viernes, 1 de mayo de 2015

FDA Law Blog: FDA Announces Progress Regarding Balancing Premarket and Postmarket Data Collection for PMAs

FDA Law Blog: FDA Announces Progress Regarding Balancing Premarket and Postmarket Data Collection for PMAs

Posted: 30 Apr 2015 06:50 AM PDT
By Jennifer D. Newberger –

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:

Product CodeDescription
LFDSaliva, artificial
LLXCatheter, sampling, chorionic villus
LMFAgent, absorbable hemostatic, collagen based
LNCApplicator, hyperthermia, superficial, rf/microwave
LOADevice, testicular hypothermia
LOBDilator, cervical, synthetic osmotic
LOCSystem, rf/microwave hyperthermia, cancer treatment
LOFBone growth stimulator
LPQStimulator, ultrasound and muscle, for use other than applying therapeutic deep
LTFStimulator, salivary system
LZRUltrasound, cyclodestructive
MBUCondom, female, single-use
MRKSystem, imaging, fluorescence
MVFSystem, laser, photodynamic therapy
MVGSystem, laser, fiber optic, photodynamic therapy
MYMAssay, enzyme linked immunosorbent, parvovirus b19 igm
MYLAssay, enzyme linked immunosorbent, parvovirus b19 igg
MYNAnalyzer, medical image
NXGFluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
NZCStent, urethral, prostatic, semi-permanent
OAYLight 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.

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