A 510k is Approved or Cleared? - ANSWER-Cleared
A type of 510(k) submission for device modifications neither affecting the intended use nor altering
... [Show More] 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 [Show Less]