Category: Medical Devices
An Endurance Test of Paperwork and Patience
Welcome to the FDA import detention merry-go-round, where we say, hold onto your paperwork! The FDA import detention process can be a daunting (and let’s be honest, derailing!) experience for businesses involved in importing goods, especially those in the realm of foods, cosmetics, dietary supplements, drugs or medical devices. However, with proper knowledge and strategic […]
Enhancing Safety and Efficiency
In a continuous effort to strengthen patient safety and streamline regulatory processes, FDA recently introduced significant updates to the 510(k) premarket notification process for medical devices which we previously reported on here . These revisions mark a pivotal shift in the regulatory landscape, aiming to enhance the efficiency of device clearance while maintaining stringent standards […]
FDA Updates Draft Guidance for Medical Device Submissions: The Q-Submission Program
In the intricate landscape of medical device development and approval, navigating regulatory pathways can be daunting. Among the pivotal steps in this journey lies the FDA Pre-Submission process. This process serves as a crucial bridge between medical device developers and regulatory authority, facilitating effective communication, feedback, and ultimately, smoother pathways towards product clearance or approval. […]
FDA Proposes Modifications to Medical Device User Fee Small Business Qualification and Certification
Last week, FDA issued draft guidance regarding updates for its Medical Device User Fee Small Business Qualification and Certification program, potentially opening a (small) window for FDA waiver of the medical device establishment registration fee for device establishments that are small businesses and that qualify for financial hardship. U.S. FDA medical device establishment registration and […]
FDA Makes Changes to Device GMPs to Align More Closely with International Consensus Standards.
On January 31, 2024, FDA issued a final rule, which will amend medical device current good manufacturing practice (cGMP) requirements of the Quality System (QS) Regulation under 21 CFR Part 820, to more closely align with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the […]
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 […]
FDA’s 2023 device registration renewal period!
With the smell of pumpkin spice lattes in the air and the taste of warm apple cider doughnuts, comes another special time of year: FDA’s device registration renewal period! Beginning October 1 – December 31, 2023 , all foreign and domestic medical device establishments must register and renew their device establishment registration with FDA. This […]
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 […]
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 […]
★★★★★
Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.
I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.
Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.
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.
