I was referring to two completely different things:
When I said that "No FDA approval is required" I was talking about the silkworms as the product and no approval being required for the use of the silkworms, not for products from the worms (just as I also said in the same paragraph that the worms also did not need regulatory approval for GMOs because they were not to be released into the environment and could not survive in the wild even if accidentally released.
In another post talking about medical uses of silk I noted that devices incorporating silk would need regulatory approval. Silk has been used for sutures for thousands of years (I think I incorrectly said hundreds in that post) so its internal use is well established. But the rest of the device would need approval. Even a device previously approved that just wanted to substitute silk for one of its materials would need approval. The FDA would want it proven that silk would work in that context.
Basically every new medical device must get FDA approval. (When in doubt, require clinical trials, is the basic attitude.) The use of stents is well established. But when a drug company wanted to make a stent with a drug incorporated into the stent, that required FDA approval even though both the stent and the drug had already been approved as separate products.
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