2007 Compliance FDA Governance 
Drug & Device Law
AUGUST 8, 2022
So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards. Furthermore, trade associations often serve to assist the government in areas that it does not regulate. has no power to enforce compliance”), aff’d , 405 F. at 183 (quoting Meyers v.
Drug & Device Law
JANUARY 25, 2024
142 (2007), mere regulation of the product or conduct at issue—the medical walker is a non-prescription, Class I medical device with general controls only—is not a basis for removal under this statute. In those cases , the question is often whether the claims put FDA compliance at issue or whether the defenses do.
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