(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance
The FDA Law Blog
SEPTEMBER 26, 2022
much like an FDA guidance document. Some low-risk devices are exempt from cGMPs except for complaint handling and record keeping requirements, e.g. , a liquid medication dispenser ( 21 C.F.R. FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. The recent FR Notice does not modify § 4.4,
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