FDA/CDRH Industry

This is the archived account of @FDACDRHIndustry. Follow us at @FDADeviceInfo for the latest on medical device & radiation-emitting products info from the FDA.

[FDA/CDRH Industry @FDAcdrhIndustry]

To reduce duplication and provide a single source of information for our Twitter audience, today we are archiving the @FDACDRHIndustry Twitter handle. Follow us at @FDADeviceInfo to get FDA medical device news and updates.

[FDA/CDRH Industry @FDAcdrhIndustry]

Deadlines:
•5/10: Request to make a formal oral presentation at the panel meeting
•5/20: Submit written comments to the panel
•5/30: Attend the panel meeting in Gaithersburg, MD
•6/24: Submit written comments on the proposed order to reclassify to docket FDA-2019-N-1250

[FDA/CDRH Industry @FDAcdrhIndustry]

On May 30, 2019 the @US_FDA will host the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee from 9 a.m. to 4 p.m. EST in Gaithersburg, MD. **Note the time changed from 10 am as stated in the FR notice to 9 am** #MedicalDevice

[FDA/CDRH Industry @FDAcdrhIndustry]

We are also seeking public input on the proposed reclassification of surgical staplers for internal use from Class I to Class II. We invite any interested parties to participate in the public panel meeting and to submit comments. https://t.co/CUk9gpYcUO #FDA #MedicalDevice

[FDA/CDRH Industry @FDAcdrhIndustry]

Classification & Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57); Final Guidance clarifies the FDA’s performance standard requirements & the International Electrotechnical Commission lamp standard for Laser Illuminated Projectors https://t.co/cnNHL1u8Sq

[FDA/CDRH Industry @FDAcdrhIndustry]

Today @US_FDA issued two final guidances on laser products that better align current FDA regulatory requirements for laser product safety with international consensus standards.

[FDA/CDRH Industry @FDAcdrhIndustry]

Laser Products -- Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56); Final Guidance describes the @US_FDA’s approach to compliance with the #FDA’s performance standards for laser products. https://t.co/ubajihMQXV

[FDA/CDRH Industry @FDAcdrhIndustry]

Policy Clarification for Certain Fluoroscopic Equipment Requirements Final Guidance intends to clarify #FDA’s interpretation of certain aspects of the performance standard requirements in 21 CFR 1020.30 and 1020.32 for fluoroscopic equipment https://t.co/kwkzXEjMlM

[FDA/CDRH Industry @FDAcdrhIndustry]

Today @US_FDA issued two final guidances that better align current FDA regulatory requirements for x-ray imaging with international consensus standards.

[FDA/CDRH Industry @FDAcdrhIndustry]

Medical X-Ray Imaging Devices Conformance with IEC Standards Final Guidance describes #FDA’s policy regarding the regulation of medical x-ray imaging equipment subject to the FD&C Act & FDA’s regulations that apply to medical devices & electronic products https://t.co/kCYLSj7YlK

[FDA/CDRH Industry @FDAcdrhIndustry]

Today, the #FDA provided recommendations regarding best practices for utilizing animal studies for the evaluation of organ preservation devices. https://t.co/HhuHYjdVS4 #MedicalDevice

[FDA/CDRH Industry @FDAcdrhIndustry]

The @US_FDA recognizes that best practices for conducting animal studies to evaluate organ preservation devices are evolving with the rapid advancements in technology.

[FDA/CDRH Industry @FDAcdrhIndustry]

Today, @US_FDA alerted providers and patients to check for premature battery depletion in certain Medtronic pacemakers and CRT-Ps https://t.co/6R7eVIW5hh #safety #MedicalDevice

[FDA/CDRH Industry @FDAcdrhIndustry]

SAVE THE DATE: On June 11, 2019 from 3:00 – 4:30 PM, Eastern #FDA will hold a webinar to provide an additional opportunity to learn more about the guidance and have the opportunity to interact with subject matter experts on the topic: https://t.co/VfJbYIWNt6 #MedicalDevice

[FDA/CDRH Industry @FDAcdrhIndustry]

The #FDA’s Q-Submission Program for Medical Device Submissions provides submitters an opportunity to have early collaboration and discussions with CDRH about potential or planned medical device submissions. #MedicalDevice

[FDA/CDRH Industry @FDAcdrhIndustry]

Learn more about @US_FDA’s final guidance issued today on the Q-Submission Program for Medical Device Submissions: https://t.co/gdylLKDpEg

[FDA/CDRH Industry @FDAcdrhIndustry]

#ICYMI On April 25th, @US_FDA finalized the guidance for Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices. Find out more: https://t.co/raapkKxG75 #FDA #MedicalDevice

[FDA/CDRH Industry @FDAcdrhIndustry]

Ultrahigh molecular weight polyethylene is a plastic material commonly used in orthopedic devices. Manufacturers should include test data in premarket submissions to demonstrate the material is safe and appropriate for use in their device. #FDA #MedicalDevice

[FDA/CDRH Industry @FDAcdrhIndustry]

We are committed to making a difference for women’s health & will continue working towards ensuring we understand the benefits and risks of these devices, & that women have the most complete information available to make informed breast implant decisions. https://t.co/sluUdr5FtM

[FDA/CDRH Industry @FDAcdrhIndustry]

Today, the @US_FDA announced several new steps we have taken and are considering, aimed at helping to ensure that women have access to the information they need about breast implants. #MedicalDevice