New Report Critical of FDA Review Process
10.13.11 Dave FisherA recent report from the Competitive Enterprise Institute found the FDA is overly burdensome for manufacturers when it comes to the Agency’s review of medical devices. Read More
Displaying All Posts of Topic: PMA
Last Night’s Speech
09.09.11 Dave FisherYesterday, President Obama unveiled his plan to jumpstart the economy and get Americans back to work. However, he missed an opportunity to highlight an industry that is vital to that goal. Read More
CDRH Announces Training Program For Reviewers
08.04.11 Dave FisherMedical device manufacturers have expressed concerns that frequent turnover at the FDA’s Center for Devices and Radiological Health (CDRH) negatively impacts the submission of innovative, life-saving technologies. Read More
Congress Holds Medical Device Regulation Hearing
07.20.11 Dave FisherToday, the House Energy and Commerce oversight subcommittee held a hearing to discuss regulatory reform in the medical device industry. Read More
Companies and Investors Look to Launch Products Overseas First
06.09.11 Dave FisherAs discussed in yesterday’s blog, members of Congress from both sides of the aisle are concerned that medical device review processes in the U.S. may lead companies to market innovative technologies in other countries before selling their products here at home. Read More
Congressman Drafting Bill to Overhaul FDA Review Processes
06.08.11 Dave FisherCo-Chairman of the bipartisan House Medical Technology Caucus, Representative Erik Paulsen (R-MN) announced last week that he is drafting a bill to streamline the approval and clearance processes for medical devices. Read More
Congress Holds More FDA and Medical Device Hearings
04.13.11 Dave FisherToday and tomorrow, Congress is holding hearings on the FDA’s processes to clear and approve medical devices. Read More
Study: FDA Premarket Approval Process Misses the Mark
02.15.11 Brian ConnellA study printed in yesterday’s Annals of Internal Medicine criticizes FDA’s 510(k) clearance process. Interestingly, the study actually appears to add evidence to the argument that products approved through the 510(k) process are just as safe–if not safer–than those devices approved through the lengthy PMA process. Read More
Recent Posts
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Safeguarding Access to Medical Imaging for Those Who Can’t Afford to Wait
05.11.12 | Gail Rodriguez -
Patient Access to Medical Imaging
04.25.12 | Gail RodriguezMITA released a report yesterday detailing the troubling impact of insurance coverage denials on patient access to medical imaging procedures. Data gathered by the Patient Advocacy Foundation (PAF) show that denials for patients seeking potentially life-saving medical imaging services have doubled in the past four years. Of even greater concern is the finding that 90 percent of the reversed denials for imaging services were actually covered by patients’ health plans. And on average, PAF’s professional case managers required 15.4 contacts per patient case to resolve the imaging issue, meaning it took on average more than 15 phone calls, letters or emails to determine why the imaging test was being denied coverage. Read More
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The ‘Overdiagnosis’ Myth
04.18.12 | Gail Rodriguez -
Appropriateness Criteria: the Right Scan at the Right Time
04.04.12 | Gail Rodriguez -
MITA Joins Forces with Patient Advocates at Unite2Crush Colon Cancer Rally
04.03.12 | Gail Rodriguez -
Breast Cancer Screening Saves Lives
04.03.12 | Gail Rodriguez -
New Study Confirms Money-Saving Benefits of Coronary CT Angiogram in ER
03.27.12 | Gail Rodriguez -
Lung Cancer Screening Saves Lives
03.21.12 | Gail Rodriguez
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