the steps used in reprocessing the device is not sufficient.

If the reprocessor labels the reprocessed SUD for multiple use, the device should be labeled with adequate instructions for the end-user on how to reprocess the device. Validated directions for cleaning, sterilizing, or disinfecting the device should also be included. For a PMA application, labels on reprocessed SUDs should include validation data and information on the entire reprocessing procedure. Devices reprocessed for multiple use should be handled in accordance with the April 1996 guidance "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities" and its September 1996 question-and-answer document.

Reprocessed SUDs must be labeled according to the requirements of the Federal Food, Drug, and Cosmetic Act and 21 CFR 801. PMA and 510(k) submissions must include the proposed labeling for the reprocessed SUD. CDRH intends to post additional information about labeling reused devices on-line at http://www.fda.gov/cdrh/reuse/index.shtml.

Reviewers of 510(k) applications will be vigilant for any differences in the labeling of the reprocessed device compared to the predicate that may create a new intended use, which would require a PMA.

Only closely related variations of the same type of reprocessed device should be grouped in one PMA or 510(k) submission. Reprocessors should examine device groupings that OEMs have developed in previous submissions as models that may be useful in grouping their own submissions. If a group of devices is combined into one submission, data and information covering each device must be included.

The reprocessor should get a "right of reference" from the OEM if there is any information on file at FDA that can help the reprocessor gain marketing clearance or approval. This will allow FDA to review that information on behalf of the reprocessor.

Validation data should come from the specific device or justify why another device was tested. Tests used to support design specifications and quality control procedures should include SUD samples with the full range of tolerances.

Cleaning protocols and simulations should be rigorous and relevant. For critical devices, a sterility assurance level of one in one million nonsterile units should be demonstrated.

Unlike premarket evaluations, quality system evaluations should address the following: incoming product control and acceptance, production and process controls of nonconforming product, tracking the number of times a device has been reprocessed, and sterilization and cleaning validations.

FDA's rules for reprocessing SUDs will not apply for permanently implanted pacemakers, hemodialyzers, and opened but unused SUDs. And for now, its rules do not apply in healthcare facilities that are not hospitals, but that could change.

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