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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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- Gun Violence Reduction Law Further Extends Moratorium on Trump-Era Rebate Rule June 27, 2022
- 10th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements is Just Days Away June 24, 2022
- Corporate Liability from Employee Diversion: Costly on Many Fronts June 22, 2022
- ‘Til I Hear It From Congress: FDASLA to Direct Publication of Final OTC Hearing Aid Rules June 22, 2022
- In Bid to Curtail 180-day Exclusivity, FDA Alters Longstanding Practice and Newly Declares that Converted OTC Products Are Not “Listed Drugs” June 21, 2022
- 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