Determining
whether you need FDA
510k or PMA for your medical device will depend on the classification of
your device. Every device manufacturer who wishes to trade in the US market
needs to classify their medical device as Class I, II, and III. Premarket
approval application (PMA) is not necessary if those are meant to human use,
but must submit FDA 510 (k) unless the device is exempt from 510 (k) necessity
of the Federal Food, Drugs and Cosmetic Act (the FD&C Act), and does not
overreach the circumstance of exemptions of the device classification
regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9).
The domestic
medical device manufacturers from any country trying to introduce a new device
to the US market. Re-packers or Re-labellers who make labelling changes or
whose operations significantly affect the device.
Operon Strategist
is a medical device regulatory consulting company which provides regulatory
advisory & guidance to various manufacturers in the healthcare industry to
ensure the strategic development of these manufacturers
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