Fda medical device searchable database. FDA Home; Medical Devices; Databases - 1 to 10 of 500 Results * 1 2 3 * The maximum 500 records meeting your search criteria returned. 1-888-INFO-FDA (1-888-463-6332) Contact FDA Search by Part and Section Number- Enter the entire number in the format shown (e. Please narrow your search. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness Dec 7, 2023 · The intention of this tool is to expand access of FAERS data to the general public to search for information related to human adverse events reported to the FDA by the pharmaceutical industry Search FDA Submit search. it includes links to the device summary information, manufacturer, approval date, user instructions, and Searchable databases of devices previously approved for marketing or declared substantially equivalent to a legally marketed device. These products are on the list because there is a reasonable chance that they could cause serious health problems or death. Overview page of Inpections Classifications database. You can search the TPLC database by device name or procode Jul 27, 2023 · Mandatory Medical Device Reporting Requirements. Reports older than ten years are provided on the FDA's MDR Data Files 32 webpage. to search, enter a single word (e. You can use the Test Type drop down box to select a Type of Test. Sep 9, 2024 · In 1997, the Food and Drug Administration Modernization Act (FDAMA) added the De Novo classification pathway under Section 513(f)(2) of the FD&C act, establishing an alternate pathway to classify new devices into class I or II that had automatically been placed in class III after receiving a Not Substantially Equivalent (NSE) determination in response to a 510(k) submission. g. Sep 9, 2024 · This database includes: a list of all medical devices with their associated classifications, product codes, FDA Premarket Review organizations, and other regulatory information. IMPORTANT DISCLAIMER. This search cannot be combined with any other search. FDA determines The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. , acme analyzer). For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. . May 13, 2024 · Center for Biologics Evaluation and Research (14); Center for Devices and Radiological Health (564); Center for Drug Evaluation and Research (54); Center for Food Safety and Applied Nutrition (7 . Oct 3, 2022 · Introduction. Nov 21, 2022 · FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. A search query will produce information from the database in the following format: This database includes: medical device manufacturers registered with FDA and; medical devices listed with FDA; Note: Registration of a device establishment, assignment of a registration Aug 31, 2024 · The Manufacturer and User Facility Device Experience (MAUDE) database is a searchable database of medical device reports (MDRs) of adverse events involving medical devices over the Sep 9, 2024 · Devices@FDA is a catalog of cleared and approved medical device information from fda. and monitors the safety of all regulated medical products. Search the Registration & Listing database. Apr 1, 2024 · When a medical device violates FDA law, FDA can take action to enforce compliance and ensure public health. 1-888-INFO-FDA (1-888-463-6332) Contact FDA Sep 9, 2024 · Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Since January 2017, it may also include correction or removal actions initiated by a firm prior to review by the FDA. to search by product name, class, date initiated, reason for recall or recalling manufacturer select go to advanced search button. Nov 6, 2023 · Browse and Search for 510(k) Clearances. This search Sep 9, 2024 · This database provides the most up-to-date list of voluntary consensus standards to which FDA will accept a Declaration of Conformity for medical devices. Aug 28, 2023 · FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 140,000 labeling documents for FDA-approved drug products, including Aug 31, 2024 · The Manufacturer and User Facility Device Experience (MAUDE) database is a searchable database of medical device reports (MDRs) of adverse events involving medical devices over the last ten years. Sep 9, 2024 · Databases A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. The format of any single observation begins with a statement based in a citation of law, regulation or Sep 9, 2024 · Enter any combination of fields and select Search. Nov 6, 2023 · Postamendments devices that FDA determines are substantially equivalent to preamendments Class III devices are subject to the same requirements as the preamendments devices. 1385) Full Text Search : CFR Title 21 - Food and Drugs: Parts 1 to 1499 Search FDA Submit search. Although you can comment on any guidance at any time (see 21 CFR 10. These data sets were created to provide public information regarding the various findings that result from inspections. 115(g)(5)), to ensure that the Agency considers your Aug 21, 2023 · The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). ) are required to Nov 1, 2002 · 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. Search the 510(k) Premarket Notification database. - from manufacturing through distribution to Summaries of information about the most serious medical device recalls. Please be aware of the following when using information from this Web site: The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug Administration (FDA). Jun 12, 2024 · These medical device reports have been available in the FDA's public Manufacturer and User Facility Device Experience (MAUDE) database since 1999 as one source of information to help patients and Jul 24, 2024 · Center for Biologics Evaluation and Research (14); Center for Devices and Radiological Health (605); Center for Drug Evaluation and Research (53); Center for Food Safety and Applied Nutrition (7 Jun 21, 2024 · For questions or issues related to the Searchable Tobacco Products Database, email SearchTobacco@fda. The Food and Drug Administration (FDA) conducts inspections and assessments of regulated facilities to determine a firm's compliance with Jun 21, 2019 · Information about the Adverse Event Reporting Data Files including Manufacturer and User Facility Device Experience (MAUDE) data and Medical Device Reporting (MDR) data. Please include a submission tracking number (STN) in the subject line if you are Mar 20, 2024 · Observations are listed on an FDA Form 483 in order of risk significance by the investigator. Search FDA Submit The CDRH Inspections Database Aug 28, 2024 · Overview of Medical Device Reporting. , electromechanical and infusion). After FDA has decided to recognize a standard, we will update our online database to reflect the decision even before formal recognition of the standard occurs by publication in the Federal The FDA uploads these into the MAUDE database and includes an additional statement in the narrative stating, "This report reflects information received by FDA in the form of a notification per 803 Oct 5, 2023 · Our Medical Device Product Classification database lists over 6,000 types of medical devices regulated by FDA's Center for Medical Devices and Radiological Health (CDRH) and the classification The FDA 510(k) database contains all devices cleared under the 510(k) process. Featured. , electromechanical pump) or multiple words connected by and (e. Each year, the FDA receives over two million medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. 510(k) Devices Cleared in 2023 Nov 29, 2023 · Owners or operators of places of business (establishments) that are involved in the production and distribution of medical devices intended for use in the United States (U. hhs. Inactive Ingredient Search for Approved Drug Products. Section (e. 5 days ago · This database contains Medical Device Recalls classified since November 2002. During an inspection, ORA investigators may observe conditions they The FDA considers a product to be a device, and subject to FDA regulation, if it meets the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act. The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user On January 21, 2009, President Obama issued the Open Government Initiative. Each person who wants to market in the U. Establishment Registration and Medical Device Listing Files for Download. CDRH maintains searchable databases on its 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. You can type the exact name of a specific device or a generic Sep 9, 2024 · Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. , electromechanical), an exact phrase (e. , analyzer) or an exact phrase (e. 6 Search FDA Submit search. The FDA is establishing the unique device identification system to adequately identify devices sold in the U. Sep 6, 2023 · The FDA's Medical Device Safety Action Plan outlines a vision for how the FDA can Is refreshed as individual databases are updated. This Some FDA guidance documents on this list are indicated as open for comment. Product classification; 510k Premarket Sep 9, 2024 · This database includes: medical device manufacturers registered with FDA and; medical devices listed with FDA; Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA. The status is updated if the FDA identifies a violation and classifies the action as a recall and again when the recall is terminated. An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). S. Medical Devices; Radiation-Emitting Products; Vaccines, Blood, and Biologics Postmarketing Requirements and Commitments Searchable Database Dec 6, 2023 · Introduction to Master Files for Devices (MAFs) A premarket approval application (PMA) or an investigational device exemption application (IDE) usually contains data and other information that the Mar 3, 2021 · Go to the Devices@FDA Database. Releasable establishment registration and listing information under You can search the releasable 510 (k) database by Panel, 510 (k) number, Product code or Device name. Mar 22, 2024 · The information on this page is current as of Mar 22, 2024. , 862. Once you have found the classification of your device, you should begin your search in the 510(k) database. Database provides ability to AccessGUDID is a searchable database of device identification information, such as the device identifier on the label, device name, company name, MR safety status, Global Medical Device Mar 22, 2024 · Title21 Part. gov. Search the database by: Medical Devices; The FDA maintains several publicly accessible databases that may be of particular interest to sponsors and manufacturers of neurological devices including:. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. For Test Name and Manufacturer: enter a single word (e. Sep 9, 2024 · This database includes: a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information. FDA regulates the sale of medical device products in the U. Databases. In the Enter a search term in the space below field, type the name of the device or the company name. 1325) and select Search Regulations. 05/10/2024: First Street, Gelson The FDA conducts inspections of medical device manufacturers to check that they are complying with medical device regulatory requirements. We would like to show you a description here but the site won’t allow us. Browse for Clearances by Year. , a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510 Sep 10, 2024 · This database contains the classified Medical Device Recalls since november 1, 2002. Report a Product Problem; Contact FDA; Medical Devices : Reports of patient burn injuries : Megadyne Medical Products Inc. Contact FDA; (CDC) prior to January 31, 2000 or by the FDA since that date. oiuowibtfnxbkmoqhxoanhuatrahqafendrnqpzlgibnxkbmmed