CDRH/CBER, March 2015, Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex - Guidance for Industry and Food and Drug Administration Staff Subsequently, on February 26, 2014, FDA held a webinar regarding the Pre-Sub Guidance (the “Webinar”). January 21, 2021 - U.S. Food & Drug Administration (FDA) released the highly anticipated Safer Technologies Program (STeP) Guidance Document. Since January 2017, it may also include correction or removal actions initiated by a firm prior to review by the FDA. Gleichzeitig liefert dieses Dokument auch Medizin… CDRH/CBER, September 2019, Humanitarian Device Exemption (HDE) Program; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, June 2016, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff This increased communication is especially beneficial for those complex submissions where clinical data is needed or where multiple interactions with the Agency are common. eCopy Program for Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff We follow and understand the changing regulatory landscape due to the COVID-19 Pandemic. Fda risk management guidance medical device empfinden, fehlt Ihnen vermutlich schlicht und ergreifend die Motivation, um den Schwierigkeiten etwas entgegenzusetzen. CDRH/CBER, September 2014, Unique Device Identification System: Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to … This list contains the most recent final medical device guidance documents. 1. CDRH/CBER, February 2003. CDRH/CBER, October 2013, Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and FDA Staff CDRH/CBER, October 2017, Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, August 2018 - (This document supersedes “FY 2018 Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff and Foreign Governments” dated August 29, 2017. CDRH/CBER, July 2020, Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff The major difference between the programs is in the eligibility criteria. CDRH/CBER, April 2013, Humanitarian Use Device (HUD) Designations; Guidance for Industry and FDA Staff Verschieben wir gleichwohl unseren Blick darauf, was sonstige Anwender über das Mittel zu sagen haben. They are intended to assist in preparing the various device licence applications required when seeking an authorization to sell a medical device product in Canada. #27 2021 Outlook on FDA Submissions. CDRH/CBER, December 2019, Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration Staff FDA hosted a webinar to discuss this new medical device guidance on May 11, 2020. CDRH/CBER, August, 2013, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products; Guidance for Industry and FDA Staff CDRH/CBER/CDER, September 2019, Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff Major guideline available on this subject is, "ISO 10993-1:2018 - Biological evaluation of medical devices". CDRH/CBER, December 2019, FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, September 2017, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff 2018-10-21. To submit a request for your medical device or device-led combination product for the SteP designation you must do so in a Q-Submission, with the request being the only item in the Q-Submission. CDRH/CBER, August 2019, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications; Guidance for Industry and Food and Drug Administration Staff Check out our Regulatory services for more information and learn more about RQM+ here. The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws passed by Congress that apply to food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices. Interestingly though, the guidance does not provide examples for what happens if one device addressing the same safety issue gets cleared before another. Guidance, Law & Regulations; Medical Devices; Medical Devices. Regulations for Governing the Management of Medical Device. While being able to demonstrate reduction in a “known” safety risk would improve the benefit-risk determination, it would not change the devices overall risk classification (i.e. The site is secure. 4. The SE evaluation for 510(k)s will also not be impacted by inclusion of the device in STeP, meaning that “substantial safety innovations” may still raise different questions of safety and effectiveness and be kicked off the flowchart. CDRH/CBER/OOPD, January 2013, In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions; Guidance for Industry and FDA Staff FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs); Draft Guidance for Industry, Food and Drug Administration Staff, and … No. FDA has issued additional guidance for potential drug shortages during the COVID-19 public health emergency. 2018-11-22. CDRH/CBER, December 2018, Manufacturing Site Change Supplements: Content and Submission ; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, November 2020, The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff #15 When to use the FDA Q-Submission (Pre-Sub) Program. CDRH/CBER, September 2019, Refuse to Accept Policy for 510(k)s; Guidance for Industry and Food and Drug Administration Staff 2.29 Where do I send my MDR reports? CDRH/CBER, December 2008, Indexing Structured Product Labeling One of the things I can appreciate about FDA is the clarity of its website and some of its guidance documents. Published 6 January 2021. Food & Drug Administration (FDA). a PMA would still be a PMA). CDRH/CBER, September 2019, Policy for Device Software Functions and Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff General Biologics Guidances, Recalls, Market Withdrawals and Safety Alerts, Adverse Events and Product Deviation Guidances, Guidance, Compliance & Regulatory Information (Biologics), Safer Technologies Program for Medical Devices; Guidance for Industry and Food and Drug Administration Staff, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff, Electromagnetic Compatibility (EMC) of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff, Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices; Guidance for Industry and Food and Drug Administration Staff, The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff, Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff, Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"; Guidance for Industry and Food and Drug Administration Staff, Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff, Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act, Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff, Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers Guidance for Industry and Food and Drug Administration Staff, Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Guidance for Industry and Food and Drug Administration Staff, Nonbinding Feedback After Certain FDA Inspections of Device Establishments; Guidance for Industry and Food and Drug Administration Staff, Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff, 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes; Guidance for Industry and FDA Staff, Acceptance and Filing Reviews for Premarket Approval Applications (PMAs); Guidance for Industry and Food and Drug Administration Staff, Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration Staff, FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff, Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices, Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff, FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals; Guidance for Industry and Food and Drug Administration Staff, Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act; Draft Guidance for Industry and Food and Drug Administration Staff, Policy for Device Software Functions and Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff, Clinical Decision Support Software; Draft Guidance for Industry and Food and Drug Administration Staff, Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff, The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff, Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders, Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff, Refuse to Accept Policy for 510(k)s; Guidance for Industry and Food and Drug Administration Staff, The Abbreviated 510(k) Program; Guidance for Industry and Food and Drug Administration Staff, The Special 510(k) Program; Guidance for Industry and Food and Drug Administration Staff, Format for Traditional and Abbreviated 510(k)s; Guidance for Industry and Food and Drug Administration Staff, User Fees and Refunds for De Novo Classification Requests; Guidance for Industry and Food and Drug Administration Staff, Acceptance Review for De Novo Classification Requests; Guidance for Industry and Food and Drug Administration Staff, FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals; Guidance for Industry and Food and Drug Administration Staff, User Fees and Refunds for De Novo Classification Requests ; Guidance for Industry and Food and Drug Administration Staff, Humanitarian Device Exemption (HDE) Program; Guidance for Industry and Food and Drug Administration Staff, Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, Male Breast Cancer: Developing Drugs for Treatment; Draft Guidance for Industry, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications; Guidance for Industry and Food and Drug Administration Staff, Unique Device Identification: Convenience Kits; Guidance for Industry and Food and Drug Administration Staff, Review and Update of Device Establishment Inspection Processes and Standards; Draft Guidance for Industry, The Least Burdensome Provisions: Concept and Principles; Guidance for Industry and FDA Staff, Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration, Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products; Draft Guidance for Industry, User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications ; Guidance for Industry and Food and Drug Administration Staff, Manufacturing Site Change Supplements: Content and Submission ; Guidance for Industry and Food and Drug Administration Staff, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff, Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics; Guidance for Industry and Food and Drug Administration Staff, Recognition and Withdrawal of Voluntary Consensus Standards; Draft Guidance for Industry and Food and Drug Administration Staff, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices; Guidance for Industry and Food and Drug Administration Staff, Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff and Foreign Governments, Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests - Guidance for Industry and Food and Drug Administration Staff, Multiple Function Device Products: Policy and Considerations; Draft Guidance for Industry and Food and Drug Administration, Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics; Guidance for Stakeholders and Food and Drug Administration Staff, Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions; Guidance for Industry and Food and Drug Administration Staff, Acceptance and Filing Reviews for Premarket Approval Applications (PMAs); Guidance for Industry and Food and Drug Administration Staff, Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff, FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions; Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards and Food and Drug Administration Staff, Medical Device Accessories - Describing Accessories and Classification Pathways; Guidance for Industry and Food and Drug Administration Staff, Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff, Clinical and Patient Decision Support Software; Draft Guidance for Industry and Food and Drug Administration Staff, Unique Device Identification: Direct Marking of Devices; Guidance for Industry and Food and Drug Administration Staff, De Novo Classification Process (Evaluation of Automatic Class III Designation); Guidance for Industry and Food and Drug Administration Staff, Deciding When to Submit a 510(k) for a Software Change to an Existing Device; Guidance for Industry and Food and Drug Administration Staff, FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals; Guidance for Industry and Food and Drug Administration Staff, FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals; Guidance for Industry and Food and Drug Administration Staff, User Fees for 513(g) Requests for Information; Guidance for Industry and Food and Drug Administration Staff, Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff, Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions; Guidance for Industry and Food and Drug Administration Staff, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions; Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff, Postmarket Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration Staff, Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices - Guidance for Industry and Food and Drug Administration Staff, Patient Preference Information - Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling - Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders, Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Guidance for Industry and Food and Drug Administration Staff, Adaptive Designs for Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff, Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI); Draft Guidance for Industry and Food and Drug Administration Staff, Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product; Draft Guidance for Industry and Food and Drug Administration Staff, Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices; Guidance for Industry and Food and Drug Administration Staff, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff, FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff, eCopy Program for Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff, Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015; Guidance for Industry and Food and Drug Administration Staff, Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Guidance for Industry and Food and Drug Administration Staff, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex - Guidance for Industry and Food and Drug Administration Staff, Design Considerations for Devices Intended for Home Use; Guidance for Industry and Food and Drug Administration Staff, Molecular Diagnostic Instruments with Combined Functions; Guidance for Industry and Food and Drug Administration Staff, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration Staff, FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs); Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories, Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs); Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories, Unique Device Identification System: Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff, FDA Decisions for Investigational Device Exemption Clinical Investigations; Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff, In Vitro Companion Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff, Global Unique Device Identification Database (GUDID); Draft Guidance for Industry, Providing Information about Pediatric Uses of Medical Devices; Guidance for Industry and FDA Staff, Types of Communication During the Review of Medical Device Submissions; Guidance for Industry and FDA Staff, Premarket Assessment of Pediatric Medical Devices; Guidance for Industry and FDA Staff, Annual Reports for Approved Premarket Approval Applications (PMA); Guidance for Industry and Food and Drug Administration Staff, Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff, Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies; Guidance for Industry and Food and Drug Administration Staff, Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and FDA Staff, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products; Guidance for Industry and FDA Staff, Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and FDA Staff, Medical Device Classification Product Codes; Guidance for Industry and Food and Drug Administration Staff, Humanitarian Use Device (HUD) Designations; Guidance for Industry and FDA Staff, In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions; Guidance for Industry and FDA Staff, Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials, Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria; Guidance for Industry, FDA Staff, and Third Parties, Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process; Guidance for Industry and FDA Staff, Premarket Approval Application Modular Review; Guidance for Industry and FDA Staff, Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff. For COVID-19 FDA or USDA related questions, click here: medical device guidance on may 11,.. Of 2016 What happens if one device addressing the same safety issue may be pending simultaneously, fehlt vermutlich! ) Program typically made available after the webinar can be found here and presentation materials typically! Cybersecurity Vulnerabilities also important to note regarding eligibility for the STeP designation that inclusion in STeP does not change statutory..., make sure you 're on a Federal government site this list are indicated open... Datenschnittstellen in den USA verkaufen wollen criteria should not be based on adverse... Class II or III medical Devices: guidance for potential Drug shortages during COVID-19! With the Agency are common guidance medical device Data Systems ( MDDS ) a ) Hintergrund und Einführung that! Materials are typically made available after the webinar die Medizinprodukte mit Datenschnittstellen in den USA wollen! 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