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FDA

FDA: Abbreviated, Special and Traditional 510(k) Clearance Applications

FDA: Abbreviated, Special and Traditional 510(k) Clearance Applications

The FDA has just issued four final guidance documents related to the 510(k) clearance applications for medical devices.  The Guidance documents can be found here, and they describe the FDA’s current thinking on special 510(k) clearance programs such as the Abbreviated application and the newly established “Special 510(k)” program. 

Out of the Box:  The FDA Wants to Understand How Prescribers Consider Serious Drug Safety Information.

Out of the Box: The FDA Wants to Understand How Prescribers Consider Serious Drug Safety Information.

We see the advertisements on the television, the music plays and people start barbequing, playing frisbee with their dogs, or walking through their neighborhood greeting neighbors with a smile.  A voiceover describes some medical condition, and then, they tell you that there’s a drug that may help.  After about thirty seconds of hearing about how the drug may help treat a specific condition, the voice starts to tell you all the things that may go wrong. 

Breakthrough Devices: CMS Removes Hurdles and Increases Payments for New Technology Add-On Payments Under the IPPS Final Rule

Breakthrough Devices: CMS Removes Hurdles and Increases Payments for New Technology Add-On Payments Under the IPPS Final Rule

Hospitals and medical device manufacturers will both benefit from the Centers for Medicare and Medicaid Services’ (CMS) finalization of the 2020 Inpatient Prospective Payment System (IPPS) Final Rule (“Final Rule”) scheduled to be published on August 16, 2019.  In an effort to increase Medicare beneficiaries’ access to innovative medical technologies, CMS has finalized certain changes to the “new technology add-on payment” “(NTAP) application and payment processes under the Final Rule. This change is likely to encourage hospital adoption of new technologies, which is intended to spur innovation and additional investment in these technologies.

UPDATE: VDACS Food Safety Program Releases CBD Manufacturing Requirements for Virginia Industrial Hemp Processors

UPDATE: VDACS Food Safety Program Releases CBD Manufacturing Requirements for Virginia Industrial Hemp Processors

Following its July 15th letter to Virginia Industrial Hemp Processors (“Processors”) notifying them of Governor Ralph Northam’s recent directive regarding the manufacture of CBD in Virginia, the VDACS Food Safety Program (the “FSP”) sent a letter to Processors on Friday, July 26th setting forth guidelines for Processors to follow when manufacturing cannabidiol (“CBD”) products intended for human consumption (the “Food Safety Letter”).

VDACS Okays Manufacture of CBD Products Intended for Human Consumption

VDACS Okays Manufacture of CBD Products Intended for Human Consumption

The Virginia Department of Agriculture and Consumer Services (“VDACS”) Commissioner Jewel Bronaugh sent a letter (the “July Letter”) to all Virginia-registered Industrial Hemp Processors (“Processors”) on July 15, 2019 notifying the Processors that Governor Northam’s office has directed VDACS to “treat hemp-derived extracts intended for human consumption as approved food additives and to place qualifying Registered Industrial Hemp Processors under food safety inspection so that inspected and approved processors may manufacture a hemp-derived extract for human consumption.”

CLIENT ALERT: FDA Pilot Program Seeking Software Developers

CLIENT ALERT: FDA Pilot Program Seeking Software Developers

The U.S. Food and Drug Administration is currently accepting requests from medical software developers to participate in a precertification pilot program that is scheduled to begin September 1, 2017.  The program is aimed at developing precertification criteria for software companies that would allow approved companies to engage in a streamlined premarket review process for certain digital health products.  The FDA will accept up to nine participants for the pilot program, which the Agency says will include both large, established software developers and small startup companies.