This collection
expired on 8/31/93 and was in use for five years without OMB
approval. This is a clear violation of the Paperwork Reduction Act.
FDA shall take careful steps to ensure that this an administrative
error shall not occur with this collection in the future.
Inventory as of this Action
Requested
Previously Approved
10/31/2001
10/31/2001
5,000
0
0
410,000
0
0
0
0
0
Section 510(k) of the Federal Food,
Drug, and Cosmetic Act (the Act) and the implementing regulation,
21 CFR 807.81, require a person/manufacturer who intends to market
a medical device to submit a premarket notification 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. Based on the
informaton provided in the notification, FDA must determine whether
the new device is substantially equivalent to a legally marketed
device, as defined in 21 CFR 807.92(a)(3).
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.