MD Expo Panel on FDA Docket Draws a Crowd
MD Expo Dallas was the place to be for HTM professionals. The biannual event included continuing education sessions, a packed exhibit hall, networking events and panel discussions.
One of the popular panel discussions was the for “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments.” MD Expo continues to empower the biomedical/CE professional with industry-leading incentives. This panel discussion served as another example of that effort.
Experts from throughout the industry shared their insights during the MD Expo panel discussion. It was an educational and thought-provoking event. Attendees are reminded to submit their comments by the FDA’s new extended deadline of June 3. The deadline was extended to June 3 “due to the unanticipated high level of interest from interested persons,” according to a notice posted in the Federal Register.
Confidential Submissions
To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Written/Paper Submissions
Submit written/paper submissions as follows:
- Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
- For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2016-N-0436 for “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
The FDA announced on March 4 that it was gathering information. The FDA asked stakeholders to provide information in response to seven specific questions and input on six definitions.
The questions are:
- Who are the different stakeholders involved with the medical device activities listed previously? What are their respective roles?
- What evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities? Specific examples should be provided.
- What are the potential risks to patients or users and the failure modes introduced as a result of performing the previously defined activities?
- These activities are performed by OEMs and various third-party entities, including hospitals and humanitarian organizations. Are the risks different depending on who performs them?
- Are these activities more difficult or riskier to perform on certain devices than others?
- What information do third-party entities need in order to perform these activities in a way that results in the safe and effective operation of the medical device?
- What additional challenges do stakeholders encounter with devices that result from these activities?
A recent article in Medical Dealer magazine discusses this issue more.
For additional information, visit https://www.federalregister.gov/articles/2016/03/04/2016-04700/refurbishing-reconditioning-rebuilding-remarketing-remanufacturing-and-servicing-of-medical-devices.
