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Regulatory: With New Funding, CDRH Advances its MDUFMA Goals

December 1, 2008

3 Min Read
Regulatory: With New Funding, CDRH Advances its MDUFMA Goals

2008 MEDTECH SNAPSHOT

After several years of upheaval and uncertainty, FDA seems to be on track with reauthorized MDUFMA. For FY 2007, FDA reported that it had met 47 of the 77 quantifiable MDUFMA goals. Of the remaining 30, the agency reports that it is not meeting 14 goals, and that 16 of the goals did not have actions completed as of September 30, 2007.

CDRH's Office of Device Evaluation (ODE) received 9415 major submissions in FY 2006, up 8.3% from 8690 in the previous fiscal year. The ODE 2006–2007 annual report says the increase is primarily due to a jump in the number of premarket approval (PMA) supplements received. In FY 2007, the number of submissions received went down to 9276.

In the next year, the General Accounting Office will study appropriate use of the process under 510(k). The recent criticism of 510(k)s may continue to plague product approvals.

Additional funding of $2.04 billion from the Senate Appropriations Committee enabled the agency to make some much-needed improvements, including the hiring of about 1300 new experts. These include physicians, scientists, investigators, and inspectors. FDA is also using the funds to establish agency offices overseas, including in China, India, Latin America, and Europe.

The product approval processes should continue to improve as the agency revamps its information technology systems and gets new data management tools. Looking forward, electronic filing should help FDA speed decisions in the next few years.

Click images and tables to enlarge:

 


The MDUFMA cohort portion of 510(k) submissions reached a five-year high of 95% of total submissions in FY 2007. —FY 2007 MDUFMA Performance Report to Congress


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Number of 510(k)s received by ODE with a third-party review. Source: Office of Device Evaluation Annual Report FY 2006 and FY 2007.


 


FDA is exceeding MDUFMA performance goals for making a decision on PMAs, panel-track supplements, and premarket reports.
—FY 2007 MDUFMA Performance Report to Congress

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Percentage of MDUFMA performance goals that FDA met per fiscal year. Source: FY 2007 MDUFMA Performance Report to Congress.

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The number of 510(k) submissions in FY 2007 returned to average levels after a spike in FY 2006. In FY 2007, 95% of submissions received a ”substantially equivalent” or “not substantially equivalent” decision within 90 days. Source: FY 2007 MDUFMA Performance Report to Congress.

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Number of medical device listings by medical specialty, with percentage of total listings. Percentages are rounded to the nearest whole number. Source: CDRH Database.

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The number of PMA and panel-track supplements submitted decreased to a five-year low in FY 2007. Additionally, 48 amendments were received in FY 2007 with most (32) applying to the FY 2006 cohort. Source: FY 2007 MDUFMA Performance Report to Congress.

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Average total FDA review days from filing to approval for all original and panel-track supplements. Source: Office of Device Evaluation Annual Report FY 2006 and FY 2007.

Copyright ©2008 Medical Device & Diagnostic Industry

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