[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
