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

Good Machine Learning Practices

BayBiotech.NET A joint effort by FDA,  United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada have developed guiding principles to help promote utilization of medical devices that are safe and effective and utilize artiificial intelligence and machine learning. To find out more details check out the link here!
Post a Comment
Read more

Food Safety Bill: A major overhaul of the Food Safety System

BayBiotech.NET The recently passed Food Safety bill is being considered to be a major overhaul of the food safety system in the United States and is considered to change the mission of the FDA, focusing it on preventing food-borne illnesses rather than reacting after an outbreak occurs. Under this legislation, food manufacturers are required to examine their processing systems to identify possible ways that food products can become contaminated and to develop detailed plans to keep that from happening. Companies must share those plans with the F.D.A., and provide the agency with records, including product test results, showing how effectively they carry them out. To read more about it follow the link
Post a 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