jueves, 27 de julio de 2017

FDA Announces Digital Health Innovation Action Plan and Launch of Pre-Cert Pilot Program

FDA Logo
Today the FDA announced the Digital Health Innovation Action Plan and our launch of the Software Precertification Pilot Program.
The Digital Health Innovation Action Plan provides details and timelines for our integrated approach to digital health technology and the implementation of the 21st Century Cures Act. 
We recognize that we need a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical promise, the unique user interface, and industry’s compressed commercial cycle of new product introductions. A new pragmatic approach must recognize the unique characteristics of digital health technology and the marketplace for these tools, so we can continue to promote innovation of high-quality, safe, and effective digital health devices.  The Software Pre-Cert Pilot Program is a key component of this plan.
This voluntary pilot program will enable us to develop a tailored approach toward this technology by looking first at the software developer or digital health technology developer, rather than primarily at the product, as we currently do for traditional medical products. This pilot will help us establish the most appropriate criteria for standing up a firm-based pre-certification program for these new digital health tools.
This pilot is an important first step to help us explore and evaluate elements that might be appropriate for a future precertification program, and we will use the pilot to explore whether and how precertified companies that have demonstrated a culture of quality, patient safety, and organizational excellence could be able to bring certain types of digital health products to market without FDA premarket review or after a more streamlined FDA premarket review.  
The application to participate in the pilot program will open August 1.  Additional information can be found on the Digital Health Webpage
To learn more about the plan and pilot program, join us for a webinar on August 1, 2017. 
WEBINAR: On Tuesday, August 1, 2017, the FDA will host a webinar for industry to discuss and answer questions about this precertification pilot program. FDA employees are welcome to participate in this webinar and may join in listen-only mode. No registration is required.
  •  Date: Tuesday, August 1, 2017
  • Time: 1 – 2:30 PM EST (To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar)
  • To hear the presentation and ask questions:Dial: 800-988-9674, International Callers Dial: 1-773-756-4812; Conference Number: PWXW4874924; Passcode: 2374123
  • To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW4874924&p=2374123&t=c
  • Following the webinar, a transcript and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.
NOTE: The FDA does not provide Continuing Education (CEU) or Certificates of Attendance for webinar attendance.

Food and Drug Administration
Center for Devices and Radiological Health

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