Manufacturers of Medical Devices are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction was to be reoccur. The Medical Device Reporting (MDR) regulation (21 CRF 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their components that are used to produce or assemble the final device may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to reoccur.
Why Should You Attend
The FDA expects health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality, and therapeutic failures. The overall intent of this webinar, just like FAA for passenger safety is to provide critical information that helps improve patient safety.
Areas Covered in this Webinar
As mentioned above, the FDA encourages healthcare professionals, patients, caregivers and consumers to submit voluntary reports of significant adverse events or product problems with medical products to MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.
We are going to talk at length about Customer Complaints a little later in this webinar. Each manufacturer must establish and maintain procedures to control all documents that are being used for the generation and distribution of medical devices. To meet Quality System guidelines (expectations, regulations, etc.) , procedures need to provide but not limited to the following:
1 Medical device reports are submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients, caregivers and consumers).
(a) Document approval and distribution. Each manufacturer need to designate an individual(s) to review for adequacy and approve prior to issuance the documents generated to meet the requirements of the Quality System generated to be compliant with 21 CRF 820. The approval, including the date and signature of the individual(s) approving the document, are to be documented. Documents established within a company should be available at each location within the company as applicable, important to know and understand the difference between Policies, Practices (internal guidelines) and Procedures. Procedures require documented evidence of compliant performance by operators
2 (b) Document changes. Changes to documents are to be reviewed and in accordance with the implemented Change Control Program. Document changes require notification and related training. Change control records must include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective
3 Evaluation of suppliers, contractors, and consultants. Each manufacturer is required to establish and maintain the requirements, including quality requirements as well as a quality agreement that must be met by suppliers, contractors, and consultants. Each manufacturer is expected to:
1. Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation must be documented in accordance with cGMP/GDP
2. Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results
3. Establish and maintain records of acceptable suppliers, contractors, and consultants
4 How parties involved in the contract manufacturing of drugs or medical devices can utilize Quality Agreements to delineate their responsibilities and assure product quality, safety, and efficacy. This guidance applies to the commercial manufacturing of FDA regulated raw materials, final product components, intermediates, combination products or final products. For the purposes of generating the agreement, the term “manufacturing” includes processing, assembly, packing, holding, labeling operations, testing, and operations of the vendor’s Quality Unit
5 Purchasing data. Each manufacturer must establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents typically include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device
6 Identification - 820.60 - Each manufacturer must establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mix ups
7 Traceability - 820.65 - Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user are required to establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures are intended to facilitate corrective action. Such identification is to be documented in the DHR
8 Control of nonconforming product. Each manufacturer must establish and maintain procedures to control product that does not conform to specified requirements. The procedures are required to address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance must include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation has to be documented
9 CAPA - Before non-conformance or deviations are discovered, we also have to have an Incident Tracking system, which is used to determine when Corrective Action or Preventative Action needs to be applied – Quality Evaluation, Investigation, Root Cause Analysis, Change Management, Effectiveness Monitoring and Acceptance
10 Each manufacturer is required to maintain a quality system record (QSR) for each batch or lot. The QSR will include, or refer to the location of, procedures and the documentation of activities required for the production of the product that are not specific to a particular type of device(s), including, but not limited to, the records required by 820.20. Each manufacturer is required to ensure that the QSR is prepared and approved in accordance with 820.40 as well as the Quality Review documentation used for release
11 Each manufacturer must maintain complaint files. Each manufacturer needs to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures are intended to ensure that:
1. All complaints are processed in a uniform and timely manner;
2. Oral complaints are documented upon receipt; and
3. Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting
4. Must have a good definition of a “complaint”, not just patient questions regarding technical use
Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Medical Device Reporting (MDR) is one of the post market surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of medical devices.
Device Manufacturers are required to submit certain types of reports for adverse events and product problems to the FDA in a very short time about identified problems with a medical device. If you are a manufacturer, you are considered to have become aware of an event when any of your employees becomes aware of a reportable event that is required to be reported within 30 calendar days or that is required to be reported within 5 work days because the FDA requested reports in accordance with 803.53(b)
Who Will Benefit
• Quality Assurance (QA) Professionals
• Operations Management Professionals
• Medical Device distributors
• Consumers, Patients
• Compliance Officers
• Health Information Managers
• Legal Counsel
• Data and Device Standards experts
• Audit/Inspection coordinators, internal auditors
• IT / IS managers and personnel
• Consultants and Strategists
Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.
He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training.
Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered an expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediationView all trainings by this speaker