A corrective helmet is an analog to a protective cap consisting of wearable technology in which a primary element surrounds an upper cranium and the second element is secured as it shades the injured part of the head and in this way, it sustains intra-cranial pressure & helps aides in pediatric head trauma. It is non-invasive though it is classified as a class II medical device and also confirm as Medical device as per FDA definition of Medical device: An instrument, apparatus, implement, machine, contrivance, implant, in-vitro diagnostic reagent, or similar or related article, including a component part, or accessory which is,
(i) Recognized in the official national formulary, or the U.S. Pharmacopoeia, or any supplement to them.
(ii) Intended for use in the diagnosis of disease or …show more content…
The Office of Device Evaluation (ODE) (comes under CDRH), is in charge of program area through which medical devices are cleared for both clinical trials and marketing. To put in plainly, it is responsible for the review and endorsement of most of the devices. The Division of Neurological and Physical Medicine Devices (DNPMD) & Neurodiagnostic and Neurosurgical Devices Branch (NDNB) also reviews the device along with the ODE (Office of Device Evaluation).
My hypothetical device, which falls under class II device, I will take 510(k) premarket notification as a regulatory pathway. To support 510(k), I have to exhibit that the device is substantially equivalent to predicate devices.[2] What’s more, it must (i) have a similar sign for utilizing, (ii) technological characteristics comparable to existing one and (iii) ought not to bring up any new issues of safety & effectiveness.Here, predicate devices are pre-amendment devices, which were cleared, possess moderate risk and were widely & safely used before enactment of Medical Device Amendments Act,
(i) Recognized in the official national formulary, or the U.S. Pharmacopoeia, or any supplement to them.
(ii) Intended for use in the diagnosis of disease or …show more content…
The Office of Device Evaluation (ODE) (comes under CDRH), is in charge of program area through which medical devices are cleared for both clinical trials and marketing. To put in plainly, it is responsible for the review and endorsement of most of the devices. The Division of Neurological and Physical Medicine Devices (DNPMD) & Neurodiagnostic and Neurosurgical Devices Branch (NDNB) also reviews the device along with the ODE (Office of Device Evaluation).
My hypothetical device, which falls under class II device, I will take 510(k) premarket notification as a regulatory pathway. To support 510(k), I have to exhibit that the device is substantially equivalent to predicate devices.[2] What’s more, it must (i) have a similar sign for utilizing, (ii) technological characteristics comparable to existing one and (iii) ought not to bring up any new issues of safety & effectiveness.Here, predicate devices are pre-amendment devices, which were cleared, possess moderate risk and were widely & safely used before enactment of Medical Device Amendments Act,