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U.S. Department of Health and Human Services

Medical Devices

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510(k) Implementation: Discussion of an On-line Repository of Medical Device Labeling, and of Making Device Photographs Available in a Public Database Without Disclosing Proprietary Information, April 7, 2011


Date, Time, and Location

The meeting was held on April 7th, 2011 from 8:30 a.m. to 5:00 p.m., at:

FDA White Oak Campus
10903 New Hampshire Ave
The Great Room (Room 1503), White Oak Conference Center, Bldg 31
Silver Spring, MD, 20903

This meeting was not webcast.

Submit written or electronic comments by May 10, 2011.

Submit electronic comments to http://www.regulations.gov.

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Background

CDRH is exploring the development of a searchable medical device labeling repository that would be accessible by the public and provide useful product information to patients and health care practitioners. This might be similar to the labeling repository specific to drugs that is already available through DailyMed on the National Library of Medicine's website. The repository could eventually cover all classes of devices and could facilitate patient access to information on what types of devices are available for their medical condition and how the devices could be used. It could also assist health care professionals to access labeling that may not always accompany a medical device. FDA also anticipates benefits for device manufacturers, including improved information about potential predicate devices. The labeling available in the repository might cover specific highlighted areas such as indications for use, operational instructions, warning and precautions, and basic maintenance and cleaning. There might also be a photo of the device and any acceptable accessories. We anticipate that the repository would not include service and technical manuals, nor would it supply any proprietary information. CDRH is holding a public meeting to discuss any comments, concerns or questions the public may have about putting all device labeling onto one Web site and soliciting input from the public on what they would want and need in labeling and how they would want to access it. CDRH is also interested in learning more about how patients, consumers and caregivers acquire and use medical device labeling and is seeking input about the circumstances under which patients, consumers and caregivers receive or should receive risk-benefit information and instructions for use for prescription and over-the-counter devices. In addition, CDRH seeks input on which types of medical devices need patient labeling and what elements that labeling should include. CDRH is also interested in learning what resources, such as guidance or training, the public would like it to provide in order to improve the quality of professional and patient labeling.

The second topic to be discussed during this meeting is that of public access to photographs of cleared medical devices. The CDRH Preliminary Internal Evaluations 510(k) Working Group Report of August 2010, recommended that non-proprietary photos be made available in a public database. In considering how to address this recommendation, CDRH recognizes the sensitivity and potential confidentiality issues with photos that would be made publicly available. Accordingly, CDRH is interested in seeking feedback regarding the implementation of this recommendation, including what guidance is needed to better ensure that this recommendation may be implemented consistently and in a manner that is useful to the public without adverse impact on industry.

Agenda

8:30 Welcome and Introduction (William Maisel, CDRH Deputy Director for Science)

8:45 FDA discusses why we are considering a labeling repository (Mary Brady, CDRH/OCD)

9:25 FDA discusses device photographs for use by consumers and health care providers. (Joyce Whang, CDRH/ODE)

9:40 FDA discusses current guidance for developing the content of medical device labeling. (Laurel Mendelson, CDRH/OCER)

9:55 Enhancing the Quality of Professional and Patient/Caregiver Labeling - (Molly Folette Story, CDRH/ODE)

  • Questions and Comments for CDRH Presenters

10:30 Break

10:45 Demonstration of drug labeling website used by the Center for Drug Evaluation and Research: the NLM Daily Med

  • Questions and Comments on DailyMed Website

11:10 A Health Care Provider Perspective, including a demonstration of Biomedical Research and Education Foundation’s (BREF) device repository.

  • Questions and Comments on a Health Care Provider Perspective

11:35 Industry’s Perspective on Accessing Device Labeling

  • Questions and Comments on an Industry Perspective

12:00 Lunch

1:00 A Consumer/Caregiver Perspective on Accessing Device Labeling

  • Questions and Comments on a Consumer/ Caregiver Perspective

1:25 Public Comment Period

2:25 Break

2:45 Panel Discussion (Moderator – Laurel Mendelson, CDRH/OCER)

  • A panel representing industry, healthcare providers and consumers will discuss questions about medical device labeling and photographs.

4:30 Concluding Remarks by Panel members

4:45 FDA Wrap up and Concluding Remarks (Mary Brady, CDRH/OCD)

Presentations

Transcript

Draft Questions for Panel Discussion

Attached is a list of questions for your consideration. These questions, or similar ones, were addressed during a panel discussion at the public meeting. If you wish to share your comments with us on any or all of these topics, please Submit electronic comments before May 10, 2011 to http://www.regulations.gov

  • What are the best ways to make labeling information available to the public? Discuss options including package inserts, web postings, other?
  • What types of professional/patient/consumer information do you want to see? Professional seminars? Videos? Websites? What is the most effective method of communicating labeling information?
  • What does the term “package insert” mean to you?
  • Should any device be excluded from publicly available labeling?
  • What types of devices need patient/consumer labeling?
  • What is the most important content to be communicated in the labeling for professionals? Patients receiving prescription devices or implants? Consumers selecting over-the-counter devices?
  • Should photographs of medical devices be made available to the public? If so, who will use them? How do you recommend this be implemented? Should there be guidance/guidelines/requirements about this, or should it be strictly voluntary?
  • If manufacturers do submit labeling to us, should they use systems that are already in place, such as the electronic gateway, to submit that labeling, or some other means of providing us with the labeling?

Feedback Questionnaires

These questionnaires were made available to meeting participants. If you would like to provide feedback to the FDA on the subject of medical device labeling, please complete the attached questionnaire appropriate to your role and submit it via the means below:

Submit completed electronic questionnaires to http://www.regulations.gov.

Submit hardcopy questionnaires to the Division of Dockets Management (HFA-305), Food and Drug Administration 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Contact Us

For information regarding logistics, registration and special accommodations, contact:

Susan Monahan
Office of Communication, Education, and Radiation Programs
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue, Bldg. 66
Silver Spring, MD 20993
phone: 301-796-5661
email: Susan.Monahan@fda.hhs.gov

For information regarding the program, contact:

Joyce Siwarski
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66, rm. 5402
Silver Spring, MD 20903
Phone: 301-796-5422
FAX: 301-847-8510
e-mail: Joyce.Siwarski@fda.hhs.gov