Devices

Confirm DaVinci Surgical System Status: Petition

Harmed Americans for Reform in Medical Device Safety (HARMS) is asking FDA to confirm that robotic surgical systems are investigational when used in nipple-sparing mastectomies. The advocacy group’s 10/31 petition says clarification is needed because of an apparent inconsistency between the agency’s clearance of the da Vinci SP Surgical System “for use in nipple-sparing mastectomy procedures,” and another agency statement that “there is little evidence on the safety and effectiveness of the use of RAS (robotically-assisted surgical) devices in patients undergoing mastectomy for the prevention or treatment of breast cancer, and FDA has not granted any RAS device marketing authorization for mastectomy.”

The petition says the statements are confusing to hospitals, physicians, and, most of all, patients. “It is difficult to parse what the labeled indication actually means, especially given the scarcity of data supporting authorization concerning patients with cancer,” it says. “In fact, a growing number of medical centers have started advertising robotic mastectomy as being a safe, effective, and even ‘FDA-approved’ means of treating or preventing breast cancer.”

HARMS specifically asks that FDA:

confirm that robotic surgical systems are investigational when used in nipple-sparing mastectomy for the prevention or treatment of breast cancer;
promptly communicate its position in a public health communication, a letter to healthcare providers, a medical device safety alert, and any other communications it deems necessary to protect the public health; and
require the manufacturer to update its label to say, “This device is not authorized for use in patients for the prevention of breast cancer or in patients with breast cancer. The safety and effectiveness of the da Vinci for use in the prevention of breast cancer or for use in patients with breast cancer have not been established.”

AstraZeneca Petition Seeks to Block Cipla's Generic Lynparza

AstraZeneca has petitioned FDA to withhold approval of a Cipla ANDA for proposed new strengths of generic Lynparza (olaparib) tablets unless the generic company provides additional evidence addressing formulation differences, tablet size and potential medication errors. Lynparza, a PARP inhibitor approved for certain ovarian, breast, pancreatic and prostate cancers, is

Tidmarsh Sues Aurinia, Alleges Prasad Role in FDA Ouster

Former CDER director George Tidmarsh has filed a defamation lawsuit against Aurinia Pharmaceuticals and biotech investor Kevin Tang, alleging that they provided false accusations of bribery and abuse of regulatory authority to senior FDA officials a year ago, triggering his removal from the agency. The 23-page complaint (see below)

ICH M15 Model Evaluation Flexibility, Submission Requirements

Drug sponsors are not required to submit model analysis plans in advance under the new ICH M15 guideline on model-informed drug development (MIDD), and models that fail to meet predefined validation criteria are not necessarily disqualified from supporting regulatory decisions, international regulatory experts said during an 10/29 FDA-

FDA Warns of Ventilation Failures in ButterflyBVM Resuscitators

FDA has issued an Early Alert concerning a potentially high-risk defect in Compact Medical's ButterflyBVM bag-valve-mask resuscitators that could cause inadequate ventilation, hypoxia, serious injury or death. The agency said Compact Medical is removing certain lots of the single-use devices and requiring additional pre-

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AstraZeneca Petition Seeks to Block Cipla's Generic Lynparza

Tidmarsh Sues Aurinia, Alleges Prasad Role in FDA Ouster

ICH M15 Model Evaluation Flexibility, Submission Requirements

FDA Warns of Ventilation Failures in ButterflyBVM Resuscitators