Posted: 10 Mar 2016 04:56 PM PST
By Melisa M. Moonan –
On March 4, 2016, FDA published a Federal Register Notification titled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments” (March 2016 notification). This notification announces the establishment of a docket to receive comments “concerning the service, maintenance, refurbishment, and alteration of medical devices, including endoscopes (Ref. 3), by third-party entities” and to learn “more about the challenges third-party entities face in maintaining or restoring devices to their original or current specifications.” FDA is also asking for assistance in defining certain relevant terms. Despite the specific mention of endoscopes and reference to an Advisory Panel meeting on reprocessing issues, FDA does not intend the docket to address device reprocessing.
After a number of historical initiatives in this area, and essentially no regulation of activities short of remanufacturing since 1998, FDA appears to be going back to the drawing board. The agency states this action was prompted by stakeholder concerns about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities, whether by original equipment manufacturers (OEMs) or by third parties, including health care establishments and humanitarian organizations. In particular, FDA has heard concerns that some third parties may use unqualified persons to perform this work and that the work may not be adequately documented. FDA states that potential public health issues resulting from the named activities may include disabled device safety features, improper or unexpected device operation, and ineffective recalls.
While the concerns focus primarily on third party activities, FDA is also interested in determining whether there are any risks associated with the specified activities when performed by OEMs. FDA also notes that OEMs have requested clarification regarding their responsibilities when third parties have altered their devices, although FDA does not appear to be seeking feedback on this particular issue.
Historical Background
FDA has focused attention on these activities a number of times in the past. In the 1980s, FDA issued Compliance Policy Guide (CPG) 7124.28 on reconditioners and rebuilders (defined as firms that acquire ownership of a used device and restore or refurbish them to their original or current specifications, or new specifications, for purposes of resale). The CPG subjected such activities to most of the general medical device controls of the Food, Drug and Cosmetic Act (FDC Act), including registration and listing, 510(k) notification, good manufacturing practices (GMPs), medical device reporting (MDR), labeling (including requiring the device to be labeled as reconditioned or rebuilt), and for such firms that handled Class II or III devices, inspection.
In the 1990s, FDA considered the issue again when promulgating the Quality System Regulation (QSR), which describes current good manufacturing practices (CGMPs) for medical devices. In 21 C.F.R. § 820.200, FDA required manufacturers to establish and maintain servicing instructions for certain devices and to maintain service records. However, in the preamble to the final rule, the agency explained that although it believed servicers and refurbishers met the definition of a manufacturer, it had decided not to include servicers or refurbishers who were outside the control of the OEM under the definition of “manufacturer[s]” who would be regulated under the QSR. FDA’s reasons included that the agency’s GMP Advisory Committee had “sharply divided views” on the issue. See 61 Fed. Reg. 52602, 52610 (Oct. 7, 1996). Instead, the agency determined that remanufacturers, who were defined in the QSR as “any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use,” would be subject to the QSR as manufacturers, and that servicing and refurbishing would be addressed in a later rulemaking.
In December 1997, FDA issued an advanced notice of proposed rulemaking (1997 ANPR) seeking input on how to define and regulate servicers, refurbishers, and “as is” remarketers. FDA sought comments on proposed definitions for such persons/activities, and whether some or all of the general controls of the FDC Act should apply or be voluntary. The ANPR was never finalized. In December 1998, FDA revoked CPG 7124.28, stating that the CPG no longer represented agency thinking.
The revocation of the CPG and the failure to finalize the 1997 proposed rule left refurbishing, servicing, and similar activities essentially unregulated. FDA’s registration and listing website clearly indicates that refurbishers are not required to register or list with FDA. In addition, FDA’s compliance program guidance manual (CPGM) pertaining to inspection of medical device manufacturers states: “Third party refurbishers, reconditioners, servicers and ‘as is’ resellers of used devices are currently not subject to the requirements of the Quality System regulation.” See CPGM 7382.845 at 17. Manufacturers and third parties have been left with uncertainty in terms of the controls, processing, and labeling necessary to remarket used devices.
Definitions, Questions, and Next Steps
Like the 1997 ANPR, the March 2016 notification again seeks comments on suggested definitions (here for the terms recondition, service, repair, refurbish, remanufacture, and remarket). Reconditioning is now defined in a more limited manner (at most it now may involve refurbishing a device to current specifications), and rebuilding is not defined. Servicing is defined similarly to the 1997 ANPR, i.e., maintenance or repair to return a device to the OEM safety and performance specifications, without change to intended use. The refurbishing definition has been updated since the 1997 ANPR to include the concept of restoring the device to a like new condition and to specifically cover hardware and software updates “that do not change the intended use of the original device.” Remarket is defined as “facilitating the transfer of a previously owned device” by various means; “as is” remarketing is not included in the definitions. Remanufacture is defined as in the QSR.
Unlike the 1997 ANPR, FDA makes no statements regarding potential regulatory approaches. Instead, FDA asks seven questions geared to gathering risk/benefit information, and requests specific examples of issues related to the benefits, risks, and challenges associated with each type of activity when performed by different entities (OEMs and third parties, including hospitals and humanitarian organizations). The questions also address the types of information third parties need to perform these activities properly, and request specific examples of actual problems experienced by users of devices subjected to these activities. None of the questions request information on international government or industry policies and initiatives in this area and any potential for harmonization.
Comments are due May 3, 2016 to Docket FDA-2016-N-0436. FDA also plans to hold a public meeting in 2016 on this topic, and states that the comments will inform the agenda. There is sure to be high interest, and stakeholders should take this opportunity to comment and help shape the agenda as this new initiative to clarify an old and controversial issue moves forward to the public meeting.
On March 4, 2016, FDA published a Federal Register Notification titled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments” (March 2016 notification). This notification announces the establishment of a docket to receive comments “concerning the service, maintenance, refurbishment, and alteration of medical devices, including endoscopes (Ref. 3), by third-party entities” and to learn “more about the challenges third-party entities face in maintaining or restoring devices to their original or current specifications.” FDA is also asking for assistance in defining certain relevant terms. Despite the specific mention of endoscopes and reference to an Advisory Panel meeting on reprocessing issues, FDA does not intend the docket to address device reprocessing.
After a number of historical initiatives in this area, and essentially no regulation of activities short of remanufacturing since 1998, FDA appears to be going back to the drawing board. The agency states this action was prompted by stakeholder concerns about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities, whether by original equipment manufacturers (OEMs) or by third parties, including health care establishments and humanitarian organizations. In particular, FDA has heard concerns that some third parties may use unqualified persons to perform this work and that the work may not be adequately documented. FDA states that potential public health issues resulting from the named activities may include disabled device safety features, improper or unexpected device operation, and ineffective recalls.
While the concerns focus primarily on third party activities, FDA is also interested in determining whether there are any risks associated with the specified activities when performed by OEMs. FDA also notes that OEMs have requested clarification regarding their responsibilities when third parties have altered their devices, although FDA does not appear to be seeking feedback on this particular issue.
Historical Background
FDA has focused attention on these activities a number of times in the past. In the 1980s, FDA issued Compliance Policy Guide (CPG) 7124.28 on reconditioners and rebuilders (defined as firms that acquire ownership of a used device and restore or refurbish them to their original or current specifications, or new specifications, for purposes of resale). The CPG subjected such activities to most of the general medical device controls of the Food, Drug and Cosmetic Act (FDC Act), including registration and listing, 510(k) notification, good manufacturing practices (GMPs), medical device reporting (MDR), labeling (including requiring the device to be labeled as reconditioned or rebuilt), and for such firms that handled Class II or III devices, inspection.
In the 1990s, FDA considered the issue again when promulgating the Quality System Regulation (QSR), which describes current good manufacturing practices (CGMPs) for medical devices. In 21 C.F.R. § 820.200, FDA required manufacturers to establish and maintain servicing instructions for certain devices and to maintain service records. However, in the preamble to the final rule, the agency explained that although it believed servicers and refurbishers met the definition of a manufacturer, it had decided not to include servicers or refurbishers who were outside the control of the OEM under the definition of “manufacturer[s]” who would be regulated under the QSR. FDA’s reasons included that the agency’s GMP Advisory Committee had “sharply divided views” on the issue. See 61 Fed. Reg. 52602, 52610 (Oct. 7, 1996). Instead, the agency determined that remanufacturers, who were defined in the QSR as “any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use,” would be subject to the QSR as manufacturers, and that servicing and refurbishing would be addressed in a later rulemaking.
In December 1997, FDA issued an advanced notice of proposed rulemaking (1997 ANPR) seeking input on how to define and regulate servicers, refurbishers, and “as is” remarketers. FDA sought comments on proposed definitions for such persons/activities, and whether some or all of the general controls of the FDC Act should apply or be voluntary. The ANPR was never finalized. In December 1998, FDA revoked CPG 7124.28, stating that the CPG no longer represented agency thinking.
The revocation of the CPG and the failure to finalize the 1997 proposed rule left refurbishing, servicing, and similar activities essentially unregulated. FDA’s registration and listing website clearly indicates that refurbishers are not required to register or list with FDA. In addition, FDA’s compliance program guidance manual (CPGM) pertaining to inspection of medical device manufacturers states: “Third party refurbishers, reconditioners, servicers and ‘as is’ resellers of used devices are currently not subject to the requirements of the Quality System regulation.” See CPGM 7382.845 at 17. Manufacturers and third parties have been left with uncertainty in terms of the controls, processing, and labeling necessary to remarket used devices.
Definitions, Questions, and Next Steps
Like the 1997 ANPR, the March 2016 notification again seeks comments on suggested definitions (here for the terms recondition, service, repair, refurbish, remanufacture, and remarket). Reconditioning is now defined in a more limited manner (at most it now may involve refurbishing a device to current specifications), and rebuilding is not defined. Servicing is defined similarly to the 1997 ANPR, i.e., maintenance or repair to return a device to the OEM safety and performance specifications, without change to intended use. The refurbishing definition has been updated since the 1997 ANPR to include the concept of restoring the device to a like new condition and to specifically cover hardware and software updates “that do not change the intended use of the original device.” Remarket is defined as “facilitating the transfer of a previously owned device” by various means; “as is” remarketing is not included in the definitions. Remanufacture is defined as in the QSR.
Unlike the 1997 ANPR, FDA makes no statements regarding potential regulatory approaches. Instead, FDA asks seven questions geared to gathering risk/benefit information, and requests specific examples of issues related to the benefits, risks, and challenges associated with each type of activity when performed by different entities (OEMs and third parties, including hospitals and humanitarian organizations). The questions also address the types of information third parties need to perform these activities properly, and request specific examples of actual problems experienced by users of devices subjected to these activities. None of the questions request information on international government or industry policies and initiatives in this area and any potential for harmonization.
Comments are due May 3, 2016 to Docket FDA-2016-N-0436. FDA also plans to hold a public meeting in 2016 on this topic, and states that the comments will inform the agenda. There is sure to be high interest, and stakeholders should take this opportunity to comment and help shape the agenda as this new initiative to clarify an old and controversial issue moves forward to the public meeting.
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