[Federal Register: March 9, 2004 (Volume 69, Number 46)]
[Notices]
[Page 11022-11023]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09mr04-88]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
dentists.
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
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency per Hours per
21 CFR Section Form No. No. of Respondents Response Total Annual Responses Response Total Hours
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807 Subpart E (807.81 & 807.87- ............... 4,000 1 4,000 80 320,000
510(k))
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FDA 3514 2,000 1 2,000 .5 1,000
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Submission of Validation Data ............... 20 5 100 40 28,000
(2003)
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Totals ............... ....................... ........................ ....................... ........... 349,000
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\1\There are no capitol costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden \2\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Form No. Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
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807.93 .................. 2,000 10 20,000 .5 10,000
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Totals .................. .................. .................. .................. .................. 10,000
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\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-
0332).
Dated: March 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5196 Filed 3-8-04; 8:45 am]
BILLING CODE 4160-01-S