FDA Medical Devices
@FDADevices

Official FDA - device recalls, safety, authorizations, radiation-emitting products. Contact us DICE@fda.hhs.gov or 800-638-2041 fda.gov/privacy

 Silver Spring, Maryland, USA
fda.gov/medical-devices/
Joined May 2010
2,114 Photos and videos
Join us for FDA Grand Rounds on Oct 22. Learn about CDRH’s Real-World Evidence (RWE) Program & how it applies to digital health technology. Hear from CDRH experts & gain practical insight into how the RWE Program could support evidence generation. This event will be offered in a hybrid format, with options to attend in person at the FDA White Oak Campus or virtually via webcast. FDA.gov/GrandRounds
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FDA Medical Devices retweeted
U.S. FDA
@FDA
Oct 1
Today, we approved the first heart valve device designed to grow with children. The Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease can be expanded after surgery to keep pace with growth. The adjustable valve may mean fewer repeat surgeries for children as they get older. fda.gov/news-events/press-an… Congenital heart defects are among the most common types of birth defects in the United States, affecting about 1 in every 100 births. The valve was approved through the premarket approval pathway, the FDA's most rigorous review process for medical devices.
A child stands with a hand on their chest, while someone is holding a model of a heart. Text reads, "FDA approves first heart valve designed to grow with children." The FDA logo is visible.

ALT A child stands with a hand on their chest, while someone is holding a model of a heart. Text reads, "FDA approves first heart valve designed to grow with children." The FDA logo is visible.

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Join the FDA for a public workshop: Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities — Dec. 2–3, 2026. Topics span surgical & non-surgical robotic medical devices, both inside and outside the OR. Workshop materials will be posted on the registration page when available. Register to attend: fda.gov/medical-devices/prod…
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The FDA has issued a draft guidance: Robotically-Assisted Surgical Devices — Premarket Submissions. The guidance, when finalized, will help manufacturers understand what safety & effectiveness information to include in premarket submissions for these devices. Submit comments by Nov. 24, 2026: fda.gov/regulatory-informati…
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FDA Medical Devices retweeted
FDA Medical Devices
@FDADevices
Sep 21
The FDA posted materials for the upcoming Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee (the Committee) meeting on September 23, 2026. Access the meeting materials and webcast link. The Committee will discuss GRAIL Inc.’s Galleri® test premarket approval application. The Galleri® test is a prescription-only qualitative next-generation sequencing-based in vitro diagnostic blood test intended for screening for the early detection of multiple types of cancer in adults aged 50 years or older: fda.gov/advisory-committees/…
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During public health emergencies, the FDA’s Center for Devices and Radiological Health supports the development and evaluation of critical medical countermeasures to address emerging threats and meet urgent public health needs. Emergencies can happen at any time. Taking a few steps now can help you stay safe and keep  your medical devices working when you need them most. fda.gov/emergency-preparedne… #NationalPreparednessMonth
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Last Call: If you would like to be a participant for the READI-Home Innovation Challenge your submission is needed by September 30th! Don’t miss your chance to make an impact. fda.gov/medical-devices/home…
"FDA graphic with teal background and white outline illustration of a large crowd. Bold white text reads: Last Call! Dark blue text box with white text reads: Send in your submission for the READI-Home Innovation Challenge by September 30. FDA logo in upper right corner."

ALT "FDA graphic with teal background and white outline illustration of a large crowd. Bold white text reads: Last Call! Dark blue text box with white text reads: Send in your submission for the READI-Home Innovation Challenge by September 30. FDA logo in upper right corner."

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Mark your calendars: The FDA will hold a public meeting on Nov. 19 of the Microbiology Devices Panel of the Medical Devices Advisory Committee. The Committee will meet to discuss and provide recommendations to the Agency on the use of pathogen-agnostic sequencing for emergency preparedness and response efforts. A public docket is open. Learn more and submit comments: fda.gov/advisory-committees/…
A square, blue-background meeting announcement graphic from the FDA. In the upper left is a white icon of a calendar with a clock. In the upper right is the FDA logo in a white box. A dark navy banner across the middle reads "MEETING ANNOUNCEMENT" in large bold white text. Below it, bold white text reads: "Microbiology Devices Panel of the Medical Devices Advisory Committee." A smaller navy box contains the date and time: "November 19, 2026, 9:00 AM – 4:00 PM ET." Below that, bold white text reads: "FDA White Oak Campus and Virtual."

ALT A square, blue-background meeting announcement graphic from the FDA. In the upper left is a white icon of a calendar with a clock. In the upper right is the FDA logo in a white box. A dark navy banner across the middle reads "MEETING ANNOUNCEMENT" in large bold white text. Below it, bold white text reads: "Microbiology Devices Panel of the Medical Devices Advisory Committee." A smaller navy box contains the date and time: "November 19, 2026, 9:00 AM – 4:00 PM ET." Below that, bold white text reads: "FDA White Oak Campus and Virtual."
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The FDA is announcing the new CDRH Rare Disease Impact Initiative to help address the unique challenges of rare disease device development and facilitate the advancement of medical devices for people with rare diseases. fda.gov/about-fda/center-dev…
A square promotional graphic on a bright blue background. The FDA logo — white letters "FDA" on a white square background with a blue border — appears in the upper right corner. On the left side, large bold white text reads: "FDA is launching the" followed by "Rare Disease Impact Initiative" highlighted in a dark purple banner, then "for medical devices." Three large abstract organic shapes are layered in the lower right: a bright pink flower-like shape, a green amoeba-like shape on the lower left, and a dark purple irregular shape in the center foreground.

ALT A square promotional graphic on a bright blue background. The FDA logo — white letters "FDA" on a white square background with a blue border — appears in the upper right corner. On the left side, large bold white text reads: "FDA is launching the" followed by "Rare Disease Impact Initiative" highlighted in a dark purple banner, then "for medical devices." Three large abstract organic shapes are layered in the lower right: a bright pink flower-like shape, a green amoeba-like shape on the lower left, and a dark purple irregular shape in the center foreground.

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Thinking about clear dental aligners? Learn how FDA-authorized clear aligners work, their benefits and limitations, why professional supervision matters, and what patients should know before beginning treatment. fda.gov/medical-devices/dent…
"A person is holding two transparent dental aligners. The image includes the FDA logo and text that says, “Thinking about clear dental aligners? Know the benefits. Understand the risks.”

ALT "A person is holding two transparent dental aligners. The image includes the FDA logo and text that says, “Thinking about clear dental aligners? Know the benefits. Understand the risks.”

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What are PFAS and how do they affect you? The FDA has issued FAQs for consumers on PFAS (per-and polyfluroralkyl substances) for medical devices. Get the latest information here. fda.gov/medical-devices/prod…
Blue graphic with the FDA logo. Text reads: "FDA issuing new FAQs on PFAS in medical devices." Icons of people and speech bubbles are present.

ALT Blue graphic with the FDA logo. Text reads: "FDA issuing new FAQs on PFAS in medical devices." Icons of people and speech bubbles are present.

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SAFETY NOTIFICATION: We have issued a Safety Notification for Mammography Center of Monterey (CA), which has not complied with an FDA order to notify patients about possible mammogram quality concerns. Patients who received services on or after Dec. 22, 2023, should talk to their healthcare provider. Learn more: fda.gov/radiation-emitting-p…
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NEWS: The FDA has authorized the first wearable sensor that continuously measures ketone levels, along with blood sugar (glucose). fda.gov/news-events/press-an…
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FDA Medical Devices retweeted
U.S. FDA
@FDA
Aug 21
Getting your blood drawn just got a whole lot more high-tech! The FDA has authorized the Vitestro Aletta — the first robotic device that can perform a complete blood draw without operator intervention. Learn more: fda.gov/news-events/press-an… #FDA #MedicalDevices
The image is an infographic from the FDA announcing the authorization of a first-of-its-kind robotic blood draw device. It includes an illustration of the robotic device, three test tubes, and a small droplet of blood. The FDA logo is visible in the top right corner. The background is dark blue with a green banner stating "Medical Device Authorization.

ALT The image is an infographic from the FDA announcing the authorization of a first-of-its-kind robotic blood draw device. It includes an illustration of the robotic device, three test tubes, and a small droplet of blood. The FDA logo is visible in the top right corner. The background is dark blue with a green banner stating "Medical Device Authorization.

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Update: The FDA selected three more participants for the TEMPO pilot! TEMPO aims to promote access to certain digital health devices intended to improve health outcomes for managing certain chronic diseases while safeguarding patient safety. fda.gov/medical-devices/digi…
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The FDA is announcing a meeting on Sept. 23 of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee (the Committee) to discuss GRAIL Inc.’s Galleri® test premarket approval application.
Meeting announcement graphic for the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, scheduled for September 23, 2026, 9:00 AM – 6:00 PM ET, at the FDA White Oak Campus and virtually. FDA logo appears in the upper right corner.

ALT Meeting announcement graphic for the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, scheduled for September 23, 2026, 9:00 AM – 6:00 PM ET, at the FDA White Oak Campus and virtually. FDA logo appears in the upper right corner.

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The Galleri® test is a prescription-only blood test intended for screening for the early detection of multiple types of cancer in adults aged 50 years or older. The FDA is establishing a docket for public comment. For more details and to learn how to submit written comments:
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fda.gov/advisory-committees/…

Molecular and Clinical Genetics Panel of the Medical Devices Advisory

FDA announcement of 2026 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting

fda.gov
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One more day! Tomorrow we make the switch to @FDADevices on X. Current followers don't need to do a thing to your… devices. You'll continue following us without any changes.
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