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Promoting Your 510(k)-Pending Device: 5 Questions About FDA’s Policy
October 20, 2016For almost 40 years FDA has allowed device firms to promote their device while a 510(k) submission is still pending. Yet, questions about how to apply this policy still remain. In an article newly published in MedTech Insight, titled "Promoting Your 510(k)-Pending Device: 5 Questions About FDA's Policy," Hyman, Phelps & McNamara, P.C.'s Jeffrey K. Shapiro answers some of the most frequently asked questions.
Categories: Medical Devices
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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