Normativa y cumplimiento de la FDA

FDA Regulatory and Compliance Attorneys | Guiding Companies from Concept to Compliance

Kirton McConkie’s U.S. Food and Drug Administration (FDA) regulatory team guides emerging and established medical device, pharmaceutical, biotechnology, food, dietary supplement, nutraceutical, and cosmetic companies through every step of the FDA-regulated product lifecycle, including early-stage product development, pre-clinical and clinical trials, strategic interactions with regulators, premarket product approval and clearance pathways, and aftermarket compliance obligations.

We leverage our team’s extensive experience in government and industry, along with our extensive international network, to advise clients on complex FDA regulatory and compliance issues, including:

  • Assisting companies developing innovative medical products (drugs, biologics, and medical devices) with regulatory strategy during early state development through FDA premarket submissions.
  • Advising companies on FDA establishment registration and listing requirements.
  • Guiding innovative medical device manufacturers through the Breakthrough Device Designation request process.
  • Counseling medical device manufacturers on FDA premarket approval and clearance pathways, e.g., 510(k)s, de novos, premarket approvals (PMAs), and Emergency Use Authorizations (EUAs).
  • Advising medical device companies with Quality System Regulation (QSR/QSMR) and ISO 13485 compliance.
  • Advising companies responding to FDA inspections and administrative actions (i.e., FDA 483s, warning letters, and untitled letters).
  • Advising on medical device reporting (MDR) and product recall compliance.
  • Negotiate with FDA’s import officials and U.S. Customs and Boarder Protection (CBP) to secure the release of detained FDA-regulated products.
  • Advise pharmaceutical and medical device clinical trial sponsors regarding listing compliance with clinicaltrials.gov reporting.
  • Advising pharmaceutical and medical device manufacturers on state licensing and permit requirements.
  • Advising food and food packaging companies on the regulatory status of food ingredients, generally recognized as safe (GRAS) submissions, dietary supplement ingredient notifications, and food contact substances and packaging materials.
  • Assisting investors and investment funds with preliminary and ongoing due diligence surrounding portfolio companies and their transactional and licensing work.
  • Assisting international manufacturers with their FDA-related obligations.

Our attorneys have held positions at the FDA and other federal agencies in Washington, DC, and on Capitol Hill and can provide effective counsel on FDA policy, legislative matters, and administrative governmental affairs. Our team has experience advising on federal, state, and local legislative strategies, writing comments on proposed rulemakings, and supporting clients with administrative hearings and panel meetings.

 

We work closely with our corporate and international trade teams to advise on regulatory aspects of M&A (mergers and acquisitions) transactions, and private equity and capital markets transactions. We also assist our clients with international product and precursor sourcing and supply chain restructuring, evaluating and procuring insurance, and conducting due diligence around the world. We also work with our litigation teams to defend against administrative overreach and medical device malpractice claims.

Contactos de la práctica
J. Seth Olson
J. Seth Olson
solson@kmclaw.com
801.328.3600
Abogados en ejercicio
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