Posted: 11 Dec 2014 12:14 PM PST
By Jeffrey N. Gibbs & Allyson B. Mullen –
A new article published on Medical Device and Diagnostic Industry’s (MDDI) website by Hyman, Phelps & McNamara, P.C.’sJeff Gibbs, Allyson Mullen, and Graematter, Inc’s Melissa Walker, shows that there is more to 510(k) review time statistics than the statistics that FDA publishes. (A shorter version of the full length article will also appear in MDDI’s magazine in early 2015.) The authors analyzed 510(k) review time data from FDA’s publicly available database using SOFIE, Graematter Inc.’s Regulatory Intelligence System. The article points out several interesting conclusions from the analysis:
A new article published on Medical Device and Diagnostic Industry’s (MDDI) website by Hyman, Phelps & McNamara, P.C.’sJeff Gibbs, Allyson Mullen, and Graematter, Inc’s Melissa Walker, shows that there is more to 510(k) review time statistics than the statistics that FDA publishes. (A shorter version of the full length article will also appear in MDDI’s magazine in early 2015.) The authors analyzed 510(k) review time data from FDA’s publicly available database using SOFIE, Graematter Inc.’s Regulatory Intelligence System. The article points out several interesting conclusions from the analysis:
- Use of the third-party review program has significantly declined, while the review times for these 510(k)s have increased.
- Contrary to expectations, there is no review-time advantage to submitting an Abbreviated 510(k) compared to a Traditional 510(k).
- Analyzing review times for specific device types can show surprising patterns. Even those devices most frequently reviewed by FDA still saw an increase in their overall review times between 2008 and 2012.
- There can be substantial jumps in average review times for certain types of products; steep declines are rarer.
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