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FDA's Regulation of Implantable and Wearable Sensors: 2-Day in - Person Seminar

By: ComplianceOnline

United States of America (USA)

06 - 07 Oct, 2016  2 day

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USD 1,999

Sensors have begun to revolutionize human health due to their ability to provide real time health monitoring under a diverse set of conditions. For example, sensors can provide real time information such as heart rate, blood pressure, biomolecular concentrations, glucose levels, motion and exercise data, neural activity, and so much more. While wearable sensors have seen an explosion in use, the reliability of such data collected has been questioned. Moreover, very little has advanced in terms of implantable sensors, yet implantable sensor can provide much more in depth and variety of health data compared to wearable sensors. Implantable sensors also have the capability to reverse adverse health effects, whereas wearable sensors do not.

This tutorial will provide an historical context for the use of wearable as well as implantable sensors in medicine, where the field has been and where it is going. It will also provide a few examples of FDA approved sensors in medicine and what is needed for the field to progress. Currently, there is an ongoing debate in industry on how such sensors should be regulated, in particular by the FDA or under the practice of medicine, under federal law or state law, and as medical devices, drugs or simply biologics.

Learning Objectives:

Upon completing this course participants should have an understanding of:

  • Fundamentals of sensors
  • What is all the excitement about
  • How to build sensors
  • Wearable versus implantable sensors
  • Incorporating cells and/or biological materials into sensors
  • Avoiding immune system clearance of sensors
  • Biological reactions to sensors
  • FDA regulatory approvals for sensors
  • Currently approved sensors in medicine
  • FDA guidance documents for sensors
  • Global approval of sensors
  • How the FDA regulates sensors
  • The medical device, drug and biological approval process
  • Sensors for both diagnostic and therapeutic purposes
  • How to design appropriate clinical trials
  • Applicable good manufacturing and good laboratory practices
  • Product labeling, marketing and advertising
  • FDA and other federal agency enforcement action
  • Future thoughts on approaches for the regulatory approval sensors
  • Remaining hurdles
  • Outlook for new technologies

Who will benefit:

This course is designed for professionals in wearable and implantable sensors such as for researchers, business personnel, start-up companies, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Labelers and private labelers
  • Contract manufacturers
  • Importers and custom agents
  • U.S. agents of foreign corporations
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
  • Record retention specialists
  • Medical affairs
  • Legal professionals
  • Financial advisors and institutional investors
  • Patent lawyers
  • Graduate students
  • Academic faculty and professors
  • Clinicians
  • Entrepreneurs
Boston, MA, USA Oct 06 - 07 Oct, 2016
USD 1,999.00
(Convert Currency)


Note: Use coupon code < NB5SQH8N > and get 10% off on registration.