[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] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Temporary Deferment of Activities Relating to Medical Device Submissions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- 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