This collection
is approved per FDA's memo of 7/17/01.
Inventory as of this Action
Requested
Previously Approved
09/30/2004
09/30/2004
08/31/2001
487
0
1
107,321
0
67,766
0
0
0
Section 515 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C. 360(e)) sets forth
requirements for premarket approval of certain medical devices. The
implementing regulations, contained in 21 CFR Part 814, further
specify the contents of a PMA for a medical device and the criteria
FDA will employ in approving, denying, or withdrawing approval of a
PMA and supplements to PMA's. The regulation's purpose is to
establish an efficient and thorough procedure for FDA's review of
PMA's and supplements to PMA's for class III (premarket approval)
medical devices. The regulations also ensure the.....
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.