56910 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0389] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Reprocessed 

Single-Use Device Labeling 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

reprocessed single-use device labeling. 

DATES: Submit written or electronic 

comments on the collection of 

information by November 28, 2005. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://www.fda.gov/ 

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Reprocessed Single-Use Device 

Labeling (21 U.S.C. 352(u)) 

Section 502 of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

352), among other things, establishes 

requirements that the label or labeling of 

a medical device must meet so that it is 

not misbranded and subject to 

regulatory action. The Medical Device 

User Fee and Modernization Act of 2002 

(MDUFMA) (Public Law 107–250) 

amended section 502 of the act to add 

section 502(u) to require devices (both 

new and reprocessed) to bear 

prominently and conspicuously the 

name of the manufacturer, a generally 

recognized abbreviation of such name, 

or a unique and generally recognized 

symbol identifying the manufacturer. 

Section 2(c) of The Medical Device User 

Fee Stabilization Act of 2005 (MDUFSA) 

(Public Law 109–43) amends section 

502(u) of the act by limiting the 

provision to reprocessed single-use 

devices (SUDs) and the manufacturers 

who reprocess them. Under the 

amended provision, if the original SUD 

or an attachment to it prominently and 

conspicuously bears the name of the 

manufacturer, then the reprocessor of 

the SUD is required to identify itself by 

name, abbreviation, or symbol, in a 

prominent and conspicuous manner on 

the device or attachment to the device. 

If the original SUD does not 

prominently and conspicuously bear the 

name of the manufacturer, the 

manufacturer who reprocesses the SUD 

for reuse may identify itself using a 

detachable label that is intended to be 

affixed to the patient record. MDUFSA 

was enacted on August 1, 2005, and 

becomes self-implementing on August 

1, 2006. 

The requirements of section 502(u) of 

the act impose a minimal burden on 

industry. This section of the act only 

requires the manufacturer, packer, or 

distributor of a device to include their 

name and address on the labeling of a 

device. This information is readily 

available to the establishment and easily 

supplied. From its registration and 

premarket submission database, FDA 

estimates that there are 3 establishments 

that distribute approximately 300 

reprocessed SUDs. Each response is 

anticipated to take 0.1 hours resulting in 

a total burden to industry of 30 hours. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of the act No. of 

Respondents 

Annual Responses 

Per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

502(u) 3 100 300 0.1 30 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 56911 

1Spaulding, E.H., ‘‘The Role of Chemical 

Disinfection in the Prevention of Nonsocomial 

Infections,’’ P.S. Brachman and T.C. Eickof (ed), 

Proceedings of International Conference on 

Nonsocomial Infections, 1970, American Hospital 

Association, Chicago, 254-274, 1971. 

Dated: September 22, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19509 Filed 9–28–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2003N–0161] (formerly Docket 

No. 03N–0161) 

Medical Devices; Reprocessed SingleUse 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 adding 

noncompression heart stabilizers to the 

list of critical reprocessed single-use 

devices (SUDs) whose exemption from 

premarket notification requirements has 

been terminated and for which 

validation data, as specified under the 

Medical Device User Fee and 

Modernization Act of 2002 (MDUFMA), 

are necessary in a premarket notification 

(510(k)). The agency is also adding 

laparoscopic and endoscopic 

electrosurgical accessories to the list of 

reprocessed SUDs currently subject to 

premarket notification requirements that 

will now require submission of 

supplemental validation data. FDA is 

requiring submission of these data to 

ensure that reprocessed single-use 

noncompression heart stabilizers and 

laparoscopic and endoscopic 

electrosurgical accessories are 

substantially equivalent to predicate 

devices, in accordance with MDUFMA. 

DATES: These actions are effective 

September 29, 2005. Manufacturers of 

reprocessed single-use noncompression 

heart stabilizers must submit 510(k)s for 

these devices by December 29, 2006, or 

their devices may no longer be legally 

marketed. Manufacturers of reprocessed 

single-use laparoscopic and endoscopic 

electrosurgical accessories who already 

have 510(k) clearance for these devices 

must submit supplemental validation 

data for the devices by June 29, 2006, or 

their devices may no longer be legally 

marketed. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(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 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, 301–443–8320, ext. 158. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On October 26, 2002, MDUFMA 

(Public Law 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 are no longer 

exempt from premarket notification 

requirements. Manufacturers of these 

identified devices were required to 

submit 510(k)s that included validation 

data specified by FDA. Reprocessors of 

certain SUDs already subject to cleared 

510(k)s were also required to submit the 

validation data specified by the agency. 

The reprocessed SUDs subject to these 

new requirements were listed in the 

Federal Register as required by 

MDUFMA. In accordance with section 

510(o) of the act, FDA shall revise the 

lists as appropriate. This notice adds 

two types of reprocessed SUDs to the 

lists of devices subject to MDUFMA’s 

data submission requirements. 

Noncompression heart stabilizers are 

being added to the list of previously 

exempt reprocessed SUDs that now 

require the submission of 510(k)s 

containing validation data. 

Laparoscopic and endoscopic 

electrosurgical accessories are being 

added to the list of reprocessed SUDs, 

already subject to premarket notification 

requirements, for which supplemental 

validation data are required. 

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.’’

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.1 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. 

B. Critical and Semicritical Reprocessed 

SUDs Previously Exempt From 

Premarket Notification 

MDUFMA required FDA to review the 

critical and semicritical reprocessed 

SUDs that were previously exempt from 

premarket notification requirements and 

determine which of these devices 

required premarket notification to 

ensure their substantial equivalence to 

predicate devices. By April 26, 2003, 

FDA was required to identify in a 

Federal Register notice those critical 

reprocessed SUDs whose exemption 

from premarket notification would be 

terminated and for which FDA 

determined that validation data, as 

specified under MDUFMA, was 

necessary in a 510(k). According to the 

law, manufacturers of the devices whose 

exemptions from premarket notification 

were terminated were required to 

submit 510(k)s that included 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