[Federal Register Volume 59, Number 198 (Friday, October 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25517]


[[Page Unknown]]

[Federal Register: October 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

Temporary Deferment of Activities Relating to Medical Device 
Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
Office of Device Evaluation (ODE), Center for Devices and Radiological 
Health (CDRH) will be moving in October 1994. During the period 
required for relocation of files, equipment, and agency personnel, the 
agency will not officially receive premarket notifications, premarket 
approval applications (PMA's), or investigational device exemption 
(IDE) applications, and the agency's review of pending submissions will 
be delayed. The statutory review period on pending submissions will be 
suspended during this period needed for relocation of ODE. ODE will 
renew work on and will officially receive submissions after the 
relocation is completed. FDA estimates that the deferment period will 
be 7 calendar days, but it may be up to 14 days, depending on the 
circumstances of the move and the timing of the particular submission. 
Following the move, FDA will publish a notice in the Federal Register 
providing the new address for submissions and identifying the exact 
period during which action on new and existing submissions was 
temporarily deferred.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-84), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-4765, extension 157.

SUPPLEMENTARY INFORMATION: ODE is responsible for many CDRH activities 
under sections 510, 513, 515, and 520 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360, 360c, 360e, and 360j). These 
activities include:
     1. Advising the Director, CDRH, and other FDA officials on all 
medical device submissions, such as premarket notification submissions 
under section 510(k) of the act, device classifications under section 
513 of the act, PMA's and product development protocols (PDP's) under 
section 515 of the act, and clinical investigations under section 520 
of the act;
     2. Determining substantial equivalence for premarket notification 
submissions;
     3. Planning, conducting, and coordinating CDRH actions regarding 
PMA's, PDP's, and IDE approvals, denials, or withdrawals of approval;
     4. Monitoring sponsors' compliance with regulatory requirements; 
and
     5. Conducting a continuing review, surveillance, and medical 
evaluation of the labeling, clinical experience, and required reports 
submitted by sponsors holding approved applications.
    FDA is moving ODE and other CDRH offices from their present 
Rockville, MD location to another facility in Rockville, MD. This move 
will occur in October 1994. Because the move affects ODE's Document 
Mail Center and most ODE review staff, the office's capacity to conduct 
reviews of submissions will be substantially reduced until the move is 
completed. Therefore, the statutory review period for new and existing 
submissions affected by the move will be adjusted accordingly.
     FDA anticipates that this period will take 7 calendar days but 
notes that the maximum adjustment for any particular submission may be 
14 days, depending on the circumstances of the move and the timing of 
the submission. The statutory review period on submissions pending when 
the move begins will be suspended during the relocation period. During 
this period, FDA will continue to accept mail, but will not officially 
log it in until the relocation is completed. When ODE functions resume, 
submissions received during and immediately following the move will 
then be officially logged in, but on a staggered basis to preserve 
equity in the order of receipt and manageability of the accumulated 
workload. Statutory review periods will begin when submissions are 
officially logged in. ODE will of course attempt to minimize the period 
during which regular procedures are suspended. Following the move, FDA 
will publish a notice providing the new address for submissions and 
identifying the exact period during which action on new and existing 
submissions was temporarily deferred.
     Persons who may be affected by this temporary deferment should 
contact FDA with any questions they may have regarding ODE's move to 
the Rockville, MD location. These persons should call CDRH's Division 
of Small Manufacturers Assistance at 800-638-2041, or 301-443-6597 (in 
MD).

    Dated: October 7, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-25517 Filed 10-13-94; 8:45 am]
BILLING CODE 4160-01-F