FDA Pathways to Bring your Medical Device to Market: What Regulatory Professionals Need to Know – Webinar Recording/Transcript
Product Details
How confident are you that your product is subject to — or exempt from — the FDA’s premarket compliance requirements?
Between new FDA medical device guidance and a rise in the number of warning letters citing premarket approvals and product launches, you must be even more careful if you hope to meet all legal and regulatory requirements for launching your product.
This presentation shows you how.
Shelly Garg, president and founder of the FDA regulatory compliance law firm Garg Law, shares everything you need to know, including how to minimize or control for any regulatory risk.
She explains the device marketing requirements and the various benefits, challenges and drawbacks associated with different regulatory pathways, teaching you how to identify the nuances of each, understand your compliance obligations and determine the appropriate pathway for your product and your company, factoring in your timeline for clearance, costs and other conditions for approval.
And she helps you understand the FDA’s recent enforcement activity so you can steer clear of a similar fate.
You’ll be empowered to ensure your company meets all regulatory requirements so you can successfully market your product, reduce the chances of regulatory enforcement, avoid import delays and maintain consumer confidence.
Presentation Takeaways:
- How a device is classified by the FDA
- How to determine whether your company’s product is a medical device and how the FDA intends to classify and regulate it
- Features, benefits, challenges and drawbacks of device marketing pathways, including premarket notification 510(k), Premarket Approval (PMA), De Novo, Humanitarian Device Exemption (HDE) and Custom Device Exemption (CDE)
- Best practices and what the FDA is looking for in each pathway approach
- What the FDA means when it discusses why you need to understand risk
- What the FDA’s most recent guidance (November 2022) really means and how it intends to reference the terms “device” and “counterfeit device” provisions
- Why the FDA’s August 2022 warning letter — CMS #630567, issued to a cosmetic device manufacturer advising that the company’s products are devices under Section 201(h) of the FDCA and are adulterated for failure to have a PMA in place — may impact its regulation of medical devices
Want to successfully and intentionally launch your product? You must understand, implement and abide by all compliance requirements. This presentation will get you there.
Meet Your Presenter
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 in 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
Employees/individuals in charge of overseeing a company’s product development portfolio and parties interested in the legal launch of a medical device, including:
- Regulatory affairs managers
- Product development managers
- Supply chain operations managers
- Import/export managers
- Quality control directors
- In-house counsel
- CEOs/presidents, vice presidents, etc.