More than 95% of medical devices on the market were not required to be proven safe or effective. Less than 5% are required to be studied in clinical trials. Our goal is to improve the safety and effectiveness of all medical devices sold in the U.S. and educate healthcare professionals and patients about known and unknown benefits and risks of each device.

Comments on Transfer of Premarket Notification Clearance

We support the draft guidance “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers” with one suggested revision to Section V to help in clarifying who currently holds a 510(k) device. Overall, this guidance will help to ensure that the public information in the FDA’s 510(k) databases are accurate and up-to-date, including the most current owner of a 510(k) device.

Comments on Reclassifying External Pacemaker Pulse Generator Devices and Pacing System Analyzers

We strongly oppose the down-classification of External Pacemaker Pulse Generator (EPPG) devices and Pacing System Analyzers (PSAs) from Class III to Class II. EPPGs are clearly life-sustaining devices and they should remain in Class III and be reviewed by the more rigorous Premarket Approval (PMA) process, which will better ensure that the devices are safe and effective.

Comments on Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications

We oppose the draft guidance as written and strongly urge the FDA to rewrite it.  The current draft guidance relies on vague wording and subjective judgments, not science or technological assessments.  When it is more specific, it promotes the use of surrogate endpoints and the risk tolerance of a small number of patients whose views come to the FDA’s attention.

Comments on De Novo Classification Process

We have serious reservations about the use of the de novo classification process for implants, life-sustaining, and life-saving devices. We believe that all such high-risk devices should be Class III devices reviewed through the more rigorous PMA process. That is why we urge CDRH to revise the draft guidance to explicitly state when the de novo process may be used and when it cannot be used.

Comments on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements

The draft guidance states that the devices identified in the guidance “are sufficiently well understood and do not present risks that require premarket notification (510(k)) review to assure their safety and effectiveness.” We strongly disagree.  Some of the devices do “present risks” and should require the regulatory scrutiny provided by 510(k) premarket notification reviews.

Comments on the Proposed Rule, “Medical Device Classification Procedures”

We appreciate the opportunity to comment on the proposed rule, “Medical Device Classification Procedures.” The Food and Drug Administration (FDA) is “proposing changes to the definition of class III to provide greater clarity regarding which devices fall within this class, and to improve transparency and predictability in device classification and reclassification decisions.” We commend the FDA for seeking clarity but we have grave concerns about the ways that the proposed rule weakens current definitions of class III devices.

Comments on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices

We are writing to express our opposition to the draft guidance Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices. With this draft guidance, the FDA is notifying manufacturers and others that it “does not intend to enforce compliance with regulatory controls that apply to” medical device data systems (MDDS), medical image storage devices, and medical image communications devices.  The FDA has stated it is using its enforcement discretion on these devices because of “the low risk they pose to patients and the importance they play in advancing digital health.” We strongly disagree.

Comments on the up-classification of flu detection tests

We strongly support the up-classification of influenza detection devices. We support moving the devices from class I to class II with special controls and into a new device classification regulation (from 21 CFR 866.3330 to 21 CFR 866.3328). We agree with the FDA that “the accuracy of these devices has serious public health implications,” since influenza can cause serious illness and death.