Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a list (List I) of critical reprocessed single-use devices (SUDs) whose exemption from premarket submission is being terminated and for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), is necessary in a premarket notification (510(k)); and a list (List II) of reprocessed SUDs that are currently subject to 510(k) requirements for which FDA has determined that validation data, as specified under MDUFMA, is necessary in a 510(k). FDA is requiring submission of these data to ensure that these reprocessed SUDs are substantially equivalent to predicate devices in accordance with MDUFMA.

DATES:

These actions are effective April 30, 2003. Manufacturers of SUDs identified in List I whose exemption is being terminated must submit 510(k)s for these devices by July 30, 2004, or their devices may no longer be marketed. Manufacturers who already have clearance letters for SUDs identified in List II must submit validation data for these devices by January 30, 2004, or marketing of these devices must cease.

ADDRESSES:

Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments . Comments on Lists I and II should be identified with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Barbara A. Zimmerman, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850.

SUPPLEMENTARY INFORMATION:

I. Background

On October 26, 2002, MDUFMA (Pub. L. 107-250), amended the Federal Food, Drug, and Cosmetic Act (the act) by adding section 510(o) (21 U.S.C. 360(o)), which provided new regulatory requirements for reprocessed SUDs. According to this new provision, in order to ensure that reprocessed SUDs are substantially equivalent to predicate devices, 510(k)s for certain reprocessed SUDs identified by FDA must include validation data. These required validation data include cleaning and sterilization data, and functional performance data demonstrating that each SUD will remain substantially equivalent to its predicate device after the maximum number of times the device is reprocessed as intended by the person submitting the premarket notification.

Before enactment of the new law, a manufacturer of a reprocessed SUD was required to obtain premarket approval or premarket clearance for the device, unless the device was exempt from premarket submission requirements. Under MDUFMA, some previously exempt reprocessed SUDs will no longer be exempt from premarket notification requirements. Manufacturers of these identified devices will need to submit 510(k)s that include validation data to be specified by FDA. Reprocessors of certain SUDs that are currently subject to cleared 510(k)s also will need to submit the validation data specified by the agency.

In the near future, FDA will publish a guidance document providing more specific information about the types of validation data that should be submitted in premarket notification submissions for the reprocessed SUDs listed in this notice.

A. Definitions

Under section 302(b) of MDUFMA, a reprocessed SUD is defined as an “original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. The subsequent processing and manufacture of a reprocessed single-use device shall result in a device that is reprocessed within the meaning of this definition.”

B. Reprocessed SUDs Exempt From Premarket Notification

Reprocessed SUDs are divided into three groups: (1) Critical, (2) semicritical, and (3) noncritical. The first two categories reflect definitions set forth in MDUFMA, and all three reflect a classification scheme recognized in the industry. These categories of devices are defined as follows:

(1) A critical reprocessed SUD is intended to contact normally sterile tissue or body spaces during use.

(2) A semicritical reprocessed SUD is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body.

(3) A noncritical reprocessed SUD is intended to make topical contact and not penetrate intact skin.

1. Requirements for Critical Reprocessed SUDs

MDUFMA requires FDA to review the critical reprocessed SUDs that are currently exempt from premarket notification requirements and determine which of these devices require premarket notification to ensure their substantial equivalence to predicate devices. By April 26, 2003, FDA must identify in a Federal Register notice those critical reprocessed SUDs whose exemption from premarket notification will be terminated. List I in this Federal Register notice implements this MDUFMA requirement.

In accordance with MDUFMA, manufacturers of the devices identified in List I must submit 510(k)s that include validation data regarding cleaning, sterilization, and functional performance, in addition to all the other required elements of a 510(k) identified in § 807.87 (21 CFR 807.87), within 15 months of publication of this notice or no longer market their device.

2. Requirements for Semicritical Reprocessed SUDs

MDUFMA also requires FDA to review the semicritical reprocessed SUDs that are currently exempt from premarket notification requirements and determine which of these devices require premarket notification to ensure their substantial equivalence to predicate devices. FDA must identify these devices in a notice published in the Federal Register by April 26, 2004. Manufacturers of devices identified at that time will be required to submit 510(k)s that include validation data regarding cleaning, sterilization, and functional performance in addition to all the other required elements of a 510(k) identified in § 807.87, within 15 months of publication of that notice or no longer market their device.

3. Requirements for Noncritical Reprocessed SUDs

MDUFMA does not require FDA to take any action under this section for noncritical SUDs that are exempt from premarket submission requirements.

C. Reprocessed SUDs Already Subject to Premarket Notification Requirements

MDUFMA also requires FDA to review the types of reprocessed SUDs already subject to premarket notification requirements and to identify which of these devices require the submission of validation data to ensure their substantial equivalence to predicate devices. FDA must publish a list of these devices in the Federal Register by April 26, 2003, and update the list as necessary. List II of this Federal Register notice implements this MDUFMA requirement. The devices on List II may be critical, semicritical, or noncritical reprocessed SUDs.

1. For devices identified in List II that have not yet been cleared through the 510(k) process, manufacturers must submit 510(k)s that include validation data regarding cleaning, sterilization, and functional performance, in addition to all the other required elements of a 510(k) identified in § 807.87, upon publication of this notice in order to market these devices. FDA will soon publish guidance to help submitters understand what types of validation data should be included in these 510(k)s.

2. For devices identified in List II that already have been cleared through the 510(k) process, manufacturers must submit validation data regarding cleaning, sterilization, and functional performance within nine months of publication of this notice or marketing must cease. FDA will soon publish guidance to explain how a 510(k) holder may submit the additional data now being required to support an earlier clearance.

II. FDA's Implementation of New Section 510(o) of the Act

FDA used a number of criteria to determine which device types should be included in the lists required by MDUFMA. As part of its consideration, FDA relied upon the Review Prioritization Scheme (RPS) it described in the February 2000 draft guidance document entitled “Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme.” In the RPS guidance, FDA set forth factors that could be used to evaluate risk associated with reprocessed SUDs. This approach assigned an overall risk to each SUD based on: (1) The risk of infection and (2) the risk of inadequate performance following reprocessing. Based on these risk factors, three categories of risk (high, moderate, and low) were developed. The designation of “high risk” was assigned to those devices that posed the greatest risk of infection and inadequate performance after reprocessing. In response to several comments about potential subjectivity of the RPS, FDA did not use the RPS approach when the agency finalized its enforcement priorities for reprocessed SUDs on August 14, 2000.

FDA has determined, however, that the RPS is an appropriate risk-based tool for developing the lists required by MDUFMA because the RPS identifies the devices that are likely to raise the most concerns about both infection transmission and inadequate performance following reprocessing. In formulating these lists, the agency also had the benefit of comments from stakeholders and an internal centerwide committee to evaluate the results of the RPS and ensure its consistency. In addition, there was a final review of all the devices on these lists by the Director of the Office of Device Evaluation. In this context, the agency believes these steps have adequately addressed concerns about the subjectivity of the RPS.

In addition to the previous criterion, FDA used one other criterion to identify those reprocessed SUDs that will be subject to the new requirements established by MDUFMA. The agency has included in these lists all reprocessed SUDs intended to come in contact with tissue at high risk of being infected with the causative agents of Creutzfeldt-Jakob Disease (CJD). These are generally devices intended for use in neurosurgery ophthalmology. This criterion was included in FDA's evaluation because insufficient scientific information exists at this time to establish standard methods to eliminate CJD infectious agents.

Therefore, in order to develop the two lists required by MDUFMA, FDA used the following process. First, the agency identified the types of SUDs that are being reprocessed. FDA did this by searching the 510(k) database for any 510(k)s that had been submitted for reprocessed SUDs and by asking original equipment manufacturers and reprocessors to provide information about types of devices that were being reprocessed. Second, FDA determined whether these devices are “critical,” “semi-critical,” or “non-critical”. (These definitions reflect the Spaulding classification and are the same definitions FDA used earlier in developing its RPS.) FDA then applied the criteria described previously and “listed” any reprocessed SUD that was either “high” risk according to the RPS or intended to come in contact with tissue at high risk of being infected with the causative agents of CJD.

All devices identified in List I (previously exempt from 510(k)) have been determined to be critical reprocessed SUDs. In addition to being critical, they are either high risk according to the RPS or intended to come in contact with tissue at high risk of being infected with CJD. It should be noted that not all exempt devices that are critical have been listed. Critical reprocessed SUDs that are not listed in List I at this time may be reconsidered in subsequent updates of the list. The devices in List II (devices currently subject to 510(k) requirements that now will require the submission of validation data) are either high risk according to the RPS or intended to come in contact with tissue at high risk of being infected with the causative agents of CJD.

FDA has also provided a reference list in Attachment 1. To show how FDA evaluated the risk of a specific device, Attachment 1 includes the entire group of devices FDA considered when identifying the reprocessed SUDs in Lists I and II, and shows how FDA applied the criteria that determined whether the device would be identified on either of these lists.

In the Federal Register of February 4, 2003 (68 FR 5643), FDA invited interested persons to provide information and share views on the implementation of MDUFMA. The agency received several comments that identified specific reprocessed SUDs to be included in Lists I and II. The agency considered these recommendations while finalizing this document. Although FDA's lists do not include all the reprocessed SUDs that were recommended, the agency believes that those devices that pose the greatest risk of infection transmission and inadequate performance have been identified. The agency recognizes, however, that these lists may need to be re-evaluated and updated over time. Therefore, FDA will consider comments from the public on additional devices that should be included in the lists at any time. The agency also notes that MDUFMA permits FDA to request validation data for a device type that is subject to 510(k) clearance but not yet included in List II. If this were to occur, FDA would ensure that manufacturers were aware of this change in the 510(k) submission requirements for that type of device by promptly updating the list.

Finally, FDA received one comment that suggested the agency's prior determinations about risk associated with reprocessed SUDs precluded FDA from now requiring 510(k)s for devices that were previously exempt or additional data for devices that were already cleared. FDA believes that this comment ignores the existence of MDUFMA's requirements. It is true that FDA had initially developed a regulatory approach for reprocessed SUDs that sought to treat those devices and original devices in a similar manner and that FDA had not required additional data to be submitted for certain reprocessed SUDs under that approach. However, through MDUFMA Congress clearly stated its intent to have the agency re-examine its policy with respect to reprocessed SUDs and legislated additional controls for those devices. FDA is committed to fulfilling its responsibilities under MDUFMA. The development and publication of these lists is part of the agency's implementation of these new statutory provisions.

III. Comments

You may submit written or electronic comments on these lists to the Dockets Management Branch (see ADDRESSES). You may submit a single copy of an electronic comment to http://www.fda.gov/dockets/ecomments . You should submit two copies of any mailed comments but individuals may submit one copy. You should identify your comment with the docket number found in brackets in the heading of this document. You may see any comments FDA receives in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.