UCSF PDC Members

This group is a collection of all registered users. You can find general updates and other PDC news within this group.

Comments Requested on FDA Guidance Document Re: Providing Information about Pediatric Uses of Medical Devices

Submission deadline: February 3, 2017

The FDA invites public comments regarding "Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act." This guidance document requires submitters of certain medical device applications, including HDEs and PMAs, to include readily available information about pediatric subpopulations that suffer from the disease or condition that the device is intended to treat. The information will help FDA identify pediatric uses of devices outside their approved or proposed indication for use, as well as areas where further pediatric device development could be useful.

The guidance document can be found here: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm339162.htm

The specific topics identified for public comment are:

1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility
2) The accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used
3) Ways to enhance the quality, utility, and clarity of the information to be collected
4) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information

Details and instructions: https://www.gpo.gov/fdsys/pkg/FR-2016-12-05/html/2016-29105.htm 

Pediatric Medical Device Symposium in Germany

The University of Lubeck is holding a symposium on pediatric medical device development in Europe on December 2, 2016 in Lubeck, Germany. The program will cover clinical needs in pediatric medicine, the situation in low/middle income countries, the manufacturers’ views, and regulatory affairs.

It will be the first conference held on this topic in Germany, and probably the first in Europe. Their goal is to foster exchange between clinicians, developers, support groups and industry, and to form an interest group to improve the development of pediatric medical devices. Anyone from the PDC community would be warmly welcomed to attend!

PedMedDev-2016 (2).pdf538.19 KB

First Mile Innovation Challenge - $25k for Innovations in Global Primary Care

Deadline for Letter of Intent Submissions: January 10, 2017

The Consortium for Affordable Medical Technologies (CAMTech) and GE Sustainable Healthcare Solutions announce the First Mile Innovation Challenge to crowdsource innovative technologies and solutions that address clinical hardships in global primary care. Innovations should impact primary care needs in low- and middle-income countries (LMICs) in the areas of maternal, newborn and child health, cardiac health, and safe surgery. Winners will receive $25,000 in funding, introductions to GE’s five.eight Accelerator, and resources through the CAMTech Innovation Platform.

LOIs should detail: primary care challenge/unmet need being addressed, clinical setting relevant to the challenge and solution, proposed technology/system/process innovation, and a brief summary of the management/development team expertise.

Details and instructions: http://www.globalhealthmgh.org/camtech/wp-content/uploads/2016/11/First-Mile-Innovation-Challenge-RFP-FINAL-1.pdf

First Mile Innovation Challenge Flyer (2).pdf593.75 KB