Postmarket

Infographic: FDA Requirements for Medical Technology (Two Pager)

JRose — Wed, 08 Aug 2018 19:06:53 +0000

Infographic: FDA Requirements for Medical Technology

JRose — Tue, 07 Aug 2018 21:09:08 +0000

FDA Fact Sheet: Enforcement Actions

JRose — Mon, 23 Jul 2018 21:22:45 +0000

FDA can take several actions to protect public health. Enforcement actions may follow from violations uncovered by FDA during Quality System inspections, reports from competitors, and FDA monitoring of industry practices. FDA usually works with the manufacturer to achieve voluntary correction of violations.

FDA Fact Sheet: Recalls

JRose — Fri, 25 May 2018 13:32:15 +0000

When initiated, a recall serves to protect the public health from products that present a risk of injury, gross deception or are otherwise defective. Depending on the nature of the violation and the risk to public health, a recall can include actions ranging from a simple labeling change, an in-field correction or a full or partial removal of the product from the market. Medical device recalls are typically conducted voluntarily, under 21 CFR 7, by the manufacturer or distributor.

FDA Fact Sheet: Medical Device Tracking

JRose — Fri, 25 May 2018 13:28:58 +0000

FDA has the authority to order manufacturers of certain medical devices to establish and maintain systems to track their devices (21 CFR 821). This is to ensure manufacturers can expeditiously remove a device from the market if necessary and notify patients and providers of any significant issues with a device.

FDA Fact Sheet: Unique Device Identification (UDI)

JRose — Fri, 25 May 2018 13:27:39 +0000

FDA Fact Sheet: Quality Systems

JRose — Fri, 18 May 2018 18:23:48 +0000

The Quality System (QS) regulation (21 CFR Part 820) is designed to ensure that manufacturers have procedures and processes in place to produce safe and effective devices. QS requirements cover topics including: quality management and organization, device design, equipment, purchasing and handling of components, production and process controls, packaging and labeling controls, distribution, installation, complaint handling, servicing, and recordkeeping.

FDA Fact Sheet: Postmarket Surveillance

JRose — Fri, 18 May 2018 18:22:20 +0000

FDA has a range of requirements that can be imposed on manufacturers regarding postmarket surveillance activities.

FDA Fact Sheet: Postmarket Inspections

JRose — Fri, 18 May 2018 18:20:28 +0000

FDA inspects medical device manufacturers to evaluate their compliance with the Quality System (QS) regulation and other pertinent requirements. Inspections assess the firm’s systems, processes and procedures to ensure that manufacturers can produce devices in a consistent manner that meets all specifications.

FDA Fact Sheet: Medical Device Reporting

JRose — Fri, 18 May 2018 18:13:17 +0000

Post-marketing surveillance of adverse events involving medical devices is the responsibility of both the device manufacturer and the health care facility utilizing the device. Medical Device Reporting (MDR) regulations require manufacturers to report to FDA device-related incidents, deaths, serious injuries, and device malfunctions which are likely to cause or contribute to death or serious injury if they were to occur. Health care facilities are required to report patient deaths suspected of being associated with devices to both the manufacturer and FDA.

FDA Fact Sheet: Direct-to-Consumer Advertising

JRose — Fri, 18 May 2018 18:12:05 +0000

Medical device manufacturers risk violating the Federal Food, Drug, and Cosmetic Act (FDCA) if their advertising in support of a product are not consistent with product’s FDA cleared or approved use. The regulation of promotional materials and activities also fall within the jurisdiction of the Federal Trade Commission. Industry takes its responsibilities seriously to ensure compliance, foster responsible and informative DTC communications, and encourage discussion with health care professionals to learn about healthcare treatment options.

FDA Fact Sheet: Condition of Approval Studies

JRose — Fri, 18 May 2018 17:19:09 +0000

Through review of a Premarket Approval Application (PMA), FDA evaluates the safety and effectiveness of Class III medical devices. To help assure the continued safety and effectiveness of an approved device, in some cases FDA may require a post-approval study, also referred to as condition of approval study. A post-approval study may be a clinical or non-clinical study required at the time of approval and is intended to gather specific information to address questions about the postmarket performance of or experience with an approved medical device.