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Strategies for Bench Testing
Medical DevicesFor successful testing, choose the right tests and conduct them at the right time—in an appropriate facility.
Medical devices can be tested at various stages in their life cycle. During their initial design, it is important for the design team to check at least some aspects of performance or safety to be sure that they're on the right track. More-extensive prototype testing usually follows completion of the initial design phase, to demonstrate that the device meets its design specifications. Clinical trials may follow.
Testing for regulatory approval, to meet the stated or implicit requirements of one or more regulatory agencies, is performed next; this should be done on production units or on preproduction prototypes that reflect the manufactured product. Once a device has earned approval, production line start-up often requires additional testing to validate the production equipment (for instance, samples from each cavity of a mold) and inspection protocols.
Reprinted from Medical Device & Diagnostic Industry, April 2003 • Copyright © 2003 Canon Communications LLC
Third-Party 510(k) Review:
A More Attractive Alternative?Now that user fees have increased, device makers are advised to give third-party reviewers a second look.
Many device companies have opted for third-party 510(k) reviews to help get their products on the U.S. market months faster. Now, with FDA increasing its review fee from $2187 to $3480 ($2784 for small businesses), effective October 1, 2003, third-party review becomes an even more attractive alternative. The reason? Third-party submissions are completely exempt from the fee.
The third-party review program began in 1996, with just 15 device types eligible; predictably, few companies took advantage of it. Today, most 510(k)s can be reviewed by third parties, with 14 accredited organizations situated around the world. The program allows sponsors to submit their eligible 510(k) applications to an approved third party (an "accredited person," in FDA parlance) rather than directly to FDA. The third-party organization conducts the primary review, which is where months' worth of time can be lost at FDA. When the third party is satisfied that the 510(k) has demonstrated substantial equivalence (i.e., the criterion for clearance), it sends the complete 510(k), together with its review documentation, to FDA for a final decision - which comes quickly.
More ...Reprinted from Medical Device & Diagnostic Industry, October 2003 • Copyright © 2003 Canon Communications LLC
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