FDA CDRH Updates
The latest guidances, approvals, and safety alerts from FDA CDRH, curated by automated regulatory intelligence.
Clarifies FDA CDRH’s approach for premarket submissions involving robotically-assisted surgical devices, including the types of information expected to support…
Provides a draft electronic submission template approach for PMA applications, aiming to standardize how premarket approval information is organized and…
Provides FDA’s expectations for 510(k) premarket notification submissions for dental curing lights, clarifying what information and testing should be included…
Clarifies FDA’s expectations for 510(k) premarket notification submissions for dental composite resin devices, focusing on how manufacturers should justify…
Establishes FDA expectations for applying human factors and usability engineering throughout the medical device lifecycle to reduce use-related harms and…
Clarifies the 510(k) premarket notification expectations for hemodialysis blood tubing sets, outlining how manufacturers should structure device submissions to…
Clarifies FDA’s intent to exempt certain categories of otherwise unclassified medical devices from the premarket notification (510(k)) requirement, reducing…
Topic: Premarket Status: Final.
Clarifies FDA’s approach for evaluating orthopedic implants when guides are intended to be patient-matched, including expectations for how manufacturers…
Topic: Status: Draft.
Topic: Status: Final.
Clarifies FDA CDRH premarket considerations for medical devices whose indications are associated with weight loss, emphasizing how device claims should be…
Topic: Premarket Status: Final.
Topic: Postmarket Status: Final.
Topic: Status: Final.
Topic: Premarket Status: Draft.
Clarifies FDA’s approach for “General Wellness” low-risk device oversight, outlining the premarket pathway and expectations for devices that may be eligible…
Topic: Postmarket, Premarket, Real World Data / Real World Evidence (RWD/RWE) Status: Final.
Topic: Premarket, User Fees Status: Final.
Outlines FDA’s draft approach for premarket performance testing and labeling for menstrual products, which may affect how sponsors design validation studies…