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.

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.

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. #FDA #MedicalDevice.

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

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

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.

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.

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

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

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

Today, the #FDA provided recommendations regarding best practices for utilizing animal studies for the evaluation of organ preservation devices. #MedicalDevice

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

Today, @US_FDA alerted providers and patients to check for premature battery depletion in certain Medtronic pacemakers and CRT-Ps #safety #MedicalDevice

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: #MedicalDevice

Learn more about @US_FDA’s final guidance issued today on the Q-Submission Program for Medical Device Submissions:

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.

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

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.

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.

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.