FDA to Get Tough on All-Metal Hip Implants

Published date : 28 January 2013
Article date : 28 January 2013


Arthritis Today (US) reports that the FDA is proposing to introduce new rules that would require manufacturers of metal-on-metal hip-replacement implants to either prove their products are safe or stop selling them. A high level od early failure rates and the shedding of microscopic metal particles in the body have led to calls for stricter regulation of the devices.

Under the proposals, manufacturers would have 90 days to submit data showing that an implant is safe and effective. Metal implants that don’t meet these requirements would be removed from the market.
There will be a 90 day comment period where manufacturers, the public and others can submit their views about the new rules which will be reviewed by the FDA. The whole process is anticipated to take around a year.
Source: Linda Rath, Arthritis Today, 28 January 2013.

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