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, August 2016, Adaptive Designs for Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff eCopy Program for Medical Device Submissions; Guidance for Industry 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. Why you should Attend: Medical device cybersecurity has become very important to the FDA. 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 2017, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff Since January 2017, it may also include correction or removal actions initiated by a firm prior to review by the FDA. The major difference between the programs is in the eligibility criteria. The present guidance provides detailed information and instructions on carrying out the aforementioned audits. The criteria for a medical device or combination device to participate in the STeP is: Device is for less serious diseases or conditions and, consequently, is not eligible for the Breakthrough Devices Program, Reduction in known serious adverse events, Reduction in known use related hazard or use error, Improvement in safety of another device or intervention. January 21, 2021 - U.S. Food & Drug Administration (FDA) released the highly anticipated Safer Technologies Program (STeP) Guidance … 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, May 2014, Types of Communication During the Review of Medical Device Submissions; Guidance for Industry and FDA Staff This document supersedes Acceptance and Filing Reviews for Premarket Approval Applications (PMAs), dated December 31, 2012. CDRH/CBER, December 2018, Manufacturing Site Change Supplements: Content and Submission ; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, October 2017, Deciding When to Submit a 510(k) for a Software Change to an Existing Device; Guidance for Industry and Food and Drug Administration Staff 4. The .gov means it’s official.Federal government websites often end in .gov or .mil. Just like the FDA Breakthrough Devices Program, there is a commitment on the part of the sponsor to respond quickly to interactive review questions to take full advantage of this expedited program. CDRH/CBER, April 2019, Review and Update of Device Establishment Inspection Processes and Standards; Draft Guidance for Industry CDRH/CBER, February 2003. Verschieben wir gleichwohl unseren Blick darauf, was sonstige Anwender über das Mittel zu sagen haben. Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try searching for the document using the document title. Skip to content. CDRH/CBER, January 2018 - Document originally issued on May 1, 2003. An official website of the United States government, : CDRH/CBER,  September 2019, Refuse to Accept Policy for 510(k)s; Guidance for Industry and Food and Drug Administration Staff The medical device industry is seeing rapid technological advancement and a high rate of innovation. Outside of the U.S. a set of very similar regulations (nearly exactly … We follow and understand the changing regulatory landscape due to the COVID-19 Pandemic. It is also important to note that inclusion in STeP does not change the statutory and regulatory requirements of your devices. CDRH/CBER, August 2014, In Vitro Companion Diagnostic Devices; 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 The FDA has authorized over 300 tests and sample collection devices, including a wide variety of tests for use in a range of settings. FDA hosted a webinar to discuss this new medical device guidance on May 11, 2020. Das Guidance Document ‚Interoperable Medical Devices‘ wendet sich an Hersteller, die Medizinprodukte mit Datenschnittstellen in den USA verkaufen wollen. CDRH/CBER, December 2019, Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices “ should be out by the end of the fiscal year” said Christy Foreman, Director of the Office of Device Evaluation, in her testimony before the House Oversight. FDA Home; Medical Devices; Databases - This database contains Medical Device Recalls classified since November 2002. The site is secure. ©2020 REGULATORY AND QUALITY SOLUTIONS LLC (R&Q), Safer Technologies Program (STeP) Guidance Document, FDA is hosting a webinar on February 1, 2021, https://www.fda.gov/media/130815/download. Check out our Regulatory services for more information and learn more about RQM+ here. 1. Use of Symbols - 21 CFR Part 801.15 2. CDRH/CBER, September 2019, Policy for Device Software Functions and Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, June 2020, 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 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, August 2014, FDA Decisions for Investigational Device Exemption Clinical Investigations; Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff CDRH/CDER/CBER/CVM, December 2014, Design Considerations for Devices Intended for Home Use; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, November 2014, Molecular Diagnostic Instruments with Combined Functions; 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. CDRH/CBER, January 2019, Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products; Draft Guidance for Industry New Guidance: FDA Safer Technologies Program (STeP) for Medical Devices Upcoming and on-demand education, commentary from thought leaders, Q&A features, and more. CDRH/CBER, September 2019, The Abbreviated 510(k) Program; 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 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 CDRH/CBER, April 2013, Medical Device Classification Product Codes; Guidance for Industry and Food and Drug Administration 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). CDRH/CBER, June 2018, Multiple Function Device Products: Policy and Considerations; Draft Guidance for Industry and Food and Drug Administration For COVID-19 FDA or USDA related questions, click here . CDRH/CBER, October 2017, User Fees for 513(g) Requests for Information; 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 CDRH/CBER, August 2017, 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 They provide similar examples in the Breakthrough Guidance, so it is possible that something similar will happen where the benefit-risk for the devices still under review will have to be adjusted after the first one is cleared, or they may end up being disqualified. 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