CDRH Information Tracker
FDA's Center for Devices and Radiological Health has a lot to say about how you make and market your medical devices. Here's a brief synopsis of recent Federal Register notices and guidance documents from the Center. You might also be interested in the monthly summaries of 510(k) and PMA final decisions. You can also read FDA's semiannual list of planned guidance documents or the quarterly list of all guidance documents issued and withdrawn. We've also assembled a list of useful CDRH databases, including the releasable 510(k)s, product codes, and MDRs. Designers of telemetry-based products might be interested in CDRH's Wireless Medical Telemetry Service. Manufacturers hoping to bypass the agency as much as possible can view the list of devices eligible for third-party review. And if all else fails, you can send an e-mail message directly to CDRH director David Feigal at director@cdrh.fda.gov.
Last update: Jan. 19, 2001
Federal Register Notices | |
|---|---|
| Medical Devices; Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures | FDA is proposing regulations under which it may rescind a 510(k) decision. In addition, under this proposal, a 510(k) holder may request administrative review of a proposed rescission action. This proposed rule is being issued in order to standardize the procedures for considering rescissions.(66 FR 10, Jan. 16, 2001) |
| Expansion of Medical Devices Industry Initiatives | FDA is changing its standard practices for medical device inspections based on the outcome of the expansion of the medical device industry initiatives pilot program. FDA is discontinuing post-inspection notification letters for all inspections because the agency now provides inspected establishments with a copy of the establishment inspection report when the inspection is deemed closed. FDA will maintain pre-announced inspections and annotations of the inspectional observations as standard practices for medical device inspections, but with respect to inspections of other program areas, FDA will apply these initiatives at the discretion of district management. (66 FR 3, Jan. 4, 2001) |
| Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications | A list of PMA's that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs. (65 FR 242, December 15, 2000) |
Guidance Documents | |
| Class II Exempt Special Controls Guidance for Various Orthopedic Fixation Devices; Final Guidance for Industry | FDA has determined that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of the various orthopedic fixation devices identified in Appendix I of this guidance. Instead, FDA has determined that special controls, when combined with the general controls, are sufficient to support the exemption of these devices from 510(k) requirements. FDA’s decision to grant exemption from 510(k) requirements for the various orthopedic fixation devices identified in Appendix I is based upon the existing and reasonably foreseeable characteristics of the commercially distributed devices within those generic devices types. (Jan. 11, 2001) |
| Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final Guidance for Industry and FDA | Describes a means by which cardiopulmonary bypass arterial line blood filter devices may comply with the requirement of special controls for class II devices. The document has been developed as a special control to support a change in classification from class III to class II. It identifies relevant material on preclinical studies and labeling to include in a 510(k) premarket notification application. (December 11, 2000). |
| Deciding When To Submit A 510(k) For A Change To An Existing Wireless Telemetry Medical Device Final Guidance for FDA Reviewers and Industry | Provides help in deciding when to submit a 510(k) for a change to an existing wireless telemetry medical device or to a medical device incorporating wireless telemetry as a feature, as a result of the recent FCC rule which designates certain frequency bands as "protected" bands for Wireless Medical Telemetry Service and establishes rules for their use. (December 8, 2000). |
| Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff (PDF) | Describes how cardiopulmonary bypass oxygenator devices can comply with the requirement of special controls for class II devices. Designation of this guidance document as a special control means that manufacturers attempting to establish that their device is substantially equivalent to a predicate cardiopulmonary bypass oxygenator device should demonstrate that the proposed device complies with either the specific recommendations of this guidance or some alternate control that provides equivalent assurances of safety and effectiveness. (November 20, 2000). |
