Article

March 5 deadline for comments about FDA 510(k) process

The public has until March 5 to submit comments related to presentations made at a Feb. 18 public hearing at which FDA officials discussed challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States.

Washington, DC

-The public has until March 5 to submit comments related to presentations made at a Feb. 18 public hearing at which FDA officials discussed challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States.

Presentations from the meeting are posted at

www.regulations.gov

; search for FDA-2010-N-0054. Electronic comments may be submitted to the docket. Written comments may be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

The FDA receives more than 3,000 510(k) submissions each year. Last year, the agency asked the Institute of Medicine (IOM) to conduct a comprehensive study of the process. The IOM study is expected to conclude in about a year.

In the meantime, the Feb. 18 meeting is expected to support the efforts of an internal working group convened by FDA to evaluate and improve the quality and consistency of the agency’s decision-making in the 510(k) process as well as its administration of the program. An agency task force is scheduled to announce recommended policy changes in June.

Newsletter

Don’t miss out—get Ophthalmology Times updates on the latest clinical advancements and expert interviews, straight to your inbox.

Related Videos
Lisa Nijm, MD, says preoperative osmolarity testing can manage patient expectations and improve surgical results at the 2025 ASCRS annual meeting
At the 2025 ASCRS Annual Meeting, Weijie Violet Lin, MD, ABO, shares highlights from a 5-year review of cross-linking complications
Maanasa Indaram, MD, is the medical director of the pediatric ophthalmology and adult strabismus division at University of California San Francisco, and spoke about corneal crosslinking (CXL) at the 2025 ASCRS annual meeting
(Image credit: Ophthalmology Times) ASCRS 2025: Taylor Strange, DO, assesses early visual outcomes with femto-created arcuate incisions in premium IOL cases
(Image credit: Ophthalmology Times) ASCRS 2025: Neda Shamie, MD, shares her early clinical experience with the Unity VCS system
Patricia Buehler, MD, MPH, founder and CEO of Osheru, talks about the Ziplyft device for noninvasive blepharoplasty at the 2025 American Society of Cataract and Refractive Surgeons (ASCRS) annual meeting
(Image credit: Ophthalmology Times) ASCRS 2025: Bonnie An Henderson, MD, on leveraging artificial intelligence in cataract refractive surgery
(Image credit: Ophthalmology Times) ASCRS 2025: Gregory Moloney, FRANZO, FRCSC, on rotational stability
Sheng Lim, MD, FRCOphth, discusses the CONCEPT study, which compared standalone cataract surgery to cataract surgery with ECP, at the 2025 ASCRS Annual Meeting.
(Image credit: Ophthalmology Times) ASCRS 2025: Steven J. Dell, MD, reports 24-month outcomes for shape-changing IOL
© 2025 MJH Life Sciences

All rights reserved.