UCSF PDC Members

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

ASAIO Call for Pediatric Device Presentations

Submission deadline: March 1, 2017

The ASAIO Annual Conference will hold the 2nd Pediatric Device Consortia Consulting Forum in Chicago on June 21. Those who wish to present their novel idea on how to get a pediatric device to market before a panel of members from the FDA Pediatric Device Consortia should submit a proposal of less than two pages by Wednesday, March 1, 2017 to info@asaio.com with subject line “Pediatric Device Consortia Proposal.”

Proposals should include a brief device description, intended use, stage of development, market share, and regulatory pathway. Two proposals will be selected for presentation and will receive a monetary award as well as constructive feedback from experts in the field.

For more information, visit https://asaio.com/annual-conference/pediatric-mechanical-circulatory-support-program/

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!

PreviewAttachmentSize
PedMedDev-2016 (2).pdf538.19 KB