Today the FDA issued draft guidance on the Dissemination of Patient-Specific Information from Devices by Device Manufacturers.
The purpose of this guidance is to clarify that that FDA requirements do not prohibit manufacturers from sharing patient-specific information recorded, stored, processed, retrieved and/or derived from a medical device with the patient who is either treated or diagnosed with that device. FDA understands that patients may seek access to accurate, usable information from medical devices so that they can be more engaged with their healthcare providers in making sound medical decisions.
We welcome your comments and suggestions regarding this draft guidance. On Friday, June 10,, 2016, the notice of availability will publish in the Federal Register under docket number FDA-2016-D-1264, and the comment period will be open for 60 days.
If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 or dice@fda.hhs.gov.
Food and Drug Administration
Center for Devices and Radiological Health
Center for Devices and Radiological Health
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