§ 4.2 - How does FDA define key terms and phrases in this subpart? Overview of FDA regulation of combination products -- those featuring a drug and a device, a device and a biologic, or a biologic and a drug. The combination of similar components, such as a drug-drug or a device-device, is not classified as a combination product per FDA regulations. FDA on the combination product. The FDA further sub-classifies combination products: Affiliation 1 Office of Combination Products, US Food and Drug Administration, Rockville, Maryland, USA. MedTech Intelligence photo. These documents clearly communicate that applying HFE during development is essential to ensure that combination products are safe and effective. The FDA has unveiled a new compliance program for inspections of combination products. CPAM should not be used to resolve disputes that would otherwise be addressed under the lead center’s dispute resolution or appeals process (see below) . 3 . Subpart A - Current Good Manufacturing Practice Requirements for Combination Products § 4.1 - What is the scope of this subpart? Examples . 4-233 ISO … The CPC has provided this document to inform potential guidance on cross-labeled combination products and “combined use,” noting that this has not been agreed to by FDA, but we hope can facilitate future discussions on the topic. No As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. To read the rest of the article, please click the link to Pharmaceutical Online … In the text, FDA defines combination products as “any combination of a drug, a device, and/or a biological product” before outlining how it reviews and regulates the category. HPM has assisted numerous companies with the development of combination products and strategies for approval and routes to market. WCBP 2012 . § 4.4 - How can I comply with these current good manufacturing practice requirements for a … First US FDA Submission of Wearable Drug-Device Combination Product Based on Sensile Medical's SensePatch Drug Delivery Technology November 06, 2017 04:06 AM Eastern Standard Time Outline • Combination Products • Jurisdiction • Regulatory Challenges • Regulations/Guidance for Industry • Human Factor Studies • Comparability • Case Studies . Injector Pen Implanted . Combination Products: A Regulatory Perspective Kathy Lee, M.S. Additional details about the classification of combination products can be found in four subparts within 21 CFR 3.2(e). CPAMs may be appropriate for seeking agreement from FDA on an approach if previous feedback under an application-based mechanism has not provided sufficient certainty. (o) Product jurisdiction officer is the person or persons responsible for designating the component of FDA with primary jurisdiction for the premarket review and regulation of a combination product or any product requiring a jurisdictional designation under this part. 2. COMBINATION PRODUCTS – Perspectives on FDA Regulation 1. InFuse™ Product . Product Code: LHQ: Premarket Review: Division of Radiological Health (DRH) Division of Radiological Health (DRH) Submission Type: 510(k) Regulation Number: 884.2980: Device Class: 1 Total Product Life Cycle (TPLC) TPLC Product Code Report: GMP Exempt? (p) … Manufacturers impacted by PMSR reporting rules. Combination Products Defined. These interactions can occur through application-based mechanisms, such as the pre … On December 4, 2020, FDA finalized the guidance document, Requesting FDA Feedback on Combination Products (Guidance), which was issued to fulfill the requirement under Section 3038 of the Cures Act. FDA has pushed out these compliance deadlines by one year from its previous timeframe set in 2018. The compliance program for combination products issued by the FDA is intended to describe the regulatory framework related to inspections of manufacturing sites producing single-entity and co-packaged combination products. The FDA has broken down combination products into four (4) groups: 1. No Summary Malfunction Reporting: Eligible: Recognized Consensus Standards. Reviews key issues such as Primary Mode of Action, Requests for Designation, and how to handle GMPs and Adverse Event Reporting for combination products. January 2015: Draft guidance, cGMP Requirements for Combination Products, released A product comprised of two or more regulated components, that is, 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. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). A new FDA draft guidance says manufacturers of combination products should first review existing combination product guidances and submit questions before asking for a combination product agreement meeting with regulators to get clarification. Combination product agreement meetings — known within the FDA as CPAMs — are a prime way sponsors of such products can gather agency feedback on their applications, the agency said in a final guidance released yesterday. No Summary Malfunction Reporting: Eligible: Implanted Device? The core of the document is focused on best practices for interactions between sponsors and FDA and the mechanisms through which the agency provides feedback on combination products. In 1990, the US Congress amended the Federal Food, Drug and Cosmetic Act to introduce the concept of combination products and to clarify product jurisdiction issues. By integrating our engineering, quality, and regulatory expertise—we can help you understand the challenges you face—and develop a plan to meet them. 2 . The requirements set forth in the present document are also based on the CGMPs applicable to drugs, medical devices, and biological products, while the … Combination product agreement meetings — known within the FDA as CPAMs — are an essential tool sponsors can use to gather agency input on their applications, the agency said in a final guidance released late last week. Personnel looking for a general understanding of the FDA Combination Product Process; Dr. David Lim. The agency’s Feb. 27-March 6 inspection of the combination drug-device manufacturing facility turned up four observations, including the firm’s failure to follow its standard operating procedures. § 4.3 - What current good manufacturing practice requirements apply to my combination product? FDA outlines its fundamental expectations for applying human factors engineering (HFE) to combination products in its published guidance documents. COMBINATION PRODUCTS – Perspectives on FDA Regulation Michael A. Swit, Esq. Associate Chief, Laboratory of Biochemistry . Our combination product assessment will give you an expert vantage point to see solutions to development or quality challenges. The guidance outlines what is expected of both sides in such meetings. Developers of combination products have new final guidance from the US Food and Drug Administration about requesting feedback from the agency during the full product development cycle. WHAT FDA IS SEEING. FDA’s 2015 Guidance Documents & Rules A panel of experts at a combination product conference last month discuss the developments and challenges faced in product development and communication with the various centers at FDA. Dr. David Lim, Ph.D., RAC, ASQ-CQA. DTP/OPB/OPS/CDER/FDA . The DIA/FDA’s Complex Generic Drug-Device Combination Products Conference will examine current knowledge and ongoing scientific research of the FDA Office of Generic Drugs (OGD) supporting evidence-based development, assessment, and approval of complex generic combination products. FDA is announcing the availability of a guidance for industry entitled “Requesting FDA Feedback on Combination Products.” The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from the Agency on scientific and regulatory questions. Join FDA staff and industry experts to discuss these topics, as well as common review … Product Code: MQC: Premarket Review: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1) Dental Devices (DHT1B) Unclassified Reason Pre-Amendment Submission Type: 510(k) Device Class: Unclassified Total Product Life Cycle (TPLC) TPLC Product Code Report: GMP Exempt? We help our clients determine the jurisdictional boundary between the centers at FDA (i.e., CDER, CBER, CDRH, or CFSAN). Issues Appropriate for CPAMs. January 31, 2021 for combination product manufacturers using FDA’s Vaccine Adverse Event Reporting System (VAERS) for reporting on ICSRs. The U.S. defines a combination product as a drug and device; a biological product and device; a drug and biological product; or a drug, device and biological product (21 CFR §3.2(e)). The program applies to inspections of manufacturers of single-entity and co-packaged finished combination products that include both drug and device or biological product and device constituent parts. Upon its creation, the Office became broadly responsible for overseeing the regulation of combination products, or products that involve components that would normally be regulated under different FDA Centers. The Office of Combination Products (OCP), within the Food and Drug Administration (FDA), was created formally by statute in December, 2002. Vice President, Life Sciences Biotech Vendor Services Presents Orange County Biomedical Day Irvine, California September 19, 2007 The FDA hit Menlo Park, California-based Intersect ENT with a Form 483 over serious violations at its facility, including problems with environmental monitoring. Combination products regulation at the FDA Clin Pharmacol Ther. Each of these constituent parts is governed by a specific set of FDA regulations, and the combined regulations apply to the combination product. 2009 May;85(5):468-70. doi: 10.1038/clpt.2009.28. The CPC has provided this document to inform potential guidance on cross-labeled combination products and “combined use,” noting that this has not been agreed to by FDA, but we hope can facilitate future discussions on the topic. 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