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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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- HPMers Slated to Speak at FDLI’s Enforcement, Litigation and Compliance Conference December 1, 2023
- Are Predetermined Change Control Plans on the road to Global Harmonization? November 30, 2023
- FDA Stealthily Convenes Multi-Cancer Testing Panel Meeting November 28, 2023
- Silence Isn’t Golden: Two Executives Convicted in First Criminal Prosecution Under the Consumer Product Safety Act November 28, 2023
- FDA Proposes to Ban Brominated Vegetable Oil in Food November 23, 2023
- 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