News & Events

Weekly Media Tip Sheet

FDA News & Notes – Week of Aug. 8, 2016

Science, public health, and regulatory highlights from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of Aug. 1, 2016. Times listed are local time.

FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.

Meetings, Workshops and Congressional Testimony:
 
Wednesday, 8/10 – The Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee will meet to discuss, make recommendations and vote on information regarding a de novo request for the Seeker Newborn Screening System (Seeker System), by Baebies, Inc. The Seeker System consists of the Seeker Analyzer, the Seeker 4-Plex Assay Kit, the Seeker Cartridges, the Spot Logic software, and quality control materials; it uses digital microfluidic technology to measure multiple lysosomal enzymatic activities quantitatively from newborn dried blood spot specimen. The meeting will take place beginning at 8 a.m. at the Hilton Hotel, Gaithersburg, Md.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov   
 
In Case You Missed It:
     
Friday, 8/5 – News Release: FDA issues draft updated recommendations on submitting a new 510(k) for device modifications. The FDA issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market, including a separate guidance applicable to software devices.
Press Office Contact: Deborah Kotz, 301-796-5349, deborah.kotz@fda.hhs.gov
 
Thursday, 8/4 – News Release: Kratom seized in California by US Marshals Service. The FDA announced that the U.S. Marshals Service seized more than 100 cases of products labeled as containing kratom. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy, and are worth approximately $150,000.
Press Office Contact: Lyndsay Meyer, 240-402-5345, lyndsay.meyer@fda.hhs.gov  
 
Monday, 8/1FDA Voice Blog: Piloting an Improved Intercenter Consult Process. Combination products—those that combine drugs, devices, and/or biological products—present both policy and review challenges in large part because they include constituent parts that fall into more than one regulatory category (e.g., drug and device; drug and biologic) covered by more than one FDA product center. As such, close intercenter collaboration and communication are important to facilitate timely, appropriately-tailored and well-informed submission review.
Press Office Contact: FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov 
 
   

FDA Office of Media Affairs Contact Information:

FDA News & Notes Inquiries: Fallon Smith, 301-796-8632, fallon.smith@fda.hhs.gov
General Inquiries: Call or e-mail FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov
List of FDA Press Officers and beats

More Resources:

Read our Blog: FDA Voice
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Consumer Health Information

Page Last Updated: 08/16/2016
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