- Surprise! Fifth Circuit Rejects DEA’s Longstanding Interpretation of a Pharmacist’s “Corresponding Responsibility” and “Usual Course of Professional Practice” Regulations February 26, 2026
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What Happens to Medical Device Reports Once They Reach FDA?
January 11, 2011Hyman, Phelps & McNamara, P.C.'s Jeff Shapiro published an article in this month's MD&DI magazine - What Happens to Medical Device Reports Once They Reach FDA? In the article, he summarizes a Office of Inspector General Report finding that FDA has not used medical device reporting ("MDR") data to improve medical device safety. He suggests that eliminating malfunction MDRs would significantly reduce the burden on industry and FDA, and would allow FDA to better focus on device problems that cause actual serious injuries or deaths.
Categories: Medical Devices
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- Surprise! Fifth Circuit Rejects DEA’s Longstanding Interpretation of a Pharmacist’s “Corresponding Responsibility” and “Usual Course of Professional Practice” Regulations February 26, 2026
- The Government’s Warning Shot? FDA and HHS Turn Up the Pressure on Compounding February 23, 2026
- Rare Disease Month Developments – Part 3: The Ugly (just kidding) – See You at Rare Disease Week February 20, 2026
- FDA’s Latest Nudge to Phase Out Petroleum-Derived Color Additives February 19, 2026
- Rare Disease Month Developments, Part 2 –The Bad: Proposed Closing of an Orphan User Fee “Loophole” & Renewed Concerns Regarding FDA Consistency February 18, 2026
- 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