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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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- AI May Make Your Device More Efficient, but Be Prepared to Spend More Time on Design Documentation February 5, 2025
- Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program February 4, 2025
- Pharmacy Law and Licensing Highlights 2025 February 3, 2025
- FOIA Requires Transparency of Instructions to FDA Staff, Even When Those Instructions Are to Pause Communications with the Public January 31, 2025
- When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities January 30, 2025
- 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