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This article was originally published in The Gray Sheet

Executive Summary

DEVICE REVIEW "MILESTONE" COMMUNICATION SYSTEM is being developed by FDA's office of device evaluation as a means to communicate the status of pending device submissions to manufacturers, FDA says in a Feb. 1 guidance on telephone communications between ODE staff and manufacturers. The system, which will be developed over the next several months by an inter-office task force within the Center for Devices and Radiological Health, would proactively provide manufacturers with confidential status reports on submissions, including premarket approval applications, PMA supplements and 510(k)s. CDRH is considering the use of electronic communication systems such as "voice mail, MCI E-mail, or other new developments suited to the purpose of keeping manufacturers updated on the status of their submissions," the guidance says. The memorandum indicates that FDA also is considering an agency-wide policy that would "specify the format, content, and timing of public status reports concerning submissions pending before the agency." Under current policy, ODE releases no information on pending submissions to the public. The memorandum's stated purpose is to "enable ODE personnel to use the telephone to request or obtain information necessary in the review of submissions without compromising the integrity of program activities." It modifies an earlier draft of the phone policy that FDA completed in June 1992 but never formally implemented ("The Gray Sheet" June 22, p. 6 and Nov. 2, In Brief). The June draft would have prohibited ODE reviewers from receiving any phone calls requesting status updates. The Feb. 1 policy outlines a method for some communication that will be in effect until the milestone communication program is implemented. According to the memo, ODE staffers may accept status calls on product applications only if the documents have been under review for a period that exceeds the statutory deadline for the type of submission. For example, a call on a 510(k) may be accepted after the file has been in ODE for 90 days. A call on a PMA or PMA supplement may be taken if the file has been in house for over 180 days, and a call on an unfiled PMA will be accepted after the submission has been in ODE for 45 days. The new policy also allows ODE reviewers to obtain clarification of a submission as well as request minor changes to or additions of information by telephone. According to the memo, examples of such changes are "a change in the labeling, a change in the instructions or a change in the 510(k) summary or PMA summary, provided the requested information has been documented in writing and has the concurrence of...[an ODE] supervisor." Manufacturers may confirm details of the request by fax and must submit the requested information in writing to the agency. Any requests where "the deficiencies are complex or require the submission of substantial new information such as a request that would require new clinical studies or new analyses of data and information" must be sent to the manufacturer in writing. Manufacturers may discuss the request with ODE by phone or at a meeting, but answers must also be submitted in writing. The phone policy also informs ODE staff that "any manufacturer who abuses the use of the telephone by attempting to get frequent status information about a submission or by trying to improperly influence the timing or outcome of a review should be reported through supervisory channels. If this type of abuse occurs repeatedly, that manufacturer's telephone access to ODE staff members may be curtailed." The policy notes that some calls on business other than submissions are acceptable, but "there is no requirement upon the part of any ODE staff member to accept or return a call from a manufacturer." The policy advises ODE staff to make written records of phone conversations with manufacturers "regardless of who initiated the call."

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