RAC Device General Exam Prep Graded A+

A 510k is Approved or Cleared? - ANSWER-Cleared A type of 510(k) submission for device modifications neither affecting the intended use nor altering its fundamental scientific technology. FDA processing time is 30 days. - ANSWER-Special 510(k) A type of 510(k) submission that is supported by conformance with guidance document(s), special controls or standards. FDA processing time is 90 days. In other words, it's a "paper comparison," showing substantial equivalence to a guidance or standard. - ANSWER-Abbreviated 510(k) A premarket notification submitted to FDA to demonstrate that the medical device to be marketed is as safe and effective or "substantially equivalent" to a legally marketed device. 510(k) refers to the section of the FD&C Act authorizing the submission of the premarket notification. - ANSWER-Traditional 510(k) Type of submission for a change to a manufacturer's own Class 2 device, previously cleared with 510k. - ANSWER-Special 510k Number of days for FDA to review 510k for acceptance of submission - ANSWER-15 Class of medical devices that are allowed to have a third party review of 510k (instead of FDA) - ANSWER-Two (II) A change is made to a 510 cleared device with the intent to significantly improve the device. Is a new 510k required? - ANSWER-Yes. Per FDA: Changes made with intent to significantly affect safety or effectiveness of a device - If a manufacturer modifies their device with the intent to significantly affect the safety or effectiveness of the device (for example, to significantly improve clinical outcomes, to mitigate a known risk, in response to adverse events, etc.), submission of a new 510(k) is likely required. A change intended to significantly affect the safety or effectiveness of the device is considered to be a change that "could significantly affect the safety or effectiveness of the device" and thus requires submission of a new 510(k) regardless of the considerations outlined below. What types of FDA submissions required clinical evaluation? - ANSWER-PMAs, HDEs and de novo classifications (and some 510ks) FDA review period for IDEs? - ANSWER-30 days (approval, approval with conditions or disapproval) Types of Clinical Trials (Medical Devices) - ANSWER-(1) Pilot/EFS/FIH, (2) Traditional Feasibility, (3) Pivotal, (4) Post Market