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TOPIC: Some simple help on device law

Some simple help on device law 08 Jan 2015 04:45 #3113

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About 10 years ago- after the sale of SurgiWrap to MAST Biosciences- I visited the MAST site and saw their write-up on explaining device law i.e. more in particular, what the difference is between a PMA and 510K approval. I was just cleaning up links and before deleting this one- share this, since its useful for folks who are clueless on device law.

Here the very basics are nicely explained- of course there is a helluva lot more on FDA pages and the various parts of the FDA- but thats another chapter... :bye:

is SurgiWrap® FDA approved?
SurgiWrap® and its supportive data has been reviewed and cleared for sale in the U.S. by the FDA. This clearance for sale means that the FDA has found SurgiWrap® to be safe and effective in all soft tissues of the pelvic, and abdominal cavities by determining SurgiWrap® to be substantially equivalent to existing "like" products previously cleared by FDA.
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What is the difference between a PMA approval and a 510(K) clearance?
A total new device or material for a new application requires a pre market approval (PMA) because reasonable assurance of safety and effectiveness has not been proven. A 510(K) clearance is issued to devices or materials that are similar to devices or materials that have been on the market prior to 1975 or previously cleared as a 510(K) by FDA.
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Is an approval necessary for hospitals to purchase a product or a surgeon to use a product?
No. Many commonly used surgical instruments such as staples, sutures, and trocars follow the same 510K regulatory pathway as SurgiWrap and therefore are cleared for use, and using FDA wording, are not approved. Products need to be reviewed by the FDA for classification, evaluation, and authorization. Upon review, the FDA will determine if the new product requires further clinical evaluation in the form of a PMA study, or standards testing for a 510(K), both FDA mechanisms are used to access safety and efficacy.
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Why didn't SurgiWrap® require a PMA?
SurgiWrap® was cleared for sale by the FDA because it is comprised of polylactic acid, a material that has been used safely and effectively in the human body for over 30 years in multiple products. Upon review of the preclinical data and bench top testing by the FDA, no additional testing was required to give reasonable assurance of the products safety and efficacy; therefore clearance for sale was granted.

Link to page: Mast BIO

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