69 FR 71 pgs. 19433-19435 - Medical Devices; Semicritical Reprocessed Single-Use Devices;Termination of Exemptions From Premarket Notification; Requirement forSubmission of Validation Data
Type: NOTICEVolume: 69Number: 71Pages: 19433 - 19435
Docket number: [Docket No. 2004N-0154]
FR document: [FR Doc. 04-8307 Filed 4-12-04; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0154]
Medical Devices; Semicritical Reprocessed Single-Use Devices;Termination of Exemptions From Premarket Notification; Requirement forSubmission of Validation Data
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) ispublishing a list of semicritical reprocessed single-use devices (SUDs)whose exemption from premarket submission is being terminated and for whichvalidation data, as specified under the Medical Device User Fee andModernization Act of 2002 (MDUFMA), are necessary in a premarketnotification (510(k)). FDA is requiring submission of these data to ensurethat these reprocessed SUDs are substantially equivalent to predicatedevices in accordance with MDUFMA.
DATES:
These actions are effective April 13, 2004.Manufacturers of reprocessed SUDs identified in the list whose exemptionsare being terminated must submit 510(k)s for these devices by July 13, 2005, or these devices may no longer be legallymarketed.
ADDRESSES:
Submit written comments to the Division ofDockets Management (HFA-305), Food and Drug Administration, 5630Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments . Identify comments withthe docket number found in brackets in the heading of thisdocument.
FOR FURTHER INFORMATION CONTACT:
Barbara A.Zimmerman, Center for Devices and Radiological Health (HFZ-410), Foodand Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,301-594-2036.
SUPPLEMENTARY INFORMATION:
I. Background
On October 26, 2002, MDUFMA (Public Law 107-250) amended theFederal Food, Drug, and Cosmetic Act (the act) by adding section 510(o) (21U.S.C. 360(o)), which provided new regulatory requirements for reprocessedSUDs. According to this new provision, 510(k)s for certain reprocessedSUDs identified by FDA must include validation data to ensure that thereprocessed SUDs are substantially equivalent to predicate devices. Therequired validation data include cleaning and sterilization data, andfunctional performance data demonstrating that each SUD will remainsubstantially equivalent to its predicate device after the maximum numberof times the device is reprocessed as intended by the person submitting thepremarket notification.
Before the enactment of the new law, the agency required a manufacturerof a reprocessed SUD to obtain premarket approval or premarket clearancefor the device, unless the device was exempt from premarket submissionrequirements. Under MDUFMA, some previously exempt critical andsemicritical reprocessed SUDs will no longer be exempt from premarketnotification requirements. Manufacturers of these identified devices willneed to submit 510(k)s that include validation data as specified by FDA.
Under section 302(b) of MDUFMA, a reprocessed SUD is defined as an
"original device that has previously been used on apatient and has been subjected to additional processing and manufacturingfor the purpose of an additional single use on a patient. The subsequentprocessing and manufacture of a reprocessed single-use device shall resultin a device that is reprocessed within the meaning of thisdefinition."
Reprocessed SUDs are divided into the following three categories: (1)Critical, (2) semicritical, and (3) noncritical. The first two categoriesreflect definitions contained in MDUFMA, and all three reflect aclassification scheme recognized in the industry.1These categories of devices are defined as follows:
Footnotes:
1 Spaulding, E. H., "The Role of ChemicalDisinfection in the Prevention of Nosocomial Infections," P. S.Brachman and T. C. Eickof (ed), Proceedings of International Conference onNosocomial Infections, 1970, American Hospital Association, Chicago,1971:254-274.
1. A critical reprocessed SUD is intended to contactnormally sterile tissue or body spaces during use.
2. A semicritical reprocessed SUD is intended to contactintact mucous membranes and not penetrate normally sterile areas of thebody.
3. A noncritical reprocessed SUD is intended to maketopical contact and not penetrate intact skin.
In the Federal Register of April 30, 2003 (68 FR 23139),FDA explained its methodology and criteria for determining which devicetypes should no longer be exempt from premarket submission requirements inaccordance with MDUFMA. As described in the April 2003 FederalRegister notice, in the first step of this process, the agencycategorized all known types of SUDs that were being reprocessed ascritical, semicritical, or noncritical using the previously listeddefinitions. Next, FDA evaluated the overall risk (high, moderate, or low)associated with the reprocessed SUDs using the review prioritization scheme(RPS) that had been previously described in a draft guidancedocument.2 In the RPS guidance, FDA set forth factorsthat could be used to evaluate the risk associated with reprocessed SUDsand assign an overall risk to each SUD based on the risk of the following:(1) Infection and (2) inadequate performance following reprocessing. Thedesignation of "high risk" was assigned to those devices thatposed the greatest risk of infection and inadequate performance afterreprocessing.
Footnotes:
2 The draft guidance entitled "Reprocessingand Reuse of Single-Use Devices: Review Prioritization Scheme"(appendix 2 superseded) is available on the Center for Devices andRadiological Health's (CDRH) Web site at http://www.fda.gov/cdrh/reuse/1156.pdf .
In addition to the previously listed steps, FDA also identified allreprocessed SUDs intended to come in contact with tissue at high risk ofbeing infected with the causative agents of Creutzfeldt-Jakob Disease(CJD). As stated in the April 2003 Federal Register notice,these are generally devices intended for use in neurosurgery andophthalmology. This criterion was used in FDA's evaluation becauseinsufficient scientific information exists at this time to establishstandard methods to eliminate CJD infectious agents.
Using this process and criteria, FDA developed a reference list(attachment 1 of the April 2003 Federal Register notice).This list identifies the entire group of reprocessed SUDs, and the levelsof risk associated with the devices, that FDA considered when implementingthe new statutory requirements in section 510(o) of the act. (For moredetailed information on the process FDA used to identify these SUDs andassign risk categorizations, see 68 FR 23139.)
II. Requirements for 510(k) Exempt Critical Reprocessed SUDs
In the April 2003 Federal Register notice, as required byMDUFMA, FDA published a list of critical reprocessed SUDs whose exemptionsfrom premarket submission were being terminated and for which validationdata in 510(k) submissions would be necessary. In the notice, FDAidentified those critical reprocessed SUDs that were either"high" risk, as described previously, or intended to come incontact with tissue at high risk of being infected with the causativeagents of CJD (see list I of the April 2003 Federal Register notice). FDA also published a revised version of this list in the Federal Register of June 26, 2003 (68 FR 38071).
III. Requirements for 510(k) Exempt Semicritical Reprocessed SUDs
As discussed previously, MDUFMA also requires FDA to review thesemicritical reprocessed SUDs that are currently exempt from premarketnotification requirements and determine which of these devices will require510(k)s with validation data in order to ensure their substantialequivalence to predicate devices. FDA is required to identify thesedevices in a notice published in the Federal Register byApril 26, 2004. The attached list of semicritical reprocessed SUDsimplements this MDUFMA requirement. Using the methodology and criteriadescribed in this document for developing the list of critical reprocessedSUDs, the agency determined which semicritical reprocessed SUDs should besubject to premarket submission requirements. All devices identified inthe attached list have been determined to be high risk semicriticalreprocessed SUDs. It should be noted that not all exempt semicriticaldevices have been listed. Semicritical reprocessed SUDs that are notlisted at this time may be added to future updates of the list.
As required by MDUFMA, manufacturers of the devices identified in theattached list must submit 510(k)s that include validation data regardingcleaning, sterilization, and functional performance, in addition to all theother required elements of 510(k)s identified in 21 CFR 807.87, within 15months of publication of this notice or they may no longer legally marketthese devices after that date.
| 21 CFR Section | Classification Name | Product Code for Nonreprocessed Device | Product Code for Reprocessed Device | Product Code Name for Reprocessed Device |
|---|---|---|---|---|
| 872.5410 | Orthodontic appliance and accessories | EJF | NQS | Orthodontic metal bracket |
| 876.4680 | Ureteral stone dislodger | FGO, FFL | NQT, NQU | Flexible and basket stone dislodger |
| 868.6810 | Tracheobronchial suction catheter | BSY | NQV | Tracheobronchial suction catheter |
IV. Requirements for 510(k) Exempt Noncritical Reprocessed SUDs
MDUFMA does not require FDA to take any action under section 510(o) ofthe act for noncritical reprocessed SUDs that are exempt from premarketsubmission requirements.
V. Stakeholder Input
In the Federal Register of February 4, 2003 (68 FR 5643),FDA invited interested persons to provide information and share views onthe implementation of MDUFMA. Since that time, the agency has receivedcomments on various MDUFMA provisions, including several on itsimplementation of section 510(o) of the act. One comment expressed concernabout the agency's reliance on the Review Prioritization Scheme (RPS).According to the comment, the RPS is a subjective and incomplete method foraccurately assessing the risk associated with reprocessing. The commentfurther stated that Congress's intent was for the Spaulding criteria to bethe primary mechanism used to determine whether the exempt status ofreprocessed SUDs remains appropriate.
As stated in the April 30, 2003 Federal Register notice,the agency continues to believe that the RPS is an appropriate risk-basedtool for identifying those devices that are likely to raise concerns aboutboth infection transmission and inadequate performance followingreprocessing. FDA believes that the flowchart that is part of the RPSprovides an objective, science-based assessment of these risks for eachtype of reprocessed device. In addition, while MDUFMA defines the terms"critical reprocessed single-use device" and"semi-critical reprocessed single-use device" in new section201(mm)(1) and (mm)(2) of the act, new section 510(o)(2)(A) states that"[t]he Secretary shall identify such devices or types of devices forwhich such exemptions should be terminated in order to provide a reasonableassurance of the safety and effectiveness of the devices." Giventhis statutory language, FDA believes that while Congress used theSpaulding definitions to initially categorize reprocessed SUDs, Congressalso authorized the agency to apply additional criteria in determining thedevices for which 510(k) exemptions should be terminated.
The agency also received a comment that identified specific reprocessedSUDs whose exemption from the 510(k) requirements should be terminated.The agency considered these recommendations while finalizing this document.Although this list of semicritical reprocessed SUDs does not include all ofthose devices that were recommended in the comment, the agency believesthat 510(k)s with validation data should be required in accordance withMDUFMA for the devices identified on the list due to concerns aboutinfection transmission and performance. As stated in the April 2003 Federal Register notice, the agency recognizes that the lists ofcritical and semicritical devices may need to be reevaluated and updatedover time. Therefore, FDA will consider comments from the public onadditional devices that should be included on the lists at any time.
Finally, FDA would like to take this opportunity to remind entities thatreprocess SUDs of the guidance document entitled "Medical Device UserFee and Modernization Act of 2002, Validation Data in PremarketNotification Submissions [510(k)s] for Reprocessed Single-Use MedicalDevices." FDA announced the availability of this guidance in the Federal Register of July 8, 2003 (68 FR 40679). This guidancedocument provides FDA's recommendations for manufacturers of reprocessedSUDs to assist them in complying with MDUFMA's validation data submissionrequirement and should be helpful to manufacturers of those semicriticalreprocessed SUDs listed below in preparing their 510(k)s. This guidancemay be found on CDRH's Web site at http://www.fda.gov/cdrh/guidance/html .
VI. Paperwork Reduction Act of 1995
This document contains information collection provisions that aresubject to review by the Office of Management and Budget (OMB) under thePaperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Thecollection of information described in this document were approved underOMB control number 0910-0514.
VII. Comments
Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding thisdocument at any time. Submit a single copy of electronic comments or twopaper copies of any mailed comments, except that individuals may submit onepaper copy. Comments are to be identified with the docket number found inbrackets in the heading of this document. Received comments may be seen inthe Division of Dockets Management between 9 a.m. and 4 p.m., Mondaythrough Friday.
Dated: April 5, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-8307 Filed 4-12-04; 8:45 am]
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