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Category: Medical Devices

When International Compliance Gets a Pop Quiz!

05/08/2025

FDA Announces Expanded Use of Unannounced Foreign Inspections

How to Handle Import Rejection Like a Pro

FDA Doesn’t Send Love Letters

02/18/2025

How to Handle Import Rejection Like a Pro

Double Trouble!

08/27/2024

Navigating USDA Permits for FDA-Regulated Products

Fee-Fi-Fo-FDA: New Device Fees on the Horizon!

08/05/2024

The U.S. Food and Drug Administration (FDA) has announced its new medical device user fees for fiscal year 2025, effective October 1, 2024, highlighting significant

Unlocking International Markets

07/09/2024

The Magic of FDA Export Certificates Including New Requirements for Dairy Exports to India

Sip Happens

05/29/2024

The Wild Waters of an FDA Recall

FDA’s New Final Rule on LDTs

05/08/2024

A Paradigm Shift in the Regulation of Diagnostic Devices

The FDA Import Detention Marathon

04/23/2024

An Endurance Test of Paperwork and Patience

FDA’s Updated Approach to the 510(k) Premarket Notification Process for Medical Devices

04/15/2024

Enhancing Safety and Efficiency

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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.

R.G.Client

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.

Mike H.Client

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.

Dr. SastryClient

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.

Claire P.Client

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