Posts Tagged fda

Congressional Letter Urges FDA to Improve Med Tech Pathway

Monday, January 30th, 2012 | Permalink

Congressional Letter Urges FDA to Improve Med Tech Pathway

11/08/2011

A bipartisan, bicameral letter was sent to FDA Commissioner Margaret Hamburg recently urging her to improve the agency’s handling of medical technologies. “Unless we make significant improvements to the predictability and transparency of the regulatory process, we will lose the industry, the jobs that go with it, and the innovation to transform our healthcare system,” stated the letter.

The signers are asking FDA to:

  • Recognize and correct the disparity between “FDA time” versus real time when tracking device approvals;
  • Consider potential benefits of harmonization with international testing standards;
  • Address the unintended consequences of the conflict of interest rules for advisory panels; and,
  • Create a transparent tracking and review system for applications and clearance decisions.

A hearing will be held in the U.S. Senate next week taking a closer look at efforts FDA is working on to improve the regulatory environment,  and examining the impact that today’s challenges are having on patient care and innovation.

http://www.medicaldevices.org/node/1118

~ QD Syringe Systems

See the original post:
Congressional Letter Urges FDA to Improve Med Tech Pathway

Congressional Letter Urges FDA to Improve … – QD Syringe Systems

Monday, January 30th, 2012 | Permalink

Filed under: Syringe Blog | Tags: fda, medical device approvals, medical device regulation, qd, qd syringe systems , qdss, us senate | … http ://www.medicaldevices.org/node/1118 … RSS . RSS Feed for QD Syringe Systems ™ …

Original post:
Congressional Letter Urges FDA to Improve … – QD Syringe Systems

Potential of male urinary incontinence treatment in U.S. could be …

Monday, January 2nd, 2012 | Permalink

Uromedica, which develops urinary incontinence treatments, will find out in as soon as a few weeks if its medical device for men is ready for U.S. Food and Drug Administration approval application. The Minnesota medical device company submitted fresh data to the FDA that, if accepted, would be the basis for a premarket approval (PMA) application, CEO Tim Cook said. Uromedica sent the data, which included a … Comments RSS Post a comment. No comments yet.

Read the original:
Potential of male urinary incontinence treatment in U.S. could be …

Contact Us

Click or drag a file to this area to upload.