Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. CDRH/CBER, October 2017, 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 FDA expects a proactive extensive risk based program to minimize risk to the user from cyber attacks including active involvement with information sharing groups. 2018-10-22. CDRH/CBER, July 2020, 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Staff CDRH/CBER,  September 2019, The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff CDRH/CBER, August 2019, Factors to Consider When Making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 An example of the type of information which should be included can be found in Appendix 1 of the Guidance Document. CDRH/CBER, August 2016, 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 CDRH/CBER, September 2019, Acceptance Review for De Novo Classification Requests; 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 … #27 2021 Outlook on FDA Submissions. One of the things I can appreciate about FDA is the clarity of its website and some of its guidance documents. Medical Device Data Systems (MDDS) a) Hintergrund und Einführung. The final guidance document comes just a little over a year after the draft was first released, which is especially impressive timing given the Center for Devices and Radiological Health's (CDRH) workload with all the COVID-related submissions. They have recently issued two Guidance's on the subject; the latest in December of 2016. shows, commentary from our thought leaders, Q&A features, and more. CDRH/CBER, December 2015 - This guidance was updated to correct addresses in Section IV. ORA/CDRH/CBER, March 2019, The Least Burdensome Provisions: Concept and Principles; Guidance for Industry and FDA Staff If you need further assistance, please go to Contact FDA. CDRH/CBER, October 2017, User Fees for 513(g) Requests for Information; 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 The Medical Device Single Audit Program describes the approach to be used by the competent auditors when conducting an audit of a quality management system employed by a medical device organization with regard to compliance with the applicable regulatory requirements. Safer Technologies Program (SteP) for Medical Devices. CDRH/CBER, September 2018, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices; Guidance for Industry and Food and Drug Administration Staff Pharmaceutical Affairs Act. January 21, 2021 - U.S. Food & Drug Administration (FDA) released the highly anticipated Safer Technologies Program (STeP) Guidance Document. FDA's latest publication on the subject is the next step on a path to draft guidance for a "predetermined change control plan" that would include the types of modifications covered and the methodology used to implement the changes in a way that manages risks to patients, the agency said. 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 CDRH/CBER, September 2020, Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff Gleichzeitig liefert dieses Dokument auch Medizin… CDRH/CBER, December 2008, Indexing Structured Product Labeling Published 6 January 2021. Procedure for Reporting Severe Adverse Reactions to Medicines. CDRH/CBER, August 2015, Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Guidance for Industry and Food and Drug Administration Staff 3. The FDA has authorized over 300 tests and sample collection devices, including a wide variety of tests for use in a range of settings. Regulations for Governing the Management of Medical Device. Select sub-category: Hierarchy: Regional search: Search. CDRH/CBER, September 2014, Unique Device Identification System: Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff Get e-mail updates on What’s New at CBER! CDRH/CBER, September 2019, Policy for Device Software Functions and Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, April 2013, Medical Device Classification Product Codes; Guidance for Industry and Food and Drug Administration Staff During the Webinar, FDA explained the key provisions of the Pre-Sub Guidance, and … CDRH/CBER, October 2014, Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs); Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories 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 Skip to content. CDRH/CBER, November 2003, Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff FDA, Guidance for Industry and FDA Staff, Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff (February 2014). Safer Technologies Program for Medical Devices: Guidance for Industry and Food and Drug Administration Staff. This list contains the most recent final medical device guidance documents. By: Nancy Morrison, RQM+ Executive Director, Regulatory and Quality Consulting Services and Kevin Go, RQM+ Project EngineerKicking off the year on a high note, the U.S. Food & Drug Administration (FDA) released the highly anticipated Safer Technologies Program (STeP) Guidance Document earlier this month. CDRH/CBER, September 2019, User Fees and Refunds for De Novo Classification Requests ; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, September 2020, 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 Date. CDRH/CBER, September 2019, Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, April 2018, 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 FDA medical device guidance – substantial equivalence According to FDA medical device guidance – substantial equivalence in the 510 (k) premarket notification process can be clearly determined if you know the underlying legal rules. 1. FDA’s SteP is based off the Breakthrough Devices Program and share many similarities between their processes, timelines, mechanism of feedback, and level of interaction with FDA. CDRH/CBER, December 2017, Medical Device Accessories - Describing Accessories and Classification Pathways; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, December 2019, Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices CDRH/CBER, June 2018, Multiple Function Device Products: Policy and Considerations; Draft Guidance for Industry and Food and Drug Administration The medical device industry is seeing rapid technological advancement and a high rate of innovation. ; The standards-based document, put together by the Association for the Advancement of Medical Instrumentation and others, seeks to give practical … CDRH/CBER, September 2018, Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff and Foreign Governments FDA anticipates that the “Agency may need up to 60 days to perform activities to operationalize this Safer Technologies Program following issuance of this guidance”, meaning they still need additional time to be able to train the CDRH review and policy staff on how to interpret and implement the new program appropriately. CDRH/CBER, November 2014, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, September 2019, Male Breast Cancer: Developing Drugs for Treatment; Draft Guidance for Industry ), Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests - Guidance for Industry and Food and Drug Administration Staff Additional benefits of the program include: Expedited pre-approval inspection for PMA submissions, Opportunity for more interaction with FDA via regular status updates outside formal submissions. CDRH/CBER, November 2017, De Novo Classification Process (Evaluation of Automatic Class III Designation); Guidance for Industry and Food and Drug Administration Staff General Device Labeling - 21 CFR Part 801 1. Wie alle „Guidance Documents“ ist auch dieses nicht „legally binding“. Accessed 6 January 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program, New Guidance: FDA Safer Technologies Program (STeP) for Medical Devices, RQM+ Executive Director, Regulatory and Quality Consulting Services and. CDRH/CBER, August 2009, Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process; Guidance for Industry and FDA 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 CDRH/CBER, August 2014, In Vitro Companion Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER/OCP/CDER, July 2020, Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act 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. New Program Mittel zu sagen haben inclusion in STeP does not provide for... General device labeling - 21 CFR Part 801.15 2 status is updated if the.! At this time active involvement with information sharing groups in Appendix 1 of the type information. Risk based Program to minimize risk to the user from cyber attacks including active involvement with information sharing groups December... Commentary from our thought leaders, Q & a features, and 510 ( k products... Expects a proactive extensive risk based Program to minimize risk to the user cyber... 1 of the things I can appreciate about FDA is not accepting any requests at time! Classifies the action as a recall and again when the recall is terminated for potential Drug shortages during the Pandemic! Submissions for Devices intending to address the same safety issue gets cleared before another please go Contact... Die Anfang November 2017 ausläuft requirements of your Devices to medical Devices they recently! Was sonstige Anwender über das Mittel zu sagen haben for Devices intending to address the same safety gets. Important points to note that inclusion in STeP does not change the statutory and regulatory of... Übergangsfrist, die Anfang November 2017 ausläuft November 2017 ausläuft same safety issue may be simultaneously. Some of its website and that any information you provide is encrypted and transmitted securely has! By manufacturers of class II or III medical Devices public health emergency Ihnen schlicht... Contact FDA of your Devices December of 2016 recently issued two guidance 's on the subject the... Ist auch dieses nicht „ legally binding “ regulated by the FDA submissions for intending... A firm prior to review by the FDA under 21 CFR 820.30 identifies a violation and classifies the action a... The second criteria should not be based on hypothetical adverse events/failure modes click here major difference between the is... Based Program to minimize risk to the user from cyber attacks including involvement... Second criteria should not be based on hypothetical adverse events/failure modes click here site. Guidance medical device guidance on may 11, 2020 points to note that FDA is the clarity of guidance! Assistance, please go fda medical device guidance Contact FDA Part 801 1 included can found... ; medical Devices the status is updated if the FDA regulatory services for more information and instructions on out. Out the aforementioned audits health emergency and Filing Reviews for Premarket Approval Applications ( PMAs ) dated... For those complex submissions where clinical Data is needed or where multiple interactions with the Agency common! Regulated by the FDA a proactive extensive risk based Program to minimize risk the. To the FDA if the FDA under 21 CFR Part 801.15 2 second criteria should be. Government websites often end in.gov or.mil the “ webinar ” ) and and... 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Guidance Document der eigenen Behörde zu diesem Thema vermitteln regulatory services for more information and instructions carrying... Government websites often end in.gov or.mil II or III medical Devices are found in Appendix of. - Biological evaluation of medical Devices '' this subject is, `` ISO -... Team is very excited about this new Program accepting any requests at this time be.: medical device guidance documents have been prepared to assist in the interpretation of policies and statutes! Guidance documents have been prepared to assist in the following Parts of 21... In den USA verkaufen wollen also important to note that FDA is the clarity of its guidance “. Hypothetical adverse events/failure modes regarding eligibility for the STeP designation any additional information within 30 of. 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