New FDA Approach to Medical Device Accessory Regulation

FDA has released a draft guidance on its new approach for defining and classifying new medical device accessory types. Device accessories have previously been classified in congruence with the parent device or as a completely separate classification regulation. The new FDA approach intends to classify the risk of the device when used with the parent device, as intended. In theory, this will provide a more accurate risk classification for the accessory devices, thus assuring the safety and effectiveness of the device.

In order to get new medical device accessories to the market more promptly, the guidance suggests that manufacturers use the de novo classification process to classify new types of device accessories.

Need help mapping out the regulatory path for your medical device accessory? Contact us at contact@pearlpathway.com.

To read Alexander Gaffney’s full article on raps.org, click here.

FDA releases draft guidance to help reduce driving impairment

FDA has kept a close eye on psychoactive drugs—especially sleep aids—with concerns that many patients have experienced side effects well after the drug should have worn off, ultimately impairing their ability to safely perform activities such as driving, and causing accidents. After issuing numerous warnings, FDA has released a new draft guidance entitled Evaluating Drug Effects on the Ability to Operate a Motor Vehicle.

The guidance provides recommendations for all psychoactive drug manufacturers to assess their products’ impact on driving ability and demonstrate safety. FDA has also recommended “driving studies” with a “tiered” approach to properly evaluate the drug’s effect on a patient’s ability to operate a vehicle. The following categories have been provided to measure drug effects:

  • Alertness/arousal/wakefulness
  • Attention and processing speed
  • Reaction time/psychomotor functions
  • Sensory-perceptual functioning
  • Executive functions

The guidance provides additional information on how to conduct driving studies and urges pharma companies to review any data regarding their drug’s impact on a patient’s ability to drive.

To read FDA’s draft guidance, click here. For additional information, click here to read Alexander Gaffney’s article from RAPS.org.

FDA announces medical device guidance documents to be released in 2015

The FDA’s Center for Devices and Radiological Health has recently released a list of all medical device guidance documents it plans to release in 2015.  The list, also known as the “Guidance Agenda,” outlines the federal laws and regulations that are planned to be enforced and published by FDA this year. The list is prioritized and divided into two lists, an “A-List” and a “B-List,” with the “A-List” taking precedence.

The list is comprised of 28 device guidance documents including software and diagnostics. Top priority documents are related to regulating lab-developed tests (LDTs) and speeding up device submissions.

For more information, read Alexander Gaffney’s article from raps.com. To view the Guidance Agenda on FDA’s website, click here.

FDA announces requirements for compounding pharmacies

According to a recent announcement, FDA will require large compounding pharmacies to register annually, pay a $15,000 annual fee, and report a list of all manufactured products every six months. These requirements were established in three guidance documents, explaining how to comply with the regulations for outsourcing facilities.

A few key takeaways from the guidances include:

  • Compounders may withdraw their registration
  • Any registered compounder must re-register each year between October 31 and December 31
  • All outsourcing facilities must register and submit product reports through FDA’s electronic submission process. Email submissions will no longer be accepted.

FDA estimates at least 1,000 U.S. large compounders are eligible for registration; 51 have registered so far.

For more information, read Robert King’s article from FDAnews.com here.

Pearl Pathways attending, sponsoring IMDMC annual conference – November 6

imdmcPearl Pathways is excited to be attending and sponsoring the IMDMC Annual Conference tomorrow, November 6 at the Montague Banquet Center in Indianapolis. This conference provides an opportunity for networking, collaboration, and discussion of recent news and trends within the medical device industry. Dr. Kimber Richter from the FDA Office of Compliance will present this year’s keynote speech on “FDA Assessment of Risk/Benefit in the post Market/Recall Space.”

When: Thursday, November 6

Where: Montague Banquet Center, 8580 Allison Pointe Blvd, Indianapolis, IN

We encourage you to stop by our exhibitor booth to meet our talented staff! For more information about IMDMC, click here.

New FDA guidance says new fixed-dose combination drugs are eligible for exclusivity

For the first time, FDA is allowing new fixed-dose combination (FDC) drugs to be eligible for five years of New Chemical Entity (NCE) exclusivity. FDA currently provides market-based exclusivity to pharma companies who have been approved to market new drugs, granting them patent protection and disapproving any outside equivalents over a five-year period. Until now, FDC drug products have been ineligible for five-year exclusivity if they consist of any previously approved entities.

FDA has recently released a final guidance document outlining the new standards for exclusivity. While industry’s reaction was seemingly positive, many companies have expressed concerns with the new policy’s lack of retroactivity. FDA explains in the guidance that these new exclusivity standards will only be effective as of October 10, 2014, which is when the document was published, meaning that FDC drugs with prior approval will remain ineligible for this exclusivity.

To learn more, read Alexander Gaffney’s article on raps.org. Click here to read FDA’s final guidance.

FDA moves to reduce cybersecurity threats in medical devices

FDA has released a final guidance document and collaborated with the National Health Information Sharing & Analysis Center (NH-ISAC) as part of their effort to protect patient privacy and prevent cyber-security threats in medical devices. The guidance suggests that manufacturers identify potential security risks and submit action plans to FDA to reduce vulnerability.

FDA’s additional partnership with the NH-ISAC will help foster the relationship between healthcare providers and security experts and provide programs to further minimize cyber-security threats. These threats came to light last year when two Department of Homeland Security researchers discovered a hard-coded password vulnerability affecting approximately 300 medical devices.

Click here to read Patrick Ouellette’s article on healthitsecurity.com. For additional information, read FDA’s final guidance and memorandum of understanding with the NH-ISAC.

New FDA study to examine the effects of distractions in drug ads

FDA has been granted approval to move forward with a May 2014 study proposal to analyze the effects of distractions in drug advertisements. In the study announcement FDA explains, “We hypothesize that distracting audio and visuals during the major statement will decrease risk recall, risk perceptions, and attention to superimposed text risk information.”

To conduct the study, FDA has created two drug advertisements: one with minimal distractions and the other with significant distractions. As each ad plays, the viewers’ eye positioning and movement will be examined to determine if the major risk statement is appropriately recognized.

Click here to read FDA’s study announcement. For additional information, refer to Alexander Gaffney’s article on raps.org.

FDA announces new “Purple Book” for biological products

Similar to the pharmaceutical “Orange Book,” FDA has recently published the first edition of the “Purple Book” of biological products, which is intended to provide the regulatory community with information on the interchangeability of biosimilars.

The book is divided between two sections: products approved by the Center for Drug Evaluation and Research (CDER) and products approved by the Center for Biologics Evaluation and Research (CBER), and contains information such as the BLA number, product name, date of licensure, reference product exclusivity date, withdrawn, and more. In addition, FDA has proposed a four-tier assessment for biosimilar interchangeability, which presents the implication that not all products approved through the 351(k) biosimilar process will be considered interchangeable by the agency’s standards.

Although the U.S. market for biosimilar products is relatively small, FDA expects to see many additions to the Purple Book in the near future.

Click here to read Alexander Gaffney’s full article from RAPS.org.

FDA proposes to exempt 107 medical devices with new draft guidance

In an effort to simplify the approval process for low-risk medical products, FDA has exempted 107 medical devices from its 510k premarket notification regulations. This list was released as part of the August 1st draft guidance, allowing devices that are “sufficiently well understood and do not present risks that require premarket notification review to assure their safety and efficacy” to be marketed without a 510k submission, given that the device meets all other regulatory requirements.

FDA has granted exemptions for medical devices such as portable air compressors, fluid-filled teething rings, surgical lights, and obstetrical forceps.

To read Joseph Keenan’s article on Fierce Medical Devices, click here.