The FDA by charter has what appears to be a role with contradictory goals when it comes to medical devices:
It creates public and political pressure from two directions. If it acts too carefully and too slowly, it will stand accused of preventing treatments from reaching patients, often in emergency conditions, by creating too many hurdles. If it acts too rapidly and carelessly, it will stand accused of failing to protect the public health.
For this reason, the FDA regulates medical devices both pre-market and post-market.
”The right balance of premarket and postmarket data collection facilitates timely patient access to important new technology without undermining patient safety. FDA believes this guidance document will improve patient access to safe and effective medical devices that are important to the public health by improving the predictability, consistency, transparency, and efficiency of the premarket review process. This guidance document is intended to support FDA’s efforts to enhance timely availability of devices subject to premarket approval.”
Source:
“Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Guidance for Industry and Food and Drug Administration Staff” https://www.fda.gov/media/88381/download
Given the plethora of Emergency Use Authorizations (EUAs) and the rapid development and emergence of new treatments, it is next to impossible to collect all relevant data prior to market release. There is a clear public need to both allow release of new devices into the market while continuing to gather real-time data on the effects and uses of these devices.
The FDA´s two new draft guidance documents are intended to clarify proper post-market surveillance and reporting as well as making these available to the public. The focus is on Class II (moderate risk) and Class III (high risk) medical devices. The first guidance is intended to provide clear rules and methods for reporting post-market information to the agency which, in turn, allows the agency to post this information to the public in the 522 Postmarket Surveillance Program Database.
The second study provides guidance on post-approval studies. As many stakeholders are involved in a study, from manufacturers, to health care facilities, providers, and patients, this guidance is intended to assist them in gathering and reporting that data and in conducting the studies.
The FDA is continuously evolving and must strive to keep up with so many pressures and issues competing for its attention. These guidance documents provide the agency´s current thinking so that the public and other stakeholders are not left to decipher regulations without clearly understanding the expectations.
Here are 5 of the top impacts of the new FDA Guidances and how these will affect companies:
Any changes to the plan must be reviewed and approved by the FDA.
Changes to an Approved Post-Approval Study Protocol must be submitted, reviewed, and approved.
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