[Federal Register: March 9, 2004 (Volume 69, Number 46)]
[Page 11022-11023]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0542]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Premarket 
Notification Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April 
8, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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) (section 302(b) of MDUFMA, section 510(o) of the act). 
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

[[Page 11023]]

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\
                                                                               Annual Frequency per                              Hours per
          21 CFR Section               Form No.        No. of Respondents            Response           Total Annual Responses    Response   Total Hours
807 Subpart E (807.81 & 807.87-    ...............                    4,000                        1                     4,000           80      320,000
                                         FDA 3514                     2,000                        1                     2,000           .5        1,000
Submission of Validation Data      ...............                       20                        5                       100           40       28,000
Totals                             ...............  .......................  ........................  .......................  ...........      349,000
\1\There are no capitol costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2.--Estimated Annual Recordkeeping Burden \2\
                                                                  No. of         Annual Frequency      Total Annual          Hours per
            21 CFR Section                   Form No.          Recordkeepers     per Recordkeeping        Records          Recordkeeper      Total Hours
807.93                                  ..................              2,000                  10              20,000                  .5        10,000
Totals                                  ..................  ..................  ..................  ..................  ..................       10,000
\2\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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: March 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5196 Filed 3-8-04; 8:45 am]