FDA’s Updated Approach to the 510(k) Premarket Notification Process for Medical Devices
Enhancing Safety and Efficiency
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Category: Medical Devices
Streamlining Pathways to FDA Medical Device Market Clearance/Approval
FDA Updates Draft Guidance for Medical Device Submissions: The Q-Submission Program
FDA Medical Device Establishment Registration
FDA Proposes Modifications to Medical Device User Fee Small Business Qualification and Certification
Heads Up Medical Device (and Cosmetic Device) Manufacturers and Importers!
FDA Makes Changes to Device GMPs to Align More Closely with International Consensus Standards.
FDA Revisiting Classification of Wound Dressings and Liquid Wound Washes
Last week, FDA proposed two new rules to classify certain unclassified, wound dressings and liquid wound washes containing antimicrobials or other chemicals into three separate classification regulations: Solid wound dressings: this covers products intended to cover and protect a wound against external contamination, to absorb exudate and to maintain appropriate moisture balance within the wound […]
It’s that Special Time of Year Again! FDA Device Registration Renewal
FDA’s 2023 device registration renewal period!
Moving the Needle and Modernizing the 510(k) Process
FDA recently announced its latest efforts to strengthen and modernize the 510(k) process and to advance the safety and effectiveness of medical devices. As part of its ongoing commitment to optimize the clarity, predictability and consistency of the 510(k) Program, the Agency announced the release of three new draft guidance documents in alignment with the […]
CBP Liquidated Damages, Penalties, & Fines…oh my!
How to Avoid and Mitigate U.S. Customs Liquidated Damages and Penalties Did you know that U.S. Customs can assess penalties up to 3x the value of goods if you fail to export or destroy FDA refused merchandise timely? On top of FDA compliance concerns associated with FDA detained and ultimately refused goods, numerous other costs […]
What you Need to Know about FDA Device Regulation
Marketing Sunglasses, Bandages, Hospital Equipment, Pregnancy Test Kits, Cosmetic Devices, Personal Lubricants and More The U.S. leads the world in medical innovation and is the largest consumer of medical devices in the world. We use medical devices daily, whether it is throwing on a pair of sunglasses, hitting the ski slopes with a pair of […]
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I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.