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510(k) STATUS REPORT SYSTEM IS BEGINNING OPERATION ON JUNE 28

This article was originally published in The Gray Sheet

Executive Summary

510(k) STATUS REPORT SYSTEM IS BEGINNING OPERATION ON JUNE 28, according to FDA. "Device manufacturers have clearly expressed a desire to have more information on the status of their 510(k) submissions as they proceed through the review process," Center for Devices and Radiological Health Director Bruce Burlington says in a letter that CDRH plans to send to manufacturers on June 30. "To address this, CDRH has established a 510(k) status reporting system through which manufacturers may receive a status report on their 510(k) submissions, usually within three days of requesting it." FDA developed the system because it has had problems responding to sponsor inquiries on device submissions ("The Gray Sheet" May 31, p. 1). The system will be in effect until the device center implements an automated electronic program, plans for which were outlined in a communications policy document in February ("The Gray Sheet" Feb. 8, p. 7). The interim system deals only with 510(k)s because this is the area of most concern to industry, FDA says; the permanent system, when implemented, will handle inquiries on all types of applications. As anticipated, the communication system is being operated by the division of small manufacturers assistance in CDRH's office of training and assistance. Under the interim program, manufacturers will be able to submit inquiries to DSMA 90 days after FDA receives the 510(k) and will only be allowed to submit one request per 510(k) every four weeks. Requests may be made via facsimile or mail, but not by telephone. Facsimile requests may be sent to DSMA at (301) 443-8818. CDRH's letter to manufacturers includes a suggested format for submission of 510(k) status inquiries. The requests should include: the sponsor's name and mailing address the requester's name, affiliation with sponsor, mailing address, facsimile number (if applicable), telephone number, and signature and 510(k) information, "including product name, 510(k) number, date logged in by [the office of device evaluation] and name of contact person," according to the letter. Telephone requests cannot be accepted because of "staff limitations," CDRH notes. The new system will provide manufacturers with information on which ODE branch a 510(k) has been assigned to, the most recent action that CDRH has taken on a 510(k), and the position of the 510(k) in the reviewer's queue. The device center also is "working towards being able to provide [sponsors] with average review times for 510(k) submissions" and expects "to add this to our routine response soon," according to the letter. CDRH cautions that "there are some situations which may adversely change a manufacturer's position in a [review] queue in ways that are not readily apparent." For example, 510(k)s "that fit our criteria for 'expedited review' will go to the top of reviewers' queues," which would change the position of other submissions. Another situation that will affect a 510(k)'s position is when ODE issues a deficiency letter to the sponsor. "This will cause the 510(k) to go to bottom of the reviewer's queue," the letter says. Finally, there are cases when "staffing changes will result in combining or splitting queues," which could also affect a submission's position. The new policy should bring greater efficiency to the review process because ODE reviewers will not have to spend time responding to inquiries. "Because we have committed our resources to this system, ODE will no longer be able to respond to telephone calls requesting information about the status of 510(k)s," CDRH remarks. FDA plans formally to announce the new policy at a medical devices advisory committee chair-persons meeting in Rockville, Maryland on June 30. Several other device evaluation initiatives that have been in development also will be announced at the June 30 panel meeting. For example, CDRH's plans for prioritizing its review of 510(k)s and expanding its expedited review policy will be unveiled. FDAers discussed plans for the 510(k) "triage" in March ("The Gray Sheet" March 15, p. 3) and in May revealed plans for speeding review of breakthrough devices. The recently implemented 510(k) checklist also will be discussed at the meeting, FDA says. CDRH's device evaluation division of reproductive, abdominal, ear, nose, throat, and radiological devices began screening 510(k)s with the checklist on June 15 ("The Gray Sheet" June 21, p. 16). Use of the checklist likely will be expanded to other office of device evaluation divisions after a 30-day pilot of the policy, according to FDAers.
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