Here are four things to know about the proposed policy.
1. The FDA’s regulatory process has remained “largely unchanged” since the Medical Device Amendments of 1976, according to Dr. Gottlieb. The amendments established that manufacturers seeking clearance for moderate-risk devices must demonstrate substantial equivalence to similar devices already marketed in the U.S., known as “predicate devices.”
“This process is generally known as the 510(k) pathway,” Dr. Gottlieb explained. “It’s designed to assess the safety and effectiveness of medical devices whose risks are well understood.”
2. The predicate devices that manufacturers are asked to compare their products to, however, may be up to 40 years old. This challenge “can create an obstacle to certain kinds of innovation” by making it difficult for manufacturers to identify appropriate predicate devices to test against when their products are designed using more advanced technologies, Dr. Gottlieb wrote.
3. To “modernize” the 510(k) pathway, Dr. Gottlieb said the FDA will release draft guidance outlining a framework in which manufacturers demonstrate substantial equivalence to existing devices by meeting a set of safety and performance criteria. The reference criteria will include FDA-recognized standards, FDA-developed guidance and international consensus standards.
4. The alternative pathway will be voluntary and available for pre-specified categories of “mature” and “well-understood” devices, or those for which the FDA is able to identify safety and performance criteria of existing devices, such as ultrasound imaging machines or blood pressure monitors. Manufacturers will have the option to continue seeking clearance under the existing 510(k) pathways.
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