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Medtech Snapshot 727
Originally Published MDDI December 2003
December 1, 2003
3 Min Read
.svg?width=850&auto=webp&quality=95&format=jpg&disable=upscale "Medtech Snapshot")
Originally Published MDDI December 2003
Regulatory
FDA medical device program resources have been reduced in recent years and review performance has begun to decline. User fees provided by MDUFMA are designed to get devices to patients more rapidly and to improve timeliness
and quality of reviews.
Medical device listings by medical specialty code, with percentage of total listings. |
Average review time for original premarket approval (PMA) applications increased from 172 days in 2001 to 213 in 2002. | The total average elapsed time to approval of PMAs decreased to 364 days in 2002 as a result of decreases in non-FDA times. |
During fiscal year 2002, the median time for review of 510(k)
submissions by Accredited Persons was 77 days after initial receipt—29% faster than reviews performed entirely by FDA. In addition, submissions reviewed by Accredited Persons are not subject to FDA user fees, whereas 510(k)s sent directly to FDA were subject to a fee of $2187 in fiscal year 2003.
The increase in the number of 510(k) submissions reviewed by third-party organizations can be attributed to the expansion pilot program that now permits third-party review of approximately 460 Class II devices. | In 2002, the average total elapsed time from third-party receipt was 70 days for nonpilot 510(k)s and 105 days for expansion pilot 510(k)s. Expansion pilot 510(k)s include Class II devices without device-specific guidance that can now be reviewed by Accredited Persons. |
Spending for healthcare increased to $1.4 trillion in 2001. Total public funding growth exceeded private funding growth. An important source of growth was payment increases to Medicare providers. Medicare expenditures increased to $242 billion, financing one-sixth of overall health care costs. The recession and rising unemployment contributed to increased Medicaid enrollment.
Spending by public agencies, such as the Centers for Medicare and Medicaid Services (CMS) and Veterans Health Administration, accounted for more than one-third of the nation's annual healthcare spending in 2001. |
Summary of FDA decisions on 510(k) submissions, 1998–2002. Source: ODE annual report. |
ODE received 4320 original 510(k)s as well as 1780 510(k) supplements. Supplements are responses to hold letters, which restart the 90-day review clock. ODE received 2385 510(k) amendments. These provide additional information while the device is under review. The review clock in not affected. The time it took to review 50% of the 510(k)s fell to 74 days in 2002.
Copyright ©2003 Medical Device & Diagnostic Industry
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