|
|
- IVD and investigational product developers and manufacturers
- Medical device developers and manufacturers (e.g.,endovascular products, surgical devices, imaging systems, cardiac monitoring systems, instrumentation)
- Software medical device developers and manufacturers
- Dialysis systems and dialysate manufacturers
- Finished pharmaceutical manufacturers
- Bulk drug/active pharmaceutical ingredient (API) manufacturers
- Sunscreen/OTC manufacturers
- Contract testing laboratories
- Medical device and IVD manufacturers (Quality Systems compliance, design control processes, Part 11)
- Software manufacturers (Design control processes, validation practices, Part 11)
- Finished pharmaceutical and bulk drug/active pharmaceutical ingredient (API) manufacturers (Good Manufacturing Practices, Part 11)
- Contract testing laboratories (Good Laboratory Practices, laboratory GMPs, software validation, Part 11)
- Bioequivalence audits (generic drug comparatives)
- Blood bank software (standalone device)
- Radiation treatment planning software (accessory device)
- Chemistry analyzer software (device component)
- Digital imaging systems software (device component)
- Automated building management (environmental monitoring) systems (process software)
- Document management and control software (Quality Systems software)
- Complaint, defect tracking and CAPA software (Quality Systems software)
- Data acquisition systems, including clinical data and HPLC analysis (process software)
- Commercial Off-the-Shelf (COTS) software (process and Quality Systems software)
- Medical devices (examples: neurovascular, cardiovascular and peripheral vascular intervention, gamma-detecting probe, blood filtration system, ovulation indicator)
- Biological products (examples: monoclonal antibodies, activated lymphocytes, bioadhesives)
- Topical pharmaceuticals (examples: anti-fungal treatment, acne treatment)
- Oral pharmaceuticals (examples: anti-MS therapeutic, Parkinson’s disease therapeutic)
- Blood bank software [510(k)]
- Gamma-detecting probe [510(k)]
- Brachytherapy accessory device [510(k)]
- Valve suction irrigator [510(k)]
- Imaging diagnostic system for charged-particle radiation therapy [510(k)]
- Breast imaging systems [PMA]
- Radiolabeled monoclonal antibody [IND]
- Generic topical tretinoin [ANDAs / CMC Sections]
- Ocular diagnostic solution [505(b)(2)]
- Active pharmaceutical ingredients [US DMFs]
- Chemical medical device [US and EC DMFs]
|
|
