The Food and Drug Administration (FDA) is holding a public workshop entitled “Medical Device Servicing and Remanufacturing Activities.” The intent of this public workshop is to publicly discuss the distinction between medical device servicing and remanufacturing activities to better inform the development of a future draft guidance. In addition, due to expressed interest from members of the medical device servicing and remanufacturing industry, the public workshop is also intended to discuss opportunities for collaboration among medical device servicing and remanufacturing stakeholders.
On May 15, 2018, FDA published on its website a report entitled “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices” (FDA Report on Device Servicing) in accordance with section 710 of the FDA Reauthorization Act of 2017 (FDARA). The FDA Report on Device Servicing discussed the continued quality, safety and effectiveness of servicing of medical devices by original equipment manufacturers and third-party entities. The report was informed by feedback and comments from an open docket and a public workshop held in 2016, among other information. Based on the available information, the FDA stated the current available evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing of medical devices that would justify imposing burdensome regulatory requirements at this time. The FDA Report on Device Servicing also included several actions that FDA intends on pursuing.
Clarifying the difference between servicing and remanufacturing activities is one of the actions outlined in the FDA Report on Device Servicing. As described in that report, FDA intends to publish guidance to assist in differentiating these activities. The discussions at the workshop and comments received in the docket will be considered when developing the draft guidance. This draft guidance is on CDRH’s Fiscal Year 2019 (FY 2019) Program Guidance Development “A-list.”
During the workshop, participants will be discussing specific topics outlined in the white paper linked below.
Date, Time, and Location
This meeting will be held Monday, December 10, 2018, 8:00 a.m. to 5:00 p.m. (EST) and Tuesday, December 11, 2018, 8:00 a.m. to 12:00 p.m. (EST) at the following location:
Hilton Washington DC North Gaithersburg Hotel
620 Perry Parkway
Gaithersburg, MD 20877
Please visit the following website for information on the Hilton Washington DC North Gaithersburg Hotel: https://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-north-gaithersburg-GAIGHHF/index.html.
The general sessions of the meeting will be webcast and the link will be posted after November 26, 2018.
FDA is also releasing a white paper to better inform the development of a future draft guidance that is intended to aid industry and FDA staff in determining whether an activity is servicing or remanufacturing. The concepts presented in this white paper are intended to guide discussions during the upcoming workshop. This document contains FDA’s initial thoughts about guiding principles, a flowchart with accompanying text, a complementary approach for software, considerations for labeling, and examples. This white paper is not draft or final guidance and is not intended to propose or implement policy changes regarding servicing and remanufacturing or the applicable statutory and regulatory requirements for entities conducting these activities. Rather, the intent of this white paper is to facilitate public discussion on the distinction between servicing and remanufacturing.
Agenda will be posted by November 26, 2018.
Registration to Attend the Workshop
If you wish to attend this Workshop, you must register by 4 p.m. on December 3, 2018. This public workshop includes topic-focused breakout sessions consisting of small groups which will require facilitators. All requests to be a group facilitator must be received by the close of online registration. There is no fee to register for the workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited and to facilitate equal stakeholder representation in breakout sessions.
A registration form is available online at: https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm623283.htm
Registrants will receive confirmation when requests for participation have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:15 a.m. The FDA will let registrants know if registration closes before the day of the public workshop.
Please submit comments regarding the white paper and the workshop to https://www.regulations.gov, Docket No. FDA-2018-N-3741 by January 25, 2019. The resulting discussions from the workshop and comments received in the docket will be taken into consideration when developing the draft guidance, as proposed in the FDA Report on Device Servicing.
Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is taken into consideration.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Peggy Roney, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5671, Peggy.Roney@fda.hhs.gov.
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