FDA recognition standard - Extent of Recognition

R

regfocus

#1
For the FDA recognition standard, does anyone can help to explain what does the following statement mean please?


Extent of Recognition:
Complete standard. Data from the test methods in the standard is needed. Additional testing may be necessary for some products.
Does "Complete standard." here mean this specific standard needs to be completely complied with. Or it just says that FDA recognizes the whole standard, but for specific device may or may not complete all the clauses. The clauses need to be complied with depend on the devices. Right?
 
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M

MIREGMGR

#3
Extent of Recognition: Complete standard. Data from the test methods in the standard is needed. Additional testing may be necessary for some products.
In most instances, the FDA adopts published standards in their entirety that are relevant to FDA regulated matters.

In a few instances, though, the FDA has conditionally adopted a Recognized Consensus Standard (RCS), and requires that it be used in conjunction with additional rules/guidelines/standards, or excludes elements of its content for legal or technical reasons.

As examples, RCS 14-76 is required to be used in conjunction with AAMI TIR19, which pertains to the same subject and provides additional technical direction as to governance of particular matters of concern to the FDA. RCS 14-88 excludes the incorporation into the original standard of references to ISO 13485, which of course is not recognized by the FDA since it fundamentally conflicts with their own top level Quality System Regulation, 21 CFR 820.

If the statement after "Extent of Standard" is "Complete Standard" or "Complete Standard and Any Annexes", no conditions or exclusions apply. In the above instance, as the statement says, the FDA may require more testing data than the original standard requires.
 
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