Few Words About Us |
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IRC was founded in 2004 by Charlie Mack and Elvis Ge.
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Charlie Mack worked at UL as a qualified 510(k)
reviewer. Trained engineers for Third Party review for
Biocompatability, sterility, software, test documentation,
validation and procedures. Has worked with numerous clients in
resolving technical issues to ensure FDA and Safety Compliance.
Qualified by Cameron Quality assoicated for IEC 61950, IEC 61010 and
IEC 60601-1. Has conducted seminars to assist clients in
understanding the Medical Device regulations.
Elvis Ge has worked for Minolta as a
QA Manager,Draeger as a Management Representative, UL as a Senior
Account Manager and IRC as the Operations Manager.
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What We Do |
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We assist in international development and marketing of
medical devices is a highly regulated process that requires
expert level navigation to prevent bottlenecks and minimize
risk. IRC specializes in providing this advanced
regulatory consulting expertise to the Medical Device industry.
We have many satisfied customers in the medical device industry
FDA 510(k) Shift |
• January 2011
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The Food and Drug Administration's (FDA's) Center for Devices
and Radiological Health (CDRH) today announced its plan of action
for implementation of its 510(k) and science recommendations. The
plan of action represents a scaling back of the extensive
recommendations the agency issued in August 2010, but is
confirmation of FDA's continued commitment to the 510(k) pathway.
Some potentially significant actions remain, including, for
example, implementation of a pilot program to explore the use of
an assurance case framework for 510(k) submissions. The
implementation plan includes 25 specific actions and time lines
for 2011, with seven additional actions pending review and
consideration by the Institute of Medicine (IOM), whose report is
expected to be issued in the summer of 2011.
- Pursuit of a statutory amendment for FDA to consider
off-label use when determining the "intended use" of a device
- Establishment of a Class IIb that would require additional
clinical information, manufacturing information, or
postmarketing evaluation for a determination of substantial
equivalence
- Definition of the scope and grounds for FDA to fully or
partially rescind a 510(k) clearance
- Clarification of when a device should no longer be available
for use as a predicate
- Requirement that at least one unit of the device under
review be retained for CDRH to access upon request
- Greater authorities to require postmarket surveillance
studies as a condition of clearance
- Consolidation of "indication for use" and "intended use" to
"intended use"
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