Outline • Combination Products • Jurisdiction • Regulatory Challenges • Regulations/Guidance for Industry • Human Factor Studies • Comparability • Case Studies . 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. Reviews key issues such as Primary Mode of Action, Requests for Designation, and how to handle GMPs and Adverse Event Reporting for combination products. By integrating our engineering, quality, and regulatory expertise—we can help you understand the challenges you face—and develop a plan to meet them. InFuse™ Product . (p) … Manufacturers impacted by PMSR reporting rules. Examples . 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. 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 guidance outlines what is expected of both sides in such meetings. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). FDA has pushed out these compliance deadlines by one year from its previous timeframe set in 2018. No Summary Malfunction Reporting: Eligible: Recognized Consensus Standards. 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? 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. DTP/OPB/OPS/CDER/FDA . WCBP 2012 . COMBINATION PRODUCTS – Perspectives on FDA Regulation Michael A. Swit, Esq. The FDA hit Menlo Park, California-based Intersect ENT with a Form 483 over serious violations at its facility, including problems with environmental monitoring. MedTech Intelligence photo. The FDA has unveiled a new compliance program for inspections of combination products. No 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. Subpart A - Current Good Manufacturing Practice Requirements for Combination Products § 4.1 - What is the scope of this subpart? The combination of similar components, such as a drug-drug or a device-device, is not classified as a combination product per FDA regulations. 2. § 4.4 - How can I comply with these current good manufacturing practice requirements for a … Combination products regulation at the FDA Clin Pharmacol Ther. The FDA further sub-classifies combination products: 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. FDA outlines its fundamental expectations for applying human factors engineering (HFE) to combination products in its published guidance documents. These documents clearly communicate that applying HFE during development is essential to ensure that combination products are safe and effective. (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. Associate Chief, Laboratory of Biochemistry . 2009 May;85(5):468-70. doi: 10.1038/clpt.2009.28. 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? § 4.3 - What current good manufacturing practice requirements apply to my combination product? § 4.2 - How does FDA define key terms and phrases in this subpart? ( 4 ) groups: 1 quality, and the combined regulations apply to combination... 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