FDA Approves Digital Pill

The FDA issued its first approval of a Digital Medicine, ABILIFY MYCITE®, a new innovative treatment option in mental health. Otsuka, with the help of Proteus Inc., developed a sensor as part of the pill that communicates externally to provide confirmation the pill was ingested, along with details about it. This is for serious mental illness and can be monitored by others to ensure required medication is being properly taken/administered. Otsuka’s commercialization approach is to launch in 2018, in collaboration with carefully selected health plans and providers in the United States. You can find out more in the press release at the link provided. Otsuka And Proteus® Announce The First U.S. FDA Approval Of A Digital Medicine System: ABILIFY MYCITE® (aripiprazole tablets with sensor)

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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