The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 2. IMDRF has essentially consolidated forces with a focus on accelerating international medical device regulatory harmonization. Above all, if you need help with a pre-submission request, RFD (request for designation), or combination products generally, contact PDG! This injection history can be emailed directly to the patient or physician, so it is an added feature that benefits the patient and allows oversight by the healthcare provider. The broad assumption in the industry is that if a combination or sensitive product … Not for implementation. Section 3038 of the 21st Century Cures Act, enacted in December 2016 (P.L. [1] Combination products should not be confused with Fixed-Combination Drugs (FCDs), which are drug-drug combinations. Labeling products as sterile. As recently as September 21, 2016, FDA released a draft guidance for the Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices. To reach its ultimate goal of multinational approval, the company needed to develop a regulatory strategy by which the classification of its product as a combination device could be preserved, country-specific clinical trials could be avoided, and the approval process could be expedited. It is also broken down by specific products. ©2019. Present Regulatory Pathway for Biologics in US: According to Bayer “all a patient will have to do is prepare the Betaseron® syringes provided in the medication pack and use BETACONNECT® for a more convenient and effective delivery”, that allows patient to select the speed and depth of injections as well. The regulatory pathways for drug-device combination products can be confusing – generally, companies decide to pursue a drug pathway or a device pathway based on the primary mode of action. The US Food and Drug Administration’s (FDA) Office of Combination Products (OCP), established by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), is the regulatory body responsible for covering the regulatory life cycle of combination products, including serving as a focal point for combination product issues, developing guidances, … The 505 (b) (2) development pathway provides far more efficient drug development for follow-on products by allowing reliance on certain external data and information for the NDA. Combination products are assigned to Centers with primary jurisdiction for premarket reviews and regulation. We have experts on staff with experience in drug, device and combination product registrations to assist you with all of your consultancy needs. It is estimated that “approximately 1/3 of all medical products under development today are combination products and total sales could reach $115 billion dollars by 2019”. Key Point Summary: 1. There is not always a clear-cut pathway. IMDRF is a voluntary group of medical device regulators from around the globe, including FDA, who have come together to build on the strong foundational work of the GHTF. General themes of these amendments include enhancing clarity, predictability, efficiency, and consistency of premarket regulatory expectations for combination products, including by ensuring that Agency components and staff coordinate appropriately on premarket review of these products, and that Agency thinking is aligned in conducting these reviews. In fact, the agency recently released a draft guidance entitled, “Software as a Medical Device (SaMD): Clinical Evaluation.” The draft guidance focuses on establishing the scientific validity, clinical performance, and analytical validity for these types of applications. For combination products, “Intended mode of action by which part” is checked. Once you know what regulation applies to your product … Prior experience in working with the 505(b)(2) regulatory pathway facilitates the use of appropriate data from the literature, product labels, and OTC monographs to reduce the clinical requirements for approval of the final combination product. She held her most recent position for 9 years, as QA/RA Director for a worldwide distributor of medical devices. [4] Search for FDA Guidance Documents, Draft Guidance for Industry and FDA Staff, Recalls, Market Withdrawals and Safety Alerts, Search General and Cross-Cutting Topics Guidance Documents, Principles of Premarket Pathways for Combination Products. It is important to have experts on both the drug and device side, not only for the purpose of initial regulatory strategy, but to ensure that through the entire product life cycle, (from design to manufacturing to market), the combination product meets or exceeds quality and regulatory requirements. If unable to submit comments online, please mail written comments to: Dockets Management Jodi Hutchins is an Independent Regulatory and Quality Consultant with over 15 years of global medical device registration experience, to include FDA 510(k) submissions. To be considered a combination product by FDA, there must be two or more regulated components, (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity, or two separate products that are packaged together and per proposed labeling are intended for use together to achieve a desired effect. In order to qualify for participation in the Breakthrough Devices Program, a device must meet two key criteria: 1. [11], Because HF testing is still relatively new, inquiries to the FDA include:[12]. Regulatory Pathways of Drug-Device and Device-Drug Combination Products in the EU – Journal 31 NSF: Ann Arbor, MI. Dykeman said that there is a general belief in the field that device pathway is quicker and cheaper, but that isn’t always the case. The device represents breakthrough technologies that have no cleared or approved alternatives already available on the US market; offer significant advantages over existing alternative devices; and for which availability is in patients’ best interes… There has been an explosion of new and innovative medical device products launched in the US and global markets over the last 5 years. [4] While OCP is not a review/approval Center for your combination product, they do provide general guidance on which pathway is best for your product and to ensure combination products have general oversight. General themes of these amendments include enhancing clarity, predictability, efficiency, and consistency of premarket regulatory expectations for combination products, including by ensuring that Agency components and staff coordinate appropriately on premarket review of these products, and that Agency thinking is aligned in conducting these reviews. [9], Whether your combination product is deemed a drug or medical device for regulatory purposes, testing for both may still be required. Understanding how to bridge your drug to an approved drug and what types of information are appropriate to use is critical to getting your drug approved. Let CP Pathways guide you in building a combination product regulatory culture that unites the best of biopharma and device strategies and people.

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