FDA Launches New Program for Combination Product Inspections
This new program was released as part of an update to the Compliance Program Guidance Manual (CPGM), which provides instructions to FDA investigators for conducting compliance evaluation activities. This new program focuses primarily on clarifying the application of cGMP requirements to single-entity and co-packaged finished combination products (i.e. a prefilled syringe or a syringe packaged with a container of drug product).
Manufacturers demonstrate cGMP compliance one of two ways: either through full compliance with all cGMP regulations, or through a more streamlined approach which creates flexibility for manufacturers. This streamlined approach requires compliance with:
Definition of a Combination Product: A combination product is a product comprised of two or more different types of medical products (i.e., drug and device, drug and biological product, device and biological product, or all three together) (see 21 CFR 3.2(e)). A constituent part of a combination product is a drug, device, or biological product that is part of a combination product.
Examples of combination products include:
FDA releases quarterly report (Q2 FY 2020) on device submissions and device-related guidance documents.
Lunit wins CE Mark (approval in Europe) for AI-based breast cancer detection software.
Insight MMG uses AI to analyze mammography images and provide the location of lesions that are suspicious for breast cancer, along with an abnormality score that reflects the probability of the existence of detected lesions. According to a news release, the software analyzes the images with 97% accuracy.
Recently in February, a study using Lunit INSIGHT MMG has been published in Lancet Digital Health, showing the added value of AI-aided breast cancer detection from mammography images. The study showed a significant improvement in the performance of radiologists, before and after using AI. According to the study, the AI alone showed 88.8% sensitivity in breast cancer detection, whereas radiologists alone showed 75.3%. When radiologists were aided by AI, the accuracy increased by 9.5% to 84.8%.
Lunit is a medical AI software company devoted to conquering cancer and advancing medical intelligence to the next level. The company is based in South Korea.Quality / Compliance / Regulatory Updates – 12 June 2020
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