Information Required in a 510(k) Submission
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This PDF will discuss the key information that is required for a medical device 510k submission. The information presented in this PDF pertains to just one of the many best practices in a medical device 510K preparation and submission.
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![Information Required in a 510(k) Submission
Under 21 CFR 807.87
• The device name, including both the trade or proprietary name and the
common or usual name or classification name of the device.
• The establishment registration number, if applicable.
• The class and, if known, its appropriate panel [e.g., Dental (76)]
• Action taken for performance standards
• Proposed labels, labeling, and advertisements sufficient to describe the
device, its intended use, and the directions for its use. Where applicable,
photographs or engineering drawings should be supplied.
• A statement indicating the device is similar to and/or different from other
products of comparable type in commercial distribution (an identification
of similar products, materials, design considerations, energy expected to
be used or delivered by the device, and a description of the operational
principles of the device).
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Streptomirus (Streptovancin) is a new treatment for necrotizing fasciitis (NF) developed by Catalent Pharmaceutical Inc. Non-clinical studies in mice and dogs showed Streptomirus was safer, faster-acting, and more effective than current NF treatments. Clinical trials confirmed Streptomirus' efficacy and safety profile. Catalent is seeking FDA approval to market Streptomirus globally as an orphan drug for NF, an unmet medical need with high mortality. If approved, Streptomirus would provide a more effective treatment option for NF patients.
Fda adverse event reporting requirements for otc drugs
ComplianceOnline webinar on regulatory requirements for adverse event reporting for dietary supplements and OTC products
Regulation of Medical Devices in US
The document discusses the regulation of medical devices in the United States. It begins by defining what constitutes a medical device according to the Code of Federal Regulations. It then outlines the key regulatory bodies that oversee medical devices, including the Center for Devices and Radiological Health and the Office of Combination Products. The document provides an overview of the classification system for medical devices and the different regulatory pathways for approval, including 510(k) premarket notification, investigational device exemptions, premarket approval, and humanitarian device exemption. It also summarizes the key requirements and processes for each approval pathway.
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
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Regulatory strategy for medical device start-ups
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Marketing Strategy for a medical device company
This is a marketing strategy for a leading medical device company for a new product launch. This presentation won the Babson Marketing Case Competition - 2012 with prize money of $5000. 16 schools across the globe were competing in this competition.
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Similar to Information Required in a 510(k) Submission
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Session C3 - IVDs: Post-market responsibilities (I)
Presented by:
Sally Jennings, RA QA Affairs & IBP Manager, Abbott Diagnostics
Myriam Battistutta, Senior Consultant, Quality & Regulatory Affairs, Fusidium
Irina Tsyganova, Director, Devices Application & Verification, Office of Devices Authorisation, TGA
Poster Presentation - FDA Compliance Landscape & What it Means to Your AI Asp...
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Premarket Notification 510(k) for Biologics [Autosaved].pptx
The document summarizes the key aspects of the 510(k) premarket notification process for biologics. It explains that 510(k) is required to market a new device and demonstrates substantial equivalence to a legally marketed predicate device. The submission must include device descriptions, intended use, and clinical/nonclinical test results. There are three types of 510(k) submissions. The process involves FDA review within 90 days to determine substantial equivalence or request additional information. If cleared, the product can be marketed immediately.
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Let us now have a look at the FAA SAVES Federal contract requirements in terms of the technical requirements:
DEPARTMENT OF HEALTH & HUMAN SERVICES .docx
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Center for Devices and Radiological Heath
Office of Communication, Education and Radiation Programs
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Watson Megatech, Inc.
% Chad Watson
Dec 1, 2011
President and CEO
5800 Industrial Blvd
Suite 11
Omaha, NE 68135
Re: P091462
BioBanking
Filed: Jan 9, 2010
Amended: August 5, September 8 and 13, 2010; February 22, 2011; September 22, 2011; October 6, 2011 and November 1, 2011.
Procode: RLD
Dear Mr. Watson:
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration
(FDA) has completed its review of your premarket approval application (PMA) for the BioBanking Device.
BioBanking is intended to be for sub-dermal use as a radio frequency (RF) emitter in the prevention of identity theft and financial fraud. The device will interact with external scanners through radio frequency to identify the individual as well as financial account information. The device will also interact with external encoders for the purposes of addition or removal of financial account information. The device is solar powered and does not need internal batteries that would provide potential medical issues in the PMA review process.
The BioBanking insertion process can be administered by non-medical personnel trained in the implementation of the product. Financial institution personnel responsible for this administration will be trained and certified in application of the BioBanking device.
The sub-dermal BioBanking device is one element of the total transaction system. There is also a reader for the RF signals. Since the reader is a passive device it does not fall under provisions of the CDRH purview.
We are pleased to inform you that the PMA is approved. You may begin commercial distribution
of the device in accordance with the conditions of approval described below. You may continue
commercial distribution of the device upon receipt of this letter.
Page 2 – Mr. Watson
The sale and distribution of this device are governed by The Radiation Control provisions (originally enacted as the Radiation Control for Health and Safety Act of 1968) located in Sections 531 through 542 of the Act. They apply to any "electronic product" which is defined as: any manufactured or assembled product (or component, part, or accessory of such product) which, when in operation,
i. contains or acts as part of an electronic circuit and
ii. emits (or in the absence of effective shielding or other controls would emit) electronic product radiation.
"Electronic product radiation" is defined as:
i. any ionizing or non-ionizing electromagnetic or particulate radiation, or
ii. any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product.
The device is restricted under section 515(d)(l)(B)(ii) o.
Scope of work and terms and conditions fin al
The document outlines the scope of work, terms and conditions for procuring All-In-One PCs. It includes:
- A 5-year comprehensive on-site warranty for all supplied hardware and software.
- Delivery within 2 months and installation within 1 month of delivery.
- Payment in two parts: 70% after installation, 30% in 20 quarterly installments during the warranty period.
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- 5 years of on-site maintenance and support provided by the bidder.
FDA regulation for medical devices
This document provides an overview of FDA regulation of medical devices in the United States. It defines key terms, describes the classification system for devices and corresponding levels of regulatory control. It outlines major premarket and postmarket requirements including establishment registration, 510(k) premarket notification, premarket approval, labeling, quality system regulation, medical device reporting and complaint handling. Major sections cover classification, premarket submissions, labeling and other compliance requirements enforced by the FDA to ensure device safety and effectiveness.
South Korea medical device approval chart - Emergo
The regulatory process for medical devices in South Korea requires manufacturers to determine the classification of their device and submit the appropriate registration application and supporting documentation to the Ministry of Food and Drug Safety (MFDS). For new devices without a predicate, manufacturers must submit clinical data as part of a Clinical Data Review. Class II devices considered "Special Equivalent" have an expediated review process without a Technical File requirement. Prior international testing may satisfy some requirements but additional Korea-specific testing is often necessary. The MFDS may request additional information or audit submissions, extending approval timelines.
Latest update USA Regulations By P.Trisler Qserve Group (Qserve Conference 20...
Latest update USA Regulations By P.Trisler Qserve Group (Qserve Conference 20...qserveconference2013
The document provides an overview of new and updated FDA regulations and processes for medical devices. It summarizes FDA classification systems and approval pathways, including new Refuse to Accept and electronic copy submission requirements. It also outlines changes to the de novo and pre-submission processes, as well as new guidance on Unique Device Identification and international symbols.De-Novo Classification.pptx
This document discusses de novo classification, a process that allows the FDA to classify new medical devices that are not equivalent to existing Class I or II devices. It describes how de novo classification works, the conditions for obtaining it, and what must be included in a de novo request. Key points are that de novo allows classification of low to moderate risk devices without a 510(k), and a request can be submitted after receiving a 510(k) "not substantially equivalent" decision or if there is no predicate device. The FDA reviews requests to determine appropriate classification and whether general or general/special controls provide reasonable safety and effectiveness assurances.
US FDA medical device approval chart - Emergo
Simple one page chart shows the US FDA medical device approval process for Class 1, 2 and 3 devices. Very easy to understand.
Regulatory 101
Many emerging companies make the mistake of putting all of their resources into immediate needs, and often neglect longterm regulatory strategy concerns when it comes to submissions and approvals. Don’t neglect the strategy piece in your planning! This lunch will provide a deep-dive foundation of how to develop a regulatory strategy. Topics to be addressed include:
What are different types of regulatory submissions for devices?
What are current trends in regulatory agencies?
What regulations around devices affect your organization?
Attendees will have the opportunity to ask questions with their company’s needs in mind.
Join us and Halloran Consulting at M2D2 for this expert lunch. Food will be served.
2024: The FAR, Federal Acquisition Regulations - Part 11
Jennifer Schaus and Associates hosts a complimentary webinar series on The FAR in 2024. Join the webinars on Wednesdays and Fridays at noon, eastern.
Recordings are on YouTube and the company website.
https://www.youtube.com/@jenniferschaus/videos
Validation
This document discusses equipment validation which establishes that equipment operates consistently and produces products meeting specifications. It defines validation as a program providing high assurance that a process will consistently produce products meeting requirements. The importance is reducing quality costs, optimizing processes, and ensuring safety. Validation involves specifying user requirements, designing equipment, installing, operating, and performing qualification tests to ensure equipment functions as intended under normal use. It provides a framework for validating equipment used in the pharmaceutical industry.
Presentation: Update from the Medical Devices Branch
Under Recommendation 15 of the Review of Medicines and Medical Review Regulation (MMDR) the Government agreed to greater utilisation of marketing approvals by comparable overseas regulators to support assessments of medical devices in Australia. Legislative amendments in the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 to enact this change also included clarifications regarding preliminary assessment of applications for pre-market authorisation. This presentation will review the implementation arrangements for these changes, covering the increased options for use of overseas approvals, and the evidence requirements to support applications.
Overview of 510k application mdrfda
Different parts or sections included into the 510k application for class 2 medical device regulatory approval
medical device regulatory approval in USA
The document discusses the approval process for medical devices in the United States, including an overview of the classification system for medical devices (Class I, II, III), the requirements for each class (e.g. 510(k) notification or premarket approval), and the components required for a 510(k) premarket notification application to the FDA.
Medical device regulations
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
Premarket Notification The 510(k) Process
June 5, 2012 presentation to the Food & Drug Law Institute Introduction to Medical Device Law Conference, Palo Alto, CA, focusing on:
I.The Legal Framework For 510(k) Determinations
II.510(k) Preparation – From Planning to Content
A. Predicates: researching predicates, combination predicates, and pre-amendment predicates
B. Strategy: choosing the right claim and introducing new features
C. Assessing data requirements/pre-IDE meetings
III. Device Modifications - Choosing The Right Regulatory Mechanism
IV.The FDA Review
V.What To Do When Your Substantial Equivalence Argument Is Rejected
V. Special Topics: User Fees, Combination Products
VI. Lessons Learned: Seeing The 510(k) From The Reviewer’s Perspective
VII. Recent Trends, 510(k) Reform
VIII. Case Study
Pakistan Medical Device regulatory process
Medical devices in Pakistan are regulated by the Medical Device & Medicated Cosmetics Division and must be classified according to the Medical Device Rules of 2017. The regulatory process involves appointing a registered importer, determining the classification, and having an authorized representative submit an application dossier and fees to the Medical Devices Board for approval. Approval times range from less than two months for Class A local manufacturer devices to 8-10 months for Class D imported devices not from reference countries.
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Sponsor Information and Training day Session C3 - IVDs: Post-market responsib...
Sponsor Information and Training day Session C3 - IVDs: Post-market responsib...
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Poster Presentation - FDA Compliance Landscape & What it Means to Your AI Asp...
Premarket Notification 510(k) for Biologics [Autosaved].pptx
Premarket Notification 510(k) for Biologics [Autosaved].pptx
Technical Functional Requirements every Contractor must adhere to before Appl...
Technical Functional Requirements every Contractor must adhere to before Appl...
South Korea medical device approval chart - Emergo
South Korea medical device approval chart - Emergo
Latest update USA Regulations By P.Trisler Qserve Group (Qserve Conference 20...
Latest update USA Regulations By P.Trisler Qserve Group (Qserve Conference 20...
2024: The FAR, Federal Acquisition Regulations - Part 11
2024: The FAR, Federal Acquisition Regulations - Part 11
Presentation: Update from the Medical Devices Branch
Presentation: Update from the Medical Devices Branch
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Information Required in a 510(k) Submission
- 1. This Training is Brought to you by ComplianceOnline. www.complianceonlie.com ©2010 Copyright © 2014 ComplianceOnline This training session is sponsored by 1 US FDA 510(k): Best Practices for 510(k) Preparation and Submission
- 2. Information Required in a 510(k) Submission Under 21 CFR 807.87 • The device name, including both the trade or proprietary name and the common or usual name or classification name of the device. • The establishment registration number, if applicable. • The class and, if known, its appropriate panel [e.g., Dental (76)] • Action taken for performance standards • Proposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use. Where applicable, photographs or engineering drawings should be supplied. • A statement indicating the device is similar to and/or different from other products of comparable type in commercial distribution (an identification of similar products, materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device). www.complianceonline.com ©2014 Copyright 2
- 3. Information Required in a 510(k) Submission (Cont.) Under 21 CFR 807.87 (Cont.) • A device that has undergone a significant change or modification that could significantly affect the safety or effectiveness of the device, or the device is to be marketed for a new or different indication for use (MUST include appropriate supporting data to show that the manufacturer has considered what consequences and effects the change or modification or new use might have on the safety and effectiveness of the device). • A 510(k) summary as described in 807.92 or a 510(k) statement as described in 807.93. • A financial certification or disclosure statement or both. • The 510(k) submitter shall also certify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (class III certification), as described in 807.94. FDA may require the submission of the adverse safety and effectiveness data described in the class III summary or citation. www.complianceonline.com ©2014 Copyright 3
- 4. Information Required in a 510(k) Submission (Cont.) Under 21 CFR 807.87 (Cont.) • A statement that the submitter believes, to the best of his or her knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted. • Any additional information regarding the device requested by the Commissioner to make a finding as to whether or not the device is substantially equivalent to a device in commercial distribution. A request for additional information will advise the owner or operator that there is insufficient information contained in the original premarket notification submission for the Commissioner to make this determination and that the owner or operator may either submit the requested data or a new premarket notification containing the requested information at least 90 days before the owner or operator intends to market the device, OR submit a PMA application in accordance with section 515 of the act. If the additional information is not submitted within 30 days following the date of the request, the Commissioner will consider the premarket notification to be withdrawn. www.complianceonline.com ©2014 Copyright 4
- 5. For more information on Live Webinars and any Other Training Requirements please email us webinarassist@complianceonline.com or Call us at this Toll Free Number: 1- 888-717-2436 Register - http://www.complianceonline.com/510-k-submission-webinar-training-701016-w?channel=Docs-Sharing www.complianceonline.com ©2014 Copyright 5