Keeping Up with Medical Device Manufacturing and Digital Health – FDA Watch
Wayne chats with Cathy Burgess, Partner and Head of the FDA Compliance and Enforcement Team and FDA Practice at Alston & Bird, and Michael Gaba, Food and Drug Vice Chair at Polsinelli. You’ll hear their thoughts on what’s happening these days at CDRH; key issues for medical device manufacturers, such as QSMR implementation and enhanced cybersecurity requirements; the evolution of digital health and its impact on clinical decision support technologies and wellness products; what could be next for user fee authorization; potential risks with AI in medical devices; and much more.
Headlines
Pharma: FDA advisory panel votes to recommend allowing compounding pharmacies to prepare six peptides
Devices: FDA selects Dexcom as first participant in TEMPO pilot
Food: FDA issues final order revoking the authorization for two food dyes
Cosmetics: Survey notes nearly 73% of daily cosmetic users believe FDA tests cosmetics for safety
Resource Links
Pharma: Federal judge rules FDA’s 2023 REMS modifications for mifepristone were arbitrary and capricious
Devices: From MedTech Dive, Aidoc pursuing FDA authorization for generative AI-powered First Read software
Food: FDA announces FY2027 user fee rates for importers approved to participate in VQIP
About Our Guests
Cathy Burgess
Cathy Burgess leads the Alston & Bird’s FDA Compliance and Enforcement Team and FDA practice.
Cathy advises clients on a range of matters affecting prescription and OTC drugs, biologics, medical devices, foods, and cosmetics, and has extensive experience regarding current good manufacturing practice (CGMP) regulation and supply chain management. For products regulated under the Federal Food, Drug, and Cosmetic Act (FDCA), Cathy conducts liability risk assessments and works with clients to identify and analyze potential legal risks associated with their products. She advises clients on quality system remediation, inspection management, recalls, and responses to Form FDA 483s and warning letters. Cathy also conducts whistleblower investigations, special audits, and due diligence reviews related to FDA compliance. She assists clients in designing compliance programs, internal audit programs, and other risk mitigation strategies. She is recognized as a leading practitioner for life sciences in Who’s Who Legal, ranked in The Best Lawyers in America® in FDA and Food and Beverage Law, and ranked Band 1 in Chambers USA in Pharmaceutical/Medical Products Regulatory. Cathy is a recipient of the FDLI 2023 Distinguished Service and Leadership Award.
Before joining Alston & Bird, Cathy served as associate general counsel for the American Red Cross, where she was responsible for regulatory matters, and served as the Red Cross Office of General Counsel’s representative in negotiations related to the Red Cross amended consent decree.
Michael Gaba
Michael Gaba provides strategic FDA regulatory, Medicare policy, and federal relations counsel to an array of companies developing a variety of products in the life sciences space, whether traditional medical devices, digital health-based products, biotechnologies, biologic-device combinations, or pharmaceuticals. His primary goal is to bring companies to market and then help them remain there in the most efficient and effective manner possible.
Working as an extension of each company’s legal and business teams, Michael draws on nearly 30 years of experience to navigate the FDA pre-market regulatory pathways, counsel companies on FDA post-market compliance matters, and resolve Medicare coverage, coding, and reimbursement disputes with the Centers for Medicare and Medicaid Services. By using his FDA and CMS experience during the product development phase, Michael is able to help maximize companies’ opportunities to be appropriately compensated in the proper treatment venues, whether a physician’s office, hospital outpatient or inpatient departments, ambulatory surgical centers or home care.
During the COVID-19 pandemic, Michael provided strategic FDA counsel to many medical device and diagnostic companies, including several first-time entrants to the medical device space, helping them obtain emergency use authorizations from the FDA, and advising them on how to comply with FDA’s pandemic-focused enforcement discretion policies. Michael continues to advise these companies on transitioning to full FDA compliance in the post-pandemic environment.
There are times when federally-regulated life science companies and the patients they serve would benefit from changes to public policy, Michael works with members of Congress and Executive Branch officials to develop, enact and implement these policy changes.
FDA Watch Podcast 