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FDA Postponement of 2008 Annual Registration for All Registered Medical Device Establishments
June 29, 2007The FDA announced it is postponing the annual registration of medical device establishments for 2008. The agency said this is a temporary action and it expects to resume annual registrations in October or November 2007. Establishments that are already registered for 2007 are valid until Dec. 31.
The FDA said it is postponing registration because "upcoming changes may significantly change the way [device manufacturers] register . . . establishment[s] and list . . . devices," including the possibility of electronic registration and listing, simpler registration and listing requirements and provisions under the Bioterrorism Act and the Medical Device User Fee and Modernization Act.
FDA also said that it is working to revise its registration and listing regulations to help foreign establishments meet the statutory requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188, the “Bioterrorism Act”), which requires each foreign establishment to provide, as part of its registration, the name of each known importer of the establishment’s devices and the name of each person who imports or offers to import the device into the United States.
Manufacturers with questions should call (240) 276-0111 or send an email to device.reg@fda.hhs.gov.
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- We Have an LDT Proposed Rule! September 29, 2023
- Fool Me Once, Shame on You. Fool Me Twice and It’s a Federal Felony—Always? September 29, 2023
- Clinical Trial Diversity: Understanding the Effects of the New Federal Guidelines on Your Clinical Trials September 29, 2023
- FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA September 28, 2023
- Hyman, Phelps & McNamara, P.C. Names Jeff Grizzel Chief Marketing Officer September 26, 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