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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?
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?