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REGULATORY 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.
FDA POSTPONES 2008 ESTABLISHMENT REGISTRATIONS
Rockville, MD USA 19 June 2007.
The FDA announced it was postponing 2008 establishment
registration activities for all medical device manufacturers until "October or
November, 2007". If your company is already registered for 2007, then the
registration will remain valid until December 31, 2007. FDA said it was
taking this action because "upcoming changes" are in the works including:
electronic (via the Internet) registration, implementation of the Bioterrorism
Act, which will require foreign registrants to declare each of the importers of
their products, and changes being considered by Congress. For more
information on the postponement,
click here.
The CRO Group is a US Agent and Official Correspondent for a host of foreign
firms. For more information on CRO Group services,
click here.
FDA PROPOSES
REINSPECTION FEES
Washington, DC USA 16 February 2006. Testifying
before Congress, Acting FDA Commissioner Andrew von Eschenbach, as part of the
FDA FY 2007 budget, proposed to have manufacturers who fail their FDA
inspection pay the full cost of re-inspection as well as "other FDA follow-up
work."
According to Dr. von Eschenbach, the reinspection user fee
will "ensure that facilities that fail to
comply with established health and safety standards
bear the cost of FDA follow-up inspection. We are asking Congress to assess
the cost of follow-up inspections on those who fail to comply, rather
than on the American taxpayer, who bears the cost
today. The natural consequence of this change will be that
manufacturers will work to ensure that they meet established standards."
If this budget is approved,
FDA estimates that approximately $22 million allocated for reinspections will be
paid for by manufacturers. The estimated cost of a reinspection was not
addressed in the testimony, however, with 1,270 FDA reinspections in 2005, this
brings the average cost to over $17,000. To read the transcript of the
testimony,
click here. For more information on CRO Group FDA inspection related
services, including conducting mock FDA inspections, as well as dealing with
483's click here.
You can stay
ahead of these
changes in the USA, EU, Canada, and virtually everywhere on
the planet by subscribing to StdsRadar. For a no obligation quote,
contact
us at
stdsradar@crogroup.com.
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