General Requirements for When a PMA Supplement is Needed Examples of the types of modifications that require a PMA supplement (21 CFR 814.39(a)), if such changes affect the safety or effectiveness of the device, include, but are not limited to, the following: 1) new indications for use of the device; 2) labeling changes; 3) the use of a different facility
Management Consulting | Management Consultants | 360 View We provide management consulting (360 views) to corporate management helping startups, young pharma, and device companies. How we do: We use our confidential and proprietary systematic assessment systems developed over the years. We consider and use all factors for accurate and precise assessment under the circumstances. We identify root causes. We
Good Clinical Practice for Medical Devices FDA | GCP | Medical Devices | ASRs | LDTs | IDEs | HDE | Sponsors | IRBs | CIs | Informed Consent | 21 CFR Part 11 | HIPPA | DMC | ICH General 21 CFR 50.54, Process for Handling Referrals to FDA under, Guidance for Clinical Investigators, Institutional Review Boards and Sponsors
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