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When a 510(k) or PMA Goes Off Track – FDA’s Appeals Process
June 14, 2011The ability to successfully obtain FDA approval is critical to the success of a medical device. However, sometimes even the most dedicated of efforts fall flat when FDA says “No.” What then? What can you do if FDA says it believes there is not an adequate predicate device for your product? Or if FDA is requiring an overly burdensome clinical study? Or imposing data requirements that were not applied to your competitor's similar 510(k) six months earlier?
Hyman, Phelps & McNamara, P.C.'s Jeffrey K. Shapiro is presenting in a June 21, 2011 audio conference on the appeals processes available for medical device companies when FDA takes an adverse action during premarket review of a 510(k) or PMA. He will discuss practical tips and advice on how to resolve a dispute with FDA so that a 510(k) or PMA can move forward.
Details about the audio conference are available here. Sign up now!
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- FTC Continues to Rage Against Device Patent Listings in the Orange Book March 27, 2024
- FDA Approval of New Therapy, Duvyzat, for Duchenne Muscular Dystrophy Represents Several Meaningful Firsts March 26, 2024
- Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit March 25, 2024
- Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference March 22, 2024
- HP&M Director, Allyson Mullen, Appointed to the Association of Medical Diagnostic Manufacturers 2024-2026 Board of Directors March 20, 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