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FDLI’s New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA, and 21st Century Cures
February 8, 2018By Hyman, Phelps & McNamara, P.C. —On Friday, February 9, 2018, from 2:00-3:30 PM ET, the Food and Drug Law Institute (“FDLI”) will be hosting a webinar, titled “New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA, and 21st Century Cures.” Hyman, Phelps & McNamara, P.C.’s Jeffrey N. Gibbs will be moderating the webinar.
As the title of the webinar suggests, several important pieces of FDA legislation have recently been enacted that significantly affect the medical device industry. FDA has been busy implementing the new laws, issuing numerous final and draft guidance documents and policies. These developments directly affect device companies:
- Implementing changes in device inspections to make them more risk-based
- Establishing pilots for the use of Real World Evidence
- Issuing new checklists for de novo submissions
- Evolving approaches for patient preference information
- Developing guidance in the digital health space
- Streamlining MDR reporting, and more
Keeping up with the array of changes and proposed changes is challenging. Join a panel of industry and agency experts for a status update on what’s happened already, what’s coming, and where medical device companies should be focusing their efforts.
You can register here for the webinar.
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- Clear that Cabinet Tour ‘24 April 18, 2024
- The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation” April 17, 2024
- Does the Drug Shortage White Paper Fall Short? April 9, 2024
- OPQ’s 2023 Annual Report: an Upbeat Review of CDER’s Quality Efforts April 8, 2024
- FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah) April 3, 2024
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized