Manufacturers must establish and follow quality system to help ensure that their products consistently meet applicable requirements and specifications. The Quality System regulation is a quality assurance requirement that covers the design, packaging, labeling and manufacturing of a medical device.
Sterling Medical Registration will establish for you a quality system that will meet FDA regulations and meet your needs.
Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k)to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act.
Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent to a legally marketed device that is not subject to PMA.
You must note that if your device requires the submission of a Premarket Notification 510(k), you cannot commercially distribute the device until you receive a letter of substantial equivalence from FDA authorizing you to do so.
Classification is risk based, the risk that device poses to the patient and/or the user is a major factor in the class it is assigned.
Class I includes devices with the lowest risk and Class III includes those with the greatest risk.
Classification identifies the level of regulatory control that is necessary to assure the safety and effectiveness of a medical device.
All classes of devices as subject to General Controls. General Controls are the baseline requirements of the Food, Drug and Cosmetic (FD&C) Act that apply to all medical devices, Class I, II, and III.
Medical Devices are subject to the general controls of the Federal Food Drug & Cosmetic (FD&C) Act which are contained in the final procedural regulations in Title 21 Code of Federal Regulations Part 800-1200 (21 CFR Parts 800 - 1299). These controls are the baseline requirements that apply to all medical devices necessary for marketing, proper labeling and monitoring its performance once the device is on the market. On September 2013 The Food and Drug Administration (FDA) has released a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. It also applies to certain combination products that contain devices and to devices licensed under the Public Health Service (PHS) Act (e.g., donor screening assays).
The Final Rule:
The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA's Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety. In developing the proposed UDI system, the FDA worked closely with industry, the clinical community and patient and consumer groups, and conducted four pilot studies.
A UDI is a unique numeric or alphanumeric code that consists of two parts:
(1) a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and
(2) a production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
the lot or batch number within which a device was manufactured;
the serial number of a specific device;
the expiration date of a specific device;
the date a specific device was manufactured;
the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application.
Once clearance for marketing has been obtained for the medical devices, then the manufacturer must register their establishsment.
Cleared medical devices must also be listed with the FDA database.
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).
The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.
International partners that are participating in the MDSAP include:
From 01 January 2014 to 31 December 2016, FDA, alongside its international partners, participated in a Medical Device Single Audit Program Pilot. On 29 June 2017, a report was generated summarizing the outcomes of prospective “proof-of-concept” criteria established to confirm the viability of the Medical Device Single Audit Program. The outcomes documented in the Final MDSAP Pilot Report are based on data generated during the three (3) year pilot.
Based on its evaluation of the MDSAP Final Pilot Report, the MDSAP Regulatory Authority Council (the international MDSAP governing body) determined that the MDSAP Pilot had satisfactorily demonstrated the viability of the Medical Device Single Audit Program.
FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections. Firms with activities related to the Electronic Product Radiation Control (EPRC) provisions of the Act will continue to be subject to FDA inspections for the EPRC activities
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.
Sterling Medical Registration provides U.S Agent and Official Correspondent services to foreign and U.S local companies.
Medical Devices must comply with the FDA labeling regulations prior to marketing the device.
Our Labeling consulting services include editing and preparation of label & symbols design, intended use, instruction for use, packaging design and more.
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Further information related the Updated Compliances Dates for FDA UDI Requirements
Our consulting services included with clear guidance for the preparation of your 510k file submission.
We will provide you with a list of requirements and technical documentation that are required for the preparation of your 510k file.
We will guide you and support you through the entire process.
We will review your documentation and if they will be found to be not sufficient, we will do the necessary updates for you.
Once your 510k file submission is compiled we will coordinate the payment of FDA 510(k) submission fee.
We will submit your 510(k) to the FDA and be available as your official correspondent to answer follow-up questions from the FDA reviewer.
The FDA Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident.
On February 14,2014, FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit MDRs in an electronic format (the “Final Rule”). The Final Rule does not materially change the underlying requirements for reporting MDRs. It simply requires reporting of the information electronically as an electronic MDR (or eMDR).
The Agency believes that electronic submission of MDRs will improve its ability to collect and analyze such reports as it will make the information available more quickly. Sterling Medical Registration © 2013 | All Rights Reserved
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