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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPatient Engagement Advisory Committee

Meeting Date: 10/22/20-10/22/20

Meeting Details:

On October 22, 2020, the committee will discuss and make recommendations on the topic “Artificial Intelligence (AI) and Machine Learning (ML) in Medical Devices.” Specifically, we will discuss the composition of the datasets on which the software “learns”, components of the device information shared with patients, and factors that impact patient trust in the technology. Large clinical datasets are used to train and improve AI/ML algorithms, allowing transformational improvements in the diagnosis, clinical decision making, and treatment of patients. Devices using AI/ML technology will transform healthcare delivery by increasing efficiency of key processes in the treatment of patients. Health products powered by AI/ML are streaming into our lives, from virtual doctor apps to wearable sensors and drugstore chatbots to algorithms for detecting cancer in mammography and interpretations of chest X rays. Despite the rapid advancement and integration, AI/ML systems may have algorithmic biases, limited generalizability, and lack transparency in their assumptions based on potential limitations of training datasets. The recommendations provided by the committee will address the importance of including various demographic groups in AI/ML algorithm development. The recommendations will also address the impact of the user interface and transparency including what information and how the information about the devices could be communicated to foster patient trust in the AI/ML devices.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:00AM-5:00PM    
Materials:
   
       

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Upcoming Meetings

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue, and Gene Therapies AdComm

Meeting Date: 4/15/21-4/15/21

Meeting Details:

The Committee will meet in open session to discuss biologics license application (BLA) 125734 for donislecel (purified allogeneic deceased donor pancreas derived Islets of Langerhans). The applicant, CellTrans, Inc., has requested an indication for the “treatment of brittle Type 1 diabetes mellitus (T1D).” The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the MDAC
Sponsor: TransMedics, Inc

Meeting Date: 4/6/21-4/6/21

Meeting Details:

The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the TransMedics Organ Care System (OCS) Heart, by TransMedics, Inc. The proposed Indication for Use for the TransMedics OCS Heart, is as follows: The TransMedics Organ Care System (OCS) Heart System is a portable extracorporeal heart perfusion and monitoring system indicated for the resuscitation, preservation, and assessment of donor hearts in a near-physiologic, normothermic, and beating state intended for a potential transplant recipient. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. Related News Links: Not Available
Time: 9:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Arthritis Advisory Committee and the DSaRM

Meeting Date: 3/24/21-3/25/21

Meeting Details:

The committees will discuss biologics license application (BLA) 761130, tanezumab subcutaneous injection, submitted by Pfizer Inc., for the proposed indication of relief of signs and symptoms of moderate to severe osteoarthritis in adult patients for whom use of other analgesics is ineffective or not appropriate. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 9:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel of the MDAC

Meeting Date: 3/23/21-3/23/21

Meeting Details:

The committee will discuss and make recommendations regarding the benefits and risks of dermal fillers concerning the following topics: (1) risks associated with intravascular injection of dermal fillers and (2) patient preference and informed decision making. FDA is convening this meeting to seek expert opinion on the clinical evaluation and regulation of dermal filler products. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 9:00AM-6:00PM    
Materials:
   
       

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Past Meetings

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