Medical Devices

Public Workshop - Medical Device Servicing and Remanufacturing Activities, December 10-11, 2018

The Food and Drug Administration (FDA) is announcing the following 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between medical device servicing and remanufacturing activities to better inform the development of a future draft guidance.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 The discussions at the workshop and comments received in the docket will be considered when developing the draft guidance. This draft guidance is on CDRH’s Fiscal Year 2019 (FY 2019) Program Guidance Development “A-list.”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 we 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
(301) 977-8900

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.

Webcast

The general sessions of the meeting will be webcast:

White Paper

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

Day 1

Session

Time

Time of Session (min)

Event

 

7:15

45

Registration

Morning Session

8:00

15

Welcome and opening remarks

8:15

15

-History
-Purpose of workshop, white paper, and future guidance
-Overview of white paper

8:30

30

Introduction: Flowchart, software, and examples

9:00

60

Breakout Session: Flowchart, software, and examples

10:00

15

BREAK

10:15

105

Reconvene: Flowchart, software, and examples

LUNCH

12:00

60

-

Afternoon Session

1:00

15

Introduction: Access to appropriate servicing information, labeling, and other considerations

1:15

60

Breakout Session: Access to appropriate servicing information, labeling, and other considerations

2:15

15

BREAK

2:30

60

Reconvene: Access to appropriate servicing information, labeling, and other considerations

3:30

15

Introduction: Guiding principles

3:45

60

Panel: Guiding principles

4:45

15

Closing remarks

5:00

-

Adjourn

Day 2

Session

Time

Time of Session (min)

Event

 

7:30

30

Registration

Morning Session

8:00

15

Welcome, opening remarks, and goals of the day

8:15

60

Update on collaborative efforts and identification of areas most amenable to collaboration

9:15

15

BREAK

9:30

60

Panel: Opportunities, barriers, and goals of collaboration

10:30

30

BREAK

11:00

45

Proposed next steps

11:45

15

Closing remarks

12:00

-

Adjourn

Registration to Attend the Workshop

In-Person Registration is now closed, but we will be accepting on-site registration as space allows on December 10 & 11, 2018.

Submit Comments

Please submit your 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.

Contact Us

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.

For questions regarding workshop content please contact:

Katelyn R. Bittleman
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66, Rm. 3451
Silver Spring, MD 20993
240-402-1478
Katelyn.Bittleman@fda.hhs.gov

OR

Joshua Silverstein
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66, Rm. 1615
Silver Spring, MD 20993
301-796-5155
Joshua.Silverstein@fda.hhs.gov

Page Last Updated: 12/10/2018
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