Skip to main content

What to include in Traditional 510(k) Filing for Medical Devices

BayBiotech.NET
A 510k is a premarket submission made to FDA to demonstrate that a medical device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.
A Traditional 510(k) submission must include the required elements as per 21 CFR 807.87 (Information required in a premarket notification submission):
 the name of device, (the trade or proprietary name), if any, and the common or usual name or classification name of the device.
 description of the device, include device specifications and reference applicable guidance documents, special controls, or standards; photographs or engineering drawings should be supplied, if applicable.
 comparison with a predicate device(s), indicating similarities and/or differences accompanied by data, as appropriate; this information may include an identification of materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device.
 intended use of the device,
 proposed label, labeling, and advertisements for the device and directions for use.
 Information on sterilization, biocompatibility, expiration date, etc., if applicable.
Important elements of a Traditional 510(k) filing include:
• Medical Device User Fee Cover Sheet (Form FDA 3601).
• CDRH Premarket Review Submission Cover Sheet
• Certification of Compliance with ClinicalTrials.gov Data Bank, FDA-3674
• Cover letter
• Table of Contents (recommended)
• Indications for Use
• 510(k) Summary (21 CFR 807.92) or 510(k) Statement (21 CFR 807.93)
• Standards Data Report for 510(K) s - FDA 3654. Submit this form if your 510(k) references a national or international standard.
• Truthful and Accuracy Statement (21 CFR 807.87(k))
• Class III Certification and Summary for Class III devices (21 CFR 807.94)
For more details on the procedure and forms visit official FDA website at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070202.htm

Comments

Post a Comment

Popular posts from this blog

A Facility Inspection Checklist

BayBiotech.NET Whether you are a Quality Assurance/ Compliance personnel planning to make a visit for a facility inspection, this checklist will help you prepare an inspection report based on the information that might be required to collect about the facility during the inspection. This checklist may help you evolve different forms for the inspection in order to accumulate complete information about the facility: 1.General information (a) name of establishment inspected (b) date of inspection (c) name(s) of the inspector(s) (d) date of last inspection. 2.Type of inspection Comprehensive, concise, follow-up, special, investigative, announced, and unannounced. 3.Licensing (a) licensing of premises (b) person with supervisory role in establishments (c) adherence to licensing provisions. 4. Activities undertaken on premises manufacturing, wholesale, importation, export, retail, hospital, pharmacy, clinic, nursing and maternity homes. 5. Adequacy and suitability of pre...
1 comment
Read more

Group C (Treatment IND) Drugs

BayBiotech.NET Since 1976, National Cancer Institute (NCI) in agreement with FDA has established the Group C classification system to allow access to certain drugs for the cancer patients specifically falling under a category that adequate alternative therapy or if the available alternative therapy has significant toxic effects. Each Group C drug protocol specifies patient eligibility and drug use information. Group C drugs are provided only to properly trained physicians who have registered themselves with NCI using a special form to assure that their patient qualifies under guidelines - or protocols - for the drug. Physicians using drugs under Group C have no reporting requirements to the NCI other than the obligation to report adverse drug reactions. Group C drugs are provided free of charge, and the Centers for Medicare and Medicaid Services provides coverage for care associated with Group C therapy. Making Group C drugs available to the critically ill patients not only provi...
Post a Comment
Read more

FDA Launches Medical Device and Radiation-Emitting Product Transparency Web Site

BayBiotech.NET On April 19th, 2010 FDA launched he Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative. The Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format. The site includes new information such as basic information about medical devices and how FDA regulates those products, information about medical devices before and after the products are on the market, in a searchable database, information about the clinical studies and trials conducted to demonstrate the safety and effectiveness of certain medical devices, memos from FDA employees explaining the reasons for the agency's decisions about medical device manufacturer requests to make a significant change in components, materials, design, specification, software, color additive, and labeling of a medical device as well as a step-by-step guide for manufacturers of...
1 comment
Read more