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Update: Court Dismisses Lawsuit Challenging FDA Decision in Device Reclassification Petition
April 15, 2009By Susan J. Matthees –
Last year we reported that FDA had moved to dismiss a lawsuit alleging that FDA had improperly denied HiFi DNA Tech, LLC’s (“HiFi’s”) petition for reclassification of an HPV nested DNA polymerase chain reaction detection device from Class III to Class II. The U.S. District Court for the District of Connecticut recently granted FDA’s motion to dismiss the case.
HiFi had submitted a 510(k) submission for its device, but FDA responded with a letter stating that the device would be classified as a Class III device and thus would require Premarket Approval from FDA. HiFi responded to this letter with a request that FDA reclassify the device from Class III to Class II, which FDA denied. HiFi filed a complaint in district court challenging FDA’s action.
In dismissing the case, the court concluded “that the FDA’s denial of HiFi’s reclassification petition is not ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.’” The court found that FDA gave HiFi’s petition a thorough review and responded to each of HiFi’s arguments. Further, because FDA was interpreting its own statutes and regulations when it made its decision, the court was “especially deferential” of the agency’s decision.
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- Feeling the Heat (or Cold) – New Draft Guidance Addresses Requirements for Devices that Produce Thermal Effects March 19, 2024
- Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3 . . . and PART 3½) March 14, 2024
- Drugs Companies Clap Back at Congress…Then Get Sued March 13, 2024
- Bad Labs! Bad Labs? Whatcha Gonna Do? March 12, 2024
- 15 Years Strong: Rare Disease Week’s Remarkable Journey of Support March 10, 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