Ten More Class I Devices Would Require 510(k)s Under FDA Proposed Rule
This article was originally published in The Gray Sheet
Ten additional Class I devices would be placed on FDA's "reserved" list of devices requiring a 510(k) submission under a proposed rule published in the Nov. 12 Federal Register.
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Effective Feb. 14, rule lists all Class I and Class II devices that are exempted from premarket notification under the 1997 FDA Modernization Act. List includes cardiopulmonary bypass accessory equipment and electrode cables, devices which initially had been removed from the list following an FDA proposed rule reclassifying them to Class II and requiring them to meet certain performance standards (1"The Gray Sheet" Nov. 16, 1998, p. 10). The agency explains that as long as these devices met the standard there was no need for them to submit a 510(k), and clarified that this decision would have no effect on the proposed reclassification. On its own initiative, the agency also has added all versions of keratoscopes to the list; previously, keratoscopes using computer software were not considered exempt
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