FDA proposes new fast path to market for certain medical devices
Dec 11 (Reuters) - The U.S. Food and Drug Administration on Monday proposed creating a new fast track to market for certain medical devices and a potential reduction in the amount of safety data required for approval.
Commissioner Scott Gottlieb announced the proposal in a blog posted on the FDA's website. If implemented, it could save device companies millions of dollars in product testing and shave years off development times.
Gottlieb's proposal would offer an alternative route to market for certain companies which do not meet the criteria for clearance under the agency's existing fast track route, known as the 510(k) pathway.
To win 510(k) clearance a product must be moderate risk and substantially equivalent to an existing device, called a predicate. High-risk products such as implantable heart devices must go through a more rigorous process.
Gottlieb said that advancing technology means it can be hard for companies to identify a suitable predicate, "which can create an obstacle to certain kinds of innovation and lead to inefficiency in the review process."
His new proposal would dispense with the need for a predicate and offer the option of using a benchmark consisting of a set of performance standards or guidance documents. The plan would be voluntary.
Read More: http://bit.ly/FDANewPath
Commissioner Scott Gottlieb announced the proposal in a blog posted on the FDA's website. If implemented, it could save device companies millions of dollars in product testing and shave years off development times.
Gottlieb's proposal would offer an alternative route to market for certain companies which do not meet the criteria for clearance under the agency's existing fast track route, known as the 510(k) pathway.
To win 510(k) clearance a product must be moderate risk and substantially equivalent to an existing device, called a predicate. High-risk products such as implantable heart devices must go through a more rigorous process.
Gottlieb said that advancing technology means it can be hard for companies to identify a suitable predicate, "which can create an obstacle to certain kinds of innovation and lead to inefficiency in the review process."
His new proposal would dispense with the need for a predicate and offer the option of using a benchmark consisting of a set of performance standards or guidance documents. The plan would be voluntary.
Read More: http://bit.ly/FDANewPath
