THIS INFORMATION
COLLECTION IS APPROVED THROUGH 1/86 TO PERMIT OMB TO PERFORM A
THOROUGH PRACTICAL UTILITY REVIEW. UPON RESUBMISSION FDA MU PROVIDE
OMB WITH A REPORT OF THE FIRST YEAR'S OPERATION OF THE MDR RUL THIS
REPORT SHOULD CONTAIN AN EXPLANATION OF HOW FDA USES THIS SYSTEM
FURTHER THE PROTECTION OF THE PUBLIC HEALTH. SPECIFICALLY, THE
REPORT MUST INCLUDE: 1. AN ACCOUNTING OF THE NUMBER AND TYPE OF
REPORTS (INCLUDING A BREAKDOWN OF TELEPHONE REPORTS AND FOLLOW-UP
REPORTS) FIL AND AN APPROPRIATE ADJUSTMENT OF THE ESTIMATED ANNUAL
BURDEN. 2. AN EXPLANATION OF HOW FDA HAS USED MDR REPORTS AS A
BASIS FOR REGULATORY ACTIONS, INCLUDING BUT NOT LIMITED TO,
ENFORCEMENT PROCEEDINGS, CONSIDERATION OF RECLASSIFICATION ACTIONS,
PMA REVIEW, 510 (K) REVIEW, WAIVER OF 510 (K) REQUIREMENTS, AND THE
DEVELOPMENT OF PERFORMANCE STANDARDS. 3. AN ACCOUNTING OF THE
NUMBER OF INSTANCES (AND EXPLANATI THEREOF) IN WHICH FDA NOTIFIED A
MANUFACTURER OR IMPORTER THAT A RECOR IS NO LONGER NECESSARY
PURSUANT TO 21 CFR 803.24 (D)(4). 4. COPIES OF ALL EXISTING
INTERNAL AND PUBLIC DOCUMENTS THAT HAVE BEEN DEVELOPED TO PROVIDE
FDA OFFICIALS, OR THE PUBLIC, WITH INFORMATION STEMMING FROM M
REPORTS. IN ITS FEDERAL REGISTER NOTICE FDA SHOULD STATE THAT THE
SYSTEM HAS BEEN APPROVED FOR ONE YEAR AND THAT A PRACTICAL UTILITY
REVIEW WILL BE CONDUCTED BASED UPON ONE YEAR'S EXPERIENCE. FINALLY,
A REGULATORY GUIDELINES OF GENERAL APPLICABILITY FOR THE MDR MUST
BE SUBMITTED FOR PRA APPROVAL.
Inventory as of this Action
Requested
Previously Approved
01/31/1986
01/31/1986
27,660
0
0
109,376
0
0
0
0
0
REQUIRES A MANUFACTURER OR IMPORTER OF
MEDICAL DEVICES TO REPORT TO FD WHENEVER THEY POSSESS INFORMATION
THAT REASONABLY SUGGESTS THAT A DEVICE HAS CAUSED OR CONTRIBUTED TO
A DEATH OR SERIOUS INJURY. IMPORTERS ARE REQUIRED TO ESTABLISH AND
MAINTAIN FILES OF REPORTS AND RECORDS.
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.
MEDICAL DEVICE REPORTING