CDRH Research Programs provide users with a wealth of information covering a variety of topics and clinical areas. The CDRH has released a new webpage providing more information on its Research Programs. The new webpage allows users to search research by special topic or by clinical area, including: Anesthesiology, General Hospital, Respiratory, Infection Control, Dentistry, Cardiovascular, Neurology and Physical Medicine, Orthopedics, … Read More
Intravascular Medical Devices: Lubricious Coating Separation
For over 20 years lubricious coatings have offered patients the opportunity to have less invasive procedures. Medical devices used during procedures in the cerebrovascular, cardiovascular, and peripheral vascular systems often have hydrophilic and/or hydrophobic lubricious coatings to reduce friction, which creates better maneuverability and less trauma to the blood vessels. Although the coating is very beneficial the FDA wants health care providers to be aware … Read More
Medical Device Export Certificates
Exporting medical devices from the United States often requires a certificate for products regulated by the FDA. An export certificate gives information from the FDA on the product’s regulatory status. The FDA has revised medical device export certificates fees for the second time since the program began in 1996. Medical device export certificate processing costs have gone up over … Read More
Procedures for Meetings of the Medical Devices Advisory Committee
The CDRH issued the Procedures for Meetings of the Medical Devices Advisory Committee draft guidance on April 1, 2015. This draft guidance explains the processes for meetings of the Medical Devices Advisory Committee panels. Panel meetings provide an opportunity for addressing scientific, clinical, or public health issues. Medical Device Advisory Committee Panels functions: Panels may give expertise for medical device premarket submissions … Read More
MDDS, Medical Image Storage Devices, & Medical Image Communications Devices Final Guidance
The Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices final guidance has been released. The FDA posted a regulation down-classifying Medical Device Data Systems (MDDS) from Class III to Class I on February 15, 2011. Class I devices are subject to general controls under the FD&C Act. A draft guidance regarding MDDS was issued on … Read More
General Wellness: Policy for Low Risk Devices
The FDA has issued a draft guidance document to provide information for low risk products that promote a healthy lifestyle. CDRH defines general wellness products as products that “are intended for only general wellness use, and present a very low risk to users’ safety.” A general wellness product must either help to maintain a general state of health, or help to reduce the risk or … Read More
Medical Device Recall vs. Enhancement
The Distinguishing Medical Device Recalls from Medical Device Enhancements guidance addresses questions and inconsistencies that arise when making changes to a marketed device. When determining whether a change to a device is classified as a recall or enhancement, you should always carefully review all appropriate regulations. The FDA defines a medical device recall as “a firm’s removal or correction of … Read More
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Draft Guidance
The Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices draft guidance has been released to communicate the FDA’s standpoint on enforcing regulatory controls in regards to digital health efforts. The FDA understands that medical device access to digital technology has the opportunity to create more efficient and improved patient care. This draft guidance discusses how … Read More
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