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

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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 ™ …

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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.

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

How to enhance your medical device approval process

Thursday, December 29th, 2011 | Permalink

But are relationships important when it comes to getting medical devices approved through the FDA? Beyond relationships, what else matters when it comes to improving the medical device regulatory process? In this interview with Sheila Hemeon-Heyer, President of Heyer Regulatory Solutions, we learn where medical device companies are missing the mark when it comes to the FDA approval process. Prior to … Comments RSS Post a comment. No comments yet.

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How to enhance your medical device approval process

New Legislation Seeks to Improve Advisory Panels, Remove Barriers to Innovation

Tuesday, November 22nd, 2011 | Permalink

Tue, 11/15/2011 FDA   A new piece of legislation was introduced in the Senate this week to help speed up the approval and clearance of medical devices. The legislation, “Patient Access to Medical Innovation Act”, was introduced by Senator Al Franken (MN), who noted “My legislation would remove unnecessary barriers so that these critical medical devices get to the patients that need them as quickly and safely as possible.”   read more

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New Legislation Seeks to Improve Advisory Panels, Remove Barriers to Innovation