FDA Defines Its Authority Over Mobile Medical Apps

Margaret Dick Tocknell, for HealthLeaders Media , July 20, 2011
  • Must comply with the quality system regulation to help ensure that products consistently meet applicable requirements and specifications.
  • Must develop requirements for their products that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute their devices.
  • Must comply with adverse event reporting requirements.
  • Must correct problems voluntarily or at the request of the FDA.

The FDA is accepting comments on the 30-page proposed guidelines for 90 days.


Margaret Dick Tocknell is a reporter/editor with HealthLeaders Media.
Twitter
1 | 2 | 3

Comments are moderated. Please be patient.


MOST POPULAR

SPONSORED REPORTS
SPONSORED HEADLINES

SIGN UP

FREE e-Newsletters Join the Council Subscribe to HL magazine

SPONSORSHIP & ADVERTISING

100 Winners Circle Suite 300
Brentwood, TN 37027

800-727-5257

About | Advertise | Terms of Use | Privacy Policy | Reprints/Permissions | Contact
© HealthLeaders Media 2014 a division of BLR All rights reserved.