[Federal Register: December 16, 2003 (Volume 68, Number 241)]
[Page 70019-70021]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0542]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Premarket Notification Submissions

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 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements for premarket notification (510(k)) submissions.

DATES: Submit written and electronic comments on the collection of 
information by February 17, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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, including 
each proposed extension of an existing 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

[[Page 70020]]

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.

Premarket Notification 510(k) Submissions--21 CFR Part 807 (OMB Control 
Number 0910-0120)--Extension

    Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360(k)) requires a person who intends to market a 
medical device to submit a 510(k) submission to FDA at least 90 days 
before proposing to begin the introduction, or delivery for 
introduction into interstate commerce, for commercial distribution of a 
device intended for human use. The definition of ``person'' has been 
expanded to include hospitals who re-use or re-manufacture single-use 
medical devices. The Medical Device User Fee and Modernization Act of 
2002 (MDUFMA) (Public Law 107-250), added section 510(o) to the act to 
establish new regulatory requirements for reprocessed single-use 
devices (SUDs) (MDUFMA section 302(b), the act section 510(o)). MDUFMA 
was signed into law on October 26, 2002. Section 301(b) of MDUFMA adds 
new requirements for reprocessed SUDs to section 510 of the act. The 
estimated submissions below include those submitted by hospitals re-
manufacturing single-use medical devices.
    Section 510(k) of the act allows for exemptions to the 510(k) 
submissions, i.e., a 510(k) submission would not be required if FDA 
determines that premarket notification is not necessary for the 
protection of the public health, and they are specifically exempted 
through the regulatory process. Under 21 CFR 807.85 ``Exemption from 
premarket notification,'' a device is exempt from premarket 
notification if the device intended for introduction into commercial 
distribution is not generally available in finished form for purchase 
and is not offered through labeling and advertising by the 
manufacturer, importer, or distributor for commercial distribution. In 
addition, the device must meet one of the following conditions: (1) It 
is intended for use by a patient or dentist (or other specially 
qualified persons), or (2) it is intended solely for use by a physician 
or dentist and is not generally available to other physicians or 
    A commercial distributor who places a device into commercial 
distribution for the first time under their own name and a repackager 
who places their own name on a device and does not change any other 
labeling or otherwise affect the device, shall be exempted from 
premarket notification if the device was legally in commercial 
distribution before May 28, 1976, or a premarket notification was 
submitted by another person.
    One of MDUFMA's provisions requires the submission of validation 
data specified in the statute for certain reprocessed SUDs (as 
identified by FDA) such as cleaning and sterilization data, and 
functional performance data. FDA offers a guidance document to assist 
reprocessors of single use devices in submitting MDUFMA mandated 
validation data for the devices.
    MDUFMA requires that FDA review the types of reprocessed SUDs not 
subject to premarket notification requirements and identify which of 
these devices require the submission of validation data to ensure their 
substantial equivalence to predicate devices. MDUFMA also requires that 
FDA review critical and semi-critical reprocessed SUDs that are 
currently exempt from premarket notification requirements and determine 
which of these devices require the submissions of 510(k)s to ensure 
their substantial equivalence to predicate devices. Under MDUFMA, FDA 
will use the validation data submitted for a reprocessed SUD to 
determine whether the device will remain substantially equivalent in 
terms of safety and effectiveness to its predicate after the maximum 
number of times the device is reprocessed as intended by the person 
submitting the premarket notification.
    The information collected in a premarket notification is used by 
the medical, scientific, and engineering staffs of FDA in making 
determinations as to whether or not devices can be allowed to enter the 
U.S. market. The premarket notification review process allows for 
scientific and/or medical review of devices, subject to section 510(k) 
of the act, to confirm that the new devices are as safe and as 
effective as legally marketed predicate devices. This review process, 
therefore, prevents potentially unsafe and/or ineffective devices, 
including those with fraudulent claims, from entering the U.S. market. 
This information will allow FDA to collect data to ensure that the use 
of the device will not present an unreasonable risk for the subject's 
rights. The respondents to this information collection will primarily 
be medical device manufacturers and businesses.
    FDA Form 3514 was developed to assist respondents in categorizing 
510(k) data for submission to FDA. This form also assists respondents 
in organizing and submitting data for other FDA medical device programs 
such as premarket approval applications, investigational device 
exemptions, and humanitarian device exemptions.
    FDA estimates the burden of this collection of information to be as 

                                 Table 1.--Estimated Annual Reporting Burden\1\
  21 CFR                                          Annual Frequency     Total Annual     Hours per
  Section       Form No.     No. of Respondents     per Response        Responses       Response     Total Hours
Part 807,   ...............              4,000                   1            4,000            80       320,000
 Subpart E
                  FDA 3514               2,000                   1            2,000            .5         1,000
Submission  ...............                 20                   5              100            40        28,000
 n data
Totals      ...............  ..................  ..................  ...............  ............      349,000
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

[[Page 70021]]

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
  21 CFR                           Annual Frequency per      Total Annual        Hours per
 Section    No. of Recordkeepers      Recordkeeping            Records            Record          Total Hours
807.93                    2,000                     10              20,000              0.5              10,000
Totals     .....................  .....................  ..................  ...............             10,000
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    FDA has based these estimates on conversations with industry and 
trade association representatives, and from internal review of the 
documents listed in tables 1 and 2 of this document.
    The total burden for using voluntary FDA Form 3514 is estimated to 
be approximately 1,000 hours and has been included in this collection 
of information. Once this collection of information has been approved, 
the burden for FDA Form 3514 will be reported and approved in each of 
the following OMB information collections: (1) Investigational device 
exemption reports and records (OMB control number 0910-0078), (2) 
premarket approval of medical devices (OMB control number 0910-0231), 
and (3) medical devices, humanitarian devices (OMB control number 0910-

    Dated: December 9, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-30964 Filed 12-15-03; 8:45 am]