FDA new user fees for fiscal year 2018 will leave a dent in your pockets!! “Be ready for a STICKER SHOCK” The FDA announced the FY18 user fees in the August 28, 2017 Federal Register Notice titled Medical Device User Fee Rates for Fiscal Year 2018. The FDA notice establishes the fee rates for FY
Qualification of Medical Device Development Tools (MDDT) – Guidance for Industry, Tool Developers, and Food and Drug Administration Staff FDA released the final guidance on MDDT which was launched as a pilot plan in 2013 to provide guidance on a voluntary program for qualification of medical device development tools (MDDT) for use in evaluating devices
Voluntary Cosmetic Registration Program Report for July 2017. FDA’s Voluntary Cosmetic Registration Program (VCRP) is a reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States. The VCRP applies only to cosmetic products being sold to consumers in the United States. It does not
Congress passes FDA Reauthorization Act (FDARA) of 2017 A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes was passed by the Congress on August 3, 2017. The federal budget process occurs
The FDA did something good for digital health — even skeptics agree FDA Announces New Steps to Empower Consumers and Advance Digital Healthcare!! FDA announced a pilot program that might result in a “pre-certification” for digital health startups. That would provide some much-needed clarity for digital health startups, and a potential fast-track to get a
Field Alert Reports – FDA Introduces the Automated Form 3331a The Federal Food, Drug and Cosmetic Act, section 505(k) requires New Drug Application (NDA) holders to provide a Field Alert Report, on distributed drug product, to the Agency with any information concerning any incident that causes the drug product or its labeling to be mistaken
FDA Intends to Extend Compliance Dates for Agricultural Water Standards!! The FDA Food Safety Modernization Act (FSMA) Produce Safety rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. Agricultural water can be a major conduit of pathogens that can
FDA intends to extend the compliance dates for the unique device identification system (UDI system) requirements for Class I and unclassified device! On September 24, 2013, FDA published a final rule establishing a unique device identification system, including unique device identifier (UDI) labeling and data submission requirements (78 FR 58786) (the UDI Rule). Generally, under
Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs (FSVP) Regulation.
The FDA new guidance provides information on how the importers will comply with FDA’s requirement to identify themselves as the importer of a food at entry into the United States under the Foreign Supplier Verification Programs (FSVP) regulation, including the requirement to provide a unique facility identifier (UFI) recognized as acceptable by FDA. On March
European Commission (EU) approves Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to ensure safety of Medical Device.
People rely on medical device ranging from simple contact lenses to sophisticated pacemakers to improve the health and quality of life and so expect them to be safe and incorporate the latest progress in science and innovation. To reflect the substantial technological and scientific progress in this sector over the last 20 years, the European