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Senator tells FDA to Seek Medical Device
Industry's Expertise Before Changing 510(k) Process
U.S. Senator Al Franken (D-MN) urged a top official at FDA to
seek input from medical device manufacturers in Minnesota and across the country
before changing the approval process for new products.
In a letter to Dr. Jeffrey Shuren, Director of the Center for
Devices and Radiological Health at FDA, Franken said the expertise and concerns
of manufacturers too often have been ignored when changes are made to the 510(k)
review process for new products.
"I understand that FDA has asked the Institute of Medicine
(IOM) to review the current 510(k) process and specifically to consider several
issues relating to the device review and approval process," Franken wrote to
Shuren in a letter. "I believe that the medical device industry contains a
wealth of expertise that is too often neglected when considering changes to the
device review process. I strongly encourage you to establish a clear process for
soliciting and considering the suggestions and concerns of the medical device
industry on any and all recommendations made by IOM before finalizing or
implementing any changes to the process."
The Institute of Medicine is expected to issue its
recommendations to FDA on changes to the 510(k) regulatory process.
Franken has heard from Minnesota companies that the process is too onerous and
hinders efforts to bring new life-saving devices to the market. Last year, he
met with FDA Commissioner Margaret Hamburg, who committed to releasing specific
plans for changes to the process by the end of the 2010 and to seeking public
comment before implementing those changes. Prior to the meeting with Hamburg,
Franken held a summit in Minnesota with leading Minnesota medical device
manufacturers to hear their concerns regarding FDA's regulatory process.
Minnesota's medical device community includes more than 400 companies that
employ more than 30,000 people. Franken sits on the Senate Health, Education,
Labor, and Pensions Committee, which oversees FDA.
http://www.mddionline.com/blog/executivesuite/senator-tells-fda-seek-medical-device-industrys-expertise-changing-510k-process.
Implant Mimics Cancellous and Cortical
Bone
Korean researchers have developed a technique for producing
cancellous and cortical bone implants. Previous studies have focussed on
producing cancellous bone, which has a spongy, honeycombed structure. However,
artificial bones for practical applications must also imitate cortical bone, the
hard, strong tissue found on the outer layers of bone. By mimicking natural
bone, it is hoped the implant material will better complement the natural
regeneration process. The research by Yang-Hee Kim and Byong-Taek Lee from the
Department of Biomedical Engineering and Materials, School of Medicine, at
Soonchunhyang University is published in the current issue of Science and
Technology of Advanced Material (STAM).
Cortical bone is less porous than cancellous bone, but
contains canals through which the nutrients for bone formation flow. By
developing a process to imitate this canal structure, the researchers have made
significant advances in the fabrication of artificial bones, notes the National
Institute for Materials Science (NIMS) in a press release.
The technology involves wrapping hydroxyapatite-loaded
PMMA-PCL around 0.3-mm-diam steel wires by means of electrospinning. The
biopolymer bundles cover a scaffold of cancellous bone structure, made by the
standard sponge replica method out of zirconia (ZrO2) and biphasic calcium
phosphate (BCP). Removal of the steel wires reveals an interconnected structure
that mimics small human bones.
The resulting structure is characterised by high strength and
approximately 70% porosity, similar to natural bone. Although tests have shown
the material to be biocompatible, further in vitro and in vivo research is
needed to fully evaluate its biological properties.
An ageing population makes bone loss and fracture a major
worldwide problem and stimulates bone regeneration research. Biomimetic
approaches to making artificial implants have attracted much attention, but the
dependence of the healing process on interaction with the implant material
requires close mimicry of the architecture of natural bone. This paper marks a
significant advance in the development of materials and processing technology
for the fabrication of artificial bone structures, according to NIMS.
http://medtechinsider.com/archives/23467
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