WebFeb 28, 2024 · CDRH Petitions. A petition is a way for individuals, regulated industry or consumer groups to petition the agency to issue, change or cancel a regulation, or to take other action. The agency receives about 200 petitions yearly. Additional information about petitions can be found on the page: Making Your Voice Heard at FDA: How to Comment … WebMar 16, 2024 · CDRH Inspections Database. Metadata Updated: March 16, 2024. The CDRH Inspections Database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present.
An Overview of FDA Regulations for Medical …
WebSep 6, 2024 · For specific phone numbers and email, see the CDRH Management Directory by Organization. For general questions about medical devices regulation, contact the … WebJun 17, 2024 · Contact Us. For specific phone numbers and email addresses for each office, division, and branch, see the CDRH Management Directory by Organization. For … bradford locala sexual health
Current List of FDA-Recognized 510 (k) Third Party Review …
WebJul 6, 2024 · FDA recognition of ASTM F899-12b [Rec# 8-343] will be superseded by recognition of ASTM F899-20 [Rec# 8-527]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-343] until July 9, 2024. After this transition period, declarations of conformity to [Rec# 8-343] will not be accepted. WebThis standard is recognized on a scientific basis: Biocompatibility. This standard is recognized in part because: Subclause 5.2 and Annex A contain test method and/or specification that is not scientifically acceptable. Subclause 5.2 and Annex A are in conflict with existing published final guidance. Public Law, CFR Citation (s) and Procode (s)*. WebFDA User Fee Organization Number: 664743 Official Correspondent Lawrence Kluge SLK ORTHO LLC 5883 RFD Long Grove, IL 60047 Phone: (847) 630-1818 Email: … bradford local authority number