FDA Announces Progress Regarding Balancing Premarket and Postmarket Data Collection for PMAsMay 1, 2015
As part of its 2014-2015 Strategic Priorities, the Center for Devices and Radiological Health (CDRH) committed to assuring the “appropriate balance between premarket and postmarket data collection to facilitate and expedite the development and review of medical devices.” By December 31, 2014, it committed to reviewing 50% of the product codes subject to a Premarket Approval Application (PMA) to determine whether FDA could: (1) rely on postmarket controls to reduce premarket data collection, (2) shift some premarket data collection to the postmarket setting, or (3) pursue down-classification. FDA exceeded the 50% review target, and had reviewed 69% of product codes by December 31, 2014.
Of the Class III product codes reviewed (see here and here), FDA does not propose making changes to classification or the balance of premarket and postmarket data for the majority of devices—approximately 96 product codes. It does, however, propose down classifying to Class II the following 21 product codes:
Catheter, sampling, chorionic villus
Agent, absorbable hemostatic, collagen based
Applicator, hyperthermia, superficial, rf/microwave
Device, testicular hypothermia
Dilator, cervical, synthetic osmotic
System, rf/microwave hyperthermia, cancer treatment
Bone growth stimulator
Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Stimulator, salivary system
Condom, female, single-use
System, imaging, fluorescence
System, laser, photodynamic therapy
System, laser, fiber optic, photodynamic therapy
Assay, enzyme linked immunosorbent, parvovirus b19 igm
Assay, enzyme linked immunosorbent, parvovirus b19 igg
Analyzer, medical image
Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
Stent, urethral, prostatic, semi-permanent
Light source system, diagnostic endoscopic
FDA also proposes changing the data requirements for an additional 21 codes, and has specified the changes it anticipates for those devices. For example, for toric intraocular lenses, FDA has stated that issues for higher cylinder power (i.e., higher myopes) related to visual distortions have been documented in previously approved PMAs. For the approval to add a higher cylinder power lens to an already approved toric IOL platform, FDA is considering allowing a shift from premarket to postmarket for some clinical data requirements. For in vitro diagnostics (IVDs) intended to detect prostate cancer, or to distinguish between benign conditions and prostate cancer, FDA is considering requiring performance standards or nonclinical tests that have been developed as potential surrogates for some of the clinical testing. 15 of the 21 codes for which FDA is proposing to change the data requirements are for IVDs.
CDRH’s review and specific proposals for reducing premarket data collection are welcome. The key issue will be whether and when FDA takes the initiative to implement these changes.