RAC Prep Medical Devices 2024 | 70
Questions with 100% Correct Answers |
Verified | Latest Update 2024| Graded
A+
Preamendment device - ✔✔Devices legally marketed by a US firm before May
28, 1976 that have not changed or been modified significantly since approval and
for which FDA has not issued a regulation requiring PMA.
-Must have same intended use and same owner
-New intended use = 510(k) required
FDA Form 3752 - ✔✔Pre-amendment device determination request
-Must demonstrate the device was labeled, promoted and distributed for a
specific use and that use has not changed.
,513(g) Request for Information - ✔✔Requires a letter with device description
and fee payment
FDA will provide the following within 60 days:
-the generic type of device (e.g., classification regulation) that the requester's
device appears to be within (if any);
·-the class of devices within that generic type (and if there is more than one
class within that generic type, the particular class within which the requestor's
device appears to fall);
·-whether a PMA, 510(k), or neither is required in order to market devices of
the particular class within that generic type;
·-other requirements applicable to devices of the particular class within that
generic type;
·-whether a guidance document has been issued regarding the exercise of
enforcement discretion over the particular class of devices within that
generic type;
,·-whether additional FDA requirements may apply, such as those applicable
to radiation-emitting products.
-Not final agency action, but responsive info
General device controls - ✔✔Apply to ALL medical devices unless exempted
in classification
-Establishment registration
-Medical device listing
-21CFR 820 compliance (QSR)
-Labeling devices per 21CFR 801 or 809
-Notification (recalls)
-Records and reports
-Submitting 510k before marketing
Special device controls - ✔✔-Special labeling requirements
-mandatory performance standards
, -patient registries for implantable devices
-Post marketing surveillance activities
Premarket Approval (PMA) - ✔✔-Must receive FDA approval before marketing
-Contains scientific evidence of safe and effective
-Typically takes 180 days for FDA to review
Review steps as follows:
-acceptance review (15 days)
-review manufacturing section for QSR compliance
-filing review and decision (45 days)
-Day 100 meeting
-PAI
-BIMO audit of clinical data
-Substantive review (90 days)
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