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MEDICAL DEVICE NEWS
 FDA ISSUES FY2008 MEDICAL DEVICE USER FEE SMALL BUSINESS GUIDANCE
October 17, 2007. Rockville, MD
The FDA finally issued the FY2008 Medical Device User Fee
Small Business Guidance today, much to the relief of small businesses which
desired to submit Section 510(k) Premarket Notifications and take advantage of
the small business discount for FY2008. As of October 1, 2007, the FDA
MDUFMA (Medical Device User Fee Modernisation Act) Website was not accepting
Small Business Decision Numbers from FY2007. "The difference in fees is
significant," according to CRO Group Senior Partner Glen Emelock. A small
business able to substantiate gross receipts or sales of no more than $100
million for the most recent tax year pays a fee of $1,702 per section 510(k)
premarket notification submission. Last year, the threshold was $30
million and the discounted fee was $3,326. To obtain a copy of the
guidance which also includes the application form,
click here.
For more information on how The CRO Group may be of assistance with MDUFMA and
additional fees including establishment registration, for your organisation,
click here.
GHTF
RELEASES PROPOSED GUIDANCE ON STED FOR MEDICAL DEVICES
March 16, 2007. Rockville,
MD. The GHTF released today a proposed guidance
on format and content of STEDs (Summary Technical Documents). STEDs
submissions are recognised by several regulatory agencies and are believed to
save manufacturers both time and regulatory costs vs. that associated with
preparing separate country or region licensing applications. For more
information including how The CRO Group may be of assistance in preparing STEDs
that address the guidance requirements in a cost-effective manner, click here.
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