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CDRH Reorganizes its Office of Device Evaluation
November 7, 2012CDRH recently announced that, as of November 1, 2012, the Office of Device Evaluation ("ODE") has been reorganized. There are two new divisions—the Division of Surgical Devices and the Division of Neurological and Physical Medicine Devices—and 12 new branches across all seven review divisions.
CDRH stated that the intent behind the reorganization is to “reduce the manager to staff ratios and better align product areas as well as accommodate the new MDUFA hires that will be coming into the Center.” CDRH has hired some staff to help fill the newly created manager positions, though “it is anticipated that a good portion of the positions will likely be filled with existing staff.” Until new staff is in place, CDRH “did not want to create voids in the review positions that would impair [its] ability to meet performance goals.” In the coming weeks, CDRH will be advertising and interviewing to fill the new positions.
In addition to the new divisions and new branches, FDA will also shift the responsibility for reviewing “30-day notices” regarding changes to cardiac devices from the Office of Compliance to ODE’s Division of Cardiovascular Devices. This change is expected to take place beginning January 1, 2013.
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- FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications April 26, 2024
- OMB Completes its Review of the Final LDT Rule—A Final Rule Coming Anytime Now April 25, 2024
- Senators to DEA: Consider Treaty Obligations In Marijuana Rescheduling April 23, 2024
- “Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application . . . And a Corrected NDA Approval Letter is No Saving Grace April 22, 2024
- Clear that Cabinet Tour ‘24 April 18, 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