Medical Device Pathways: Navigating FDA Roads to Market
If the FDA’s new definitions of “device” and “counterfeit device” are tripping you up … if you’re unsure whether your product is a medical device or a wellness product … if you struggle to determine which risk class your device falls into … the Medical Device Pathways management report will give you all the details you need to decide which FDA pathway to market authorization is the best choice.
Using straightforward information and real-world examples drawn from recent FDA enforcement activity, this management report will explain the submission requirements for each of the FDA’s five application paths, as well as the specific timelines, costs and conditions for approval for each one.
Management report takeaways:
- How to determine if the FDA would consider a product a medical device
- How to determine the right risk class for a device
- Exactly how the FDA regulates each risk class of device, including what the correct approval pathway is for new products
- The pros and cons of the main device approval pathways: 510(k) and premarket approval (PMA)
- What the FDA expects in terms of best practices for each of these approaches
- When less-common approaches — de novo, humanitarian device exemption (HDE) and custom device exemption (CDE) — may be suitable for a particular device
The FDA has been issuing more and more warning letters regarding new medical device launches. Avoid them — and find success — with Medical Device Pathways: Navigating FDA Roads to Market.
About the Contributor
Shelly Garg is president and founder of Garg Law, an FDA regulatory compliance law firm. She represents clients across a broad range of FDA-regulated product categories, including medical devices; OTC drugs; cosmetics and personal care products; and food, beverages and dietary supplements. She advises on strategic business planning, product development, testing and approval, labeling, advertising and promotion, liability risk, inspections, responding to regulatory enforcement matters, import/export matters and related issues.
Who Will Benefit
- Regulatory affairs managers
- Product development managers
- Import/export managers
- Quality control directors
- In-house counsel
- CEO/president, VP and other executives
- Employees/individuals in charge of overseeing product development portfolio
- Parties interested in legal launch of a medical device
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