Process Validation and Additive Manufacturing (AM) -Validate your 3D Printing for Compliance and Business Success Medical device makers are enthusiastic about 3D printing. They are not alone. As 3D printing (or additive manufacturing, AM for short) goes from niche to commonplace, players are determined for sales in this lucrative market. This manufacturing sector is expected
Deciding When to Submit a 510(k) for a Change to an Existing Device?? Earlier this week, the FDA issued a new guidance regarding deciding when to submit a 510(k) for a change to an existing device which superseded the original guidance document released in 1997. The new guidance has taken the original content and
FDA Seeks Comments on Breakthrough Devices Guidance On December 13, 2016, the Breakthrough Devices program was added to the Food, Drug, and Cosmetic Act. The program helps patients have more timely access devices and breakthrough technologies that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared
FDA Qualifies First Tool under Medical Device Development Tools (MDDT) Program The FDA recently qualified the first tool under the medical device development tools (MDDT) program. This is a voluntary process that can reduce regulatory burden for medical device developers and FDA reviewers by qualifying tools that can aid in the development and evaluation of
Changes to CDRH Export Certification and Tracking System (CECATS) As of September 25, 2017, the FDA has updated the CDRH Export Certification and Tracking System (CECATS). CECATS is the web-based system for requesting export documents and certificates for international trade which has been implemented to process applications and requests more efficiently than the mail-in
NEW FDA REQUIREMENT!!DRUG PRODUCT LISTING ANNUAL RENEWAL!! As a part of the eDRL Final Rule and under Sections 510(j)(2)(B) & 510(j)(2)(D) of the Food Drug And Cosmetic Act, drug product labelers must certify annually all drug product listings that have not already been updated during the calendar year. If there is no change in drug
FDA released the final guidance document “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” As electronic medical devices are increasingly connected to each other and to other technology, the ability of these connected systems to safely and effectively exchange and use the information that has been exchanged becomes increasingly important. Advancing the ability
FDA Releases Compliance Guide for Small Businesses under FSMA Produce Safety Rule 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. The definition of “farm” and related terms were revised
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
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