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Elizabeth Hrycko
I have a customer who just added an "FDA Cleared" logo to their product box. we are the mfg. of said product which is classified as follows:
Description: Exerciser, non-measuring
Product code: ION
Device Class: 1
Regulation No: 890.5370
Submission type 510(K) Exempt
GMP Exempt Yes, except for section 820.180 General requirements concerning records and 820.198 regarding complaints)
My question is whether or not it is ok for them to put this logo on the product since it is exempt and doesn't require fda clearance? I haven't had a lot of experience with FDA regulations other than part 820 of CFR 21 and couldn't find a clear answer on anything I read on the FDA website. Any help is greatly appreciated!
Description: Exerciser, non-measuring
Product code: ION
Device Class: 1
Regulation No: 890.5370
Submission type 510(K) Exempt
GMP Exempt Yes, except for section 820.180 General requirements concerning records and 820.198 regarding complaints)
My question is whether or not it is ok for them to put this logo on the product since it is exempt and doesn't require fda clearance? I haven't had a lot of experience with FDA regulations other than part 820 of CFR 21 and couldn't find a clear answer on anything I read on the FDA website. Any help is greatly appreciated!