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(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance

The FDA Law Blog

FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. The list of alternative mechanisms for complying with Part 211 in this FR Notice is not different from what was proposed in the 2018 FR Notice. or that FDA proposes can satisfy the requirements in § 4.4 much like an FDA guidance document.

FDA 40
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New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

The FDA Law Blog

Background The Breakthrough Devices Program, established under section 515B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), is a voluntary program for certain medical devices and device-led combination products.