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510(k) DEVICE MODIFICATION GUIDANCE

This article was originally published in The Gray Sheet

Executive Summary

510(k) DEVICE MODIFICATION GUIDANCE will allow manufacturers to continue marketing changed devices prior to 510(k) clearance in cases where the modification was made as the result of a recall, according to Ronald Johnson, director of the device center's office of compliance and surveillance. Announcing plans for the guidance March 2 at a Health Industry Manufacturers Association meeting in Washington, D.C., Johnson said that document will provide "some mechanisms that will allow, for example, when you make a retrofit for a recall, that you can make that same retrofit for new production without having to wait whatever period of time a 510(k) needs to get through the system." In addition to outlining when marketing can continue, the guidance document will define the types of changes requiring submission of a 510(k). The guidance is aiming to clarify what is seen as vague regulatory language on the issue. FDA regs require submission of 510(k)s for device modifications that "significantly affect the safety or effectiveness of the device." Because of the difficulty in writing specific guidance on the numerous potential device modifications, the device center may supplement the guidance with a "question and answer" document that includes examples of how different types of modifications should be handled. With the new initiative to develop a device modification 510(k) guidance, the Center for Devices and Radiological Health is returning to an issue it grappled with but never resolved in the 1980s when similar projects were undertaken. CDRH staffers say the new guidance has high priority and that a draft may be available in several months. One likely reason for the device center's renewed interest in the document is the increased number of citations being made by FDA inspectors for lack of 510(k) clearance of device changes. Robert Sheridan, former director of CDRH's office of device evaluation and currently a consultant at C.L. McIntosh, commented that the issue "is going to come to a head very soon" because "more and more citations which assert that the company has made [device] modifications which need a new 510(k)" are appearing in warning letters. The Medical Device Manufacturers Association criticized the trend in a recent letter to FDA ("The Gray Sheet" Feb. 22, p. 8). The device center recently reigned in field staff authority in this area, requiring that all such warning letter citations be cleared by CDRH. The device modifications 510(k) guidance is one of several efforts under way at OCS that were discussed by FDAers at HIMA conferences on March 1 and March 2. The issue of uniform field enforcement practices also was addressed. At the March 1 meeting, Johnson commented on an ongoing "audit" of warning letters issued by the field to ensure citations and issuance were appropriate. The preliminary audit information "looks pretty good...it does not look like there is inconsistency, it does not look like [inspectors] are going crazy as some of you feared," Johnson reported. In a March 2 session, Gary Dykstra, deputy associate commissioner for regulatory affairs, pointed to the "incredible amount of time" FDA has spent meeting with senior field staff during the past year to help ensure that uniform criteria are used in writing and issuing FD-483s and warning letters. OCS also is playing a part in CDRH's effort to improve communications with the device industry. Johnson said he plans to send a second letter to manufacturers "in a month or so" to discuss OCS activities. An initial letter sent in January, which focused on OCS' "reference list," was well-received by the device industry as a step towards improved communications with CDRH. One issue that will be addressed in the coming letter is the backlog of export certificates at OCS ("The Gray Sheet" Nov. 30, p. 8). The backlog currently stands at "about 500" pending requests, according to Johnson. Johnson said he hopes to report in the letter that "we have no backlog of export certificates, and that we are able to process export certificates in a very rapid fashion." OCS is streamlining review of the certificates, Johnson noted. Other OCS activities include a recent initiative to identify and inspect companies with chronic device recall problems. When a manufacturer is identified, OCS conducts "a rather extensive review" of its experience with the firm, including the inspectional history and reasons for recalls and MDR reports, Johnson explained. OCS then develops an enforcement strategy for the company and provides it to the field to "focus the field office's inspection on specific areas that we think may be contributing to the production of defective products." OCS has completed reviews of the ten companies with the most recalls and is "moving down the list," according to Johnson. The enforcement office also is "deeply involved with" investigations of companies that display a pattern of noncompliance at numerous facilities, Johnson said. He explained that the program is aimed at determining "if there is something happening in this common management, common ownership that is responsible for the problems that we are seeing" at different facilities. Johnson added that as part of this "corporate policy," "five or six" companies currently are under investigation and that OCS is "very close to coming to resolution" on one case in the form of a legal agreement. At the March 1 conference, Walter Gundaker, an industry consultant at C.L. McIntosh and former CDRH director, criticized the corporate policy as a "coordinated attack" that places "a terrible burden on any firm" by conducting simultaneous investigations at different facilities. OCS also is targeting companies based on the type of device being manufactured. "We have found that certain products...seem to have more problems than other devices, so what we have done is designed programs that essentially take a look at everybody that is involved in that product development and manufacturing," Johnson explained. OCS is assessing manufacturers of intraocular lenses, therapy planning systems, defibrillators, and several other types of devices, according to Johnson.
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