Updates
Guidance Documents - Request for Comment
Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
FDA has developed this draft guidance for labelers of class I devices to revise “Section III. Policy On Standard Date Formatting, UDI Labeling, and GUDID Submission Requirements for Class I and Unclassified Devices” of the guidance Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking, (“2020 UDI Compliance Policy Guidance”) that was issued on July 1, 2020. When this draft guidance is finalized, the updates in Section III of this draft guidance would supersede the recommendations in Section III of the 2020 UDI Compliance Policy Guidance. This draft guidance explains that there are certain class I devices for which FDA does not intend to enforce Global Unique Device Identification Database (GUDID) submission requirements under 21 CFR 830.300, and describes how a labeler of a class I device can determine whether its device is within the scope of this compliance policy.
Consumer Updates
Hearing Aids and Personal Sound Amplification Products: What to Know
 Learn about hearing aids, personal sound amplification products, and the proposed change to how you can get hearing aids.
Are you or a loved one having a hard time hearing? Perhaps you’re thinking about getting a hearing aid.
Hearing aid technology keeps evolving, which means there’s a growing variety of styles and features to consider.
“People who already use a hearing aid know that selecting one is not a simple decision,” says Eric Mann, M.D., Ph.D., chief medical officer in the FDA office responsible for hearing aids. “Hearing loss affects people in different ways. So, it’s important to choose a hearing aid that’s appropriate for your condition and fits your lifestyle.”
The U.S. Food and Drug Administration regulates hearing aids to make sure they are safe and effective. If you’re considering hearing aids, this article highlights some common technologies and terms you may encounter and notes a change that’s coming to how hearing aids are sold.
Biosimilar and Interchangeable Biologics: More Treatment Choices
 The U.S. Food and Drug Administration has approved biosimilar medications to treat conditions such as cancer, diabetes, Crohn’s disease, colitis, rheumatoid arthritis, psoriasis, and more.
But what are biosimilar and interchangeable biosimilar biological medications? To answer that question, it helps to first know what biological products (biologics) are.
FDA Voices
How CDRH’s Digital Transformation Initiative Will Strengthen the Premarket Review Program
 By: Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and William Maisel, M.D., MPH, Director, Office of Product Evaluation and Quality (OPEQ), CDRH
At the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), we are committed to protecting the public health by ensuring patients have more timely access to safe, effective, and high-quality medical devices. This includes our responsibility to review premarket submissions for certain new medical devices and modifications to devices currently on the market. As part of this ongoing work, the FDA continues to take steps to strengthen the premarket review program and make it more efficient, consistent, and predictable.
ICYMI!
Stakeholder Call on Sodium Reduction
 On October 13, 2021 FDA hosted a stakeholder call to discuss the release of the Sodium Reduction Final Guidance. Dr. Janet Woodcock, FDA Acting Commissioner, and Dr. Susan Mayne, Director, Center for Food Safety and Applied Nutrition, gave opening remarks and answered questions from the audience. Dr. Robin McKinnon, Senior Advisor for Nutrition Policy, and Ms. Kasey Heintz, Nutrition Scientist from CFSAN also participated on the call.
Cannabis-Derived Products Data Acceleration Plan
 By Antoinette Coleman, Presidential Innovation Fellow, Office of the Commissioner (OC) and April Alexandrow, PhD., Science and Policy Coordinator, Cannabis Product Committee, Office of the Commissioner (OC)
On October 19, 2021, FDA launched the Cannabis-Derived Products Data Acceleration Plan (DAP). The DAP is a portfolio of pilot initiatives and partnerships focused on advancing data-driven safety signal detection and building advanced technology capabilities. The DAP’s primary goal is to leverage novel data sources and advanced data analytics to identify current and emerging safety vulnerabilities in the CDP market. The DAP is also focused on forging government data partnerships and championing scientific research to evaluate safety and consumer vulnerabilities.
Webinars and Virtual Workshops
Pharmaceutical Quality Symposium 2021: Innovations in a Changing World
The symposium will address the latest developments in pharmaceutical quality and highlight ways in which innovations have been embraced in a changing world.
October 26 - 27, 2021
Day 1: 9:00 AM - 4:00 PM ET
Day 2: 8:45 AM - 3:15 PM ET
Public Meeting on the Recommendations for Biosimilar User Fee Act (BsUFA) Reauthorization
FDA will hold a virtual public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027 (“BsUFA III”). BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological product applications. Requests to make a verbal comment at the meeting must be received by October 26, 2021.
November 2, 2021; 9:00 AM - 12:00 PM ET
FDA Virtual Public Meeting on Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act
This meeting will provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to provide input to FDA on the implementation of the enhanced drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) that go into effect in 2023.
November 16, 2021; 9:00 AM - 4:00 PM ET
Closer to Zero Action Plan: Impacts of Toxic Element Exposure and Nutrition at Different Crucial Developmental Stages
This meeting is the first of several expected meetings on the Closer to Zero (C2Z) action plan to receive stakeholder input. The purpose of this meeting is to discuss the scope of our action plan as it relates to the impacts of toxic element exposure and nutrition at different crucial developmental stages on growth and development.
November 18, 2021; 10:00 AM - 4:00 PM ET
Best Practices for Development and Application of Disease Progression Models
The purpose of this public workshop is to discuss the best practices for developing disease progression models and their application to support drug development decisions, share experiences and case studies that highlight the opportunities and limitations in the development and application of disease progression models including models for natural history of disease and clinical trial simulations, and discuss the knowledge gaps and research needed to advance the development and use of disease progression models.
November 19, 2021; 9:30 AM - 2:30 PM ET
About Us
The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations.
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