- Area of Interest Funding – “There’s Always Money in the Banana Stand” March 3, 2021
- OPDP Issues Second Warning Letter of 2021. But Wait, Where Did the OPDP Warning Letters Go? March 2, 2021
- Beware EUA Deprioritization! February 25, 2021
- Getting Into the Weeds of USDA’s Hemp Production Program Regulations February 24, 2021
- “Tongue and Done” – Just . . . No. February 18, 2021
- 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
More Members of Congress Concerned About 510(k) Reform
January 4, 2011By Jeffrey K. Shapiro –
A group of nine U.S. Senators has sent a letter to FDA expressing concern over potential changes to the 510(k) medical device clearance program. The letter is similar to a November 2010 letter from Minnesota lawmakers and an October 2010 letter from House lawmakers (see our previous posts here and here). Each letter takes issue with FDA’s August 2010 report recommending changes to the 510(k) program, which we reported on last year.
The Senatorial letter points to several “controversial” recommendations that “have the potential to disrupt the current regulatory balance under the 510(k) pathway, jeopardizing patients' timely access to new treatments and cures.” In particular, the Senators “believe that the recommendations regarding rescission authority; split and multiple predicates; intended use and indications for use; splitting Class II; and the treatment of proprietary information, including trade secrets could have significant unintended adverse consequences on the existing regulatory process.”
Search FDA Law Blog
Subscribe
Enter your email address to automatically receive new posts to the FDA Law Blog via e-mail.
Latest Tweets
Tweets by @fdalawblogAwards & Honors
- The Best
Lawyers in America
US News & World Report - Ranked in Chambers USA 2018
- Area of Interest Funding – “There’s Always Money in the Banana Stand” March 3, 2021
- OPDP Issues Second Warning Letter of 2021. But Wait, Where Did the OPDP Warning Letters Go? March 2, 2021
- Beware EUA Deprioritization! February 25, 2021
- Getting Into the Weeds of USDA’s Hemp Production Program Regulations February 24, 2021
- “Tongue and Done” – Just . . . No. February 18, 2021
- 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