FDA announces they will not regulate “low risk” general wellness devices

While mobile health apps and wearable devices have become exponentially more popular, FDA has explained they will not be regulating “low risk” general wellness devices. Traditionally, medical devices are required to obtain FDA approval or provide evidence of similarity to a preexisting product. In a new draft guidance entitled General Wellness: Policy for Low Risk Devices, the Agency has confirmed their decision not to regulate products classified as “low risk general wellness.” FDA defines such products as “solely intended for a general audience and presenting a very low risk to users’ safety.” Some examples provided in the guidance include exercise equipment, sleep, stress, or weight management devices, and other physical fitness products intended for recreational use.

For more information, read Alexander Gaffney’s article on RAPS.org here.

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FDA has released a draft guidance on its new approach for defining and classifying new medical device accessory types.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FDA releases draft guidance to help reduce driving impairment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 After issuing numerous warnings, FDA has released a new draft guidance entitled Evaluating Drug Effects on the Ability to Operate a Motor Vehicle.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.

New whitepaper from Pearl Pathways “Types of In Vitro Diagnostics: Clearing up the Confusion”

By definition, all in vitro diagnostics (IVDs) for human use are medical devices. That much can be easily understood: however, classifying medical devices under the IVD umbrella can become complicated when the difference between each category is often unclear. There are many roadblocks to bringing a medical device to market, but spending time on product classification and sifting through FDA guidance documents doesn’t have to be one of them.

Pearl Pathways has published a new whitepaper entitled “Types of In Vitro Diagnostics: Clearing up the Confusion.” The paper discusses the many categories of IVDs and their requirements and regulations. These categories include RUOs, IUOs, ASRs, LDTs, Companion Diagnostics, and IVDMIAs. This paper is a must read for anyone involved in the development of IVDs.

Click here to read!

Pearl Pathways to attend, present at 5th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference

Pearl Pathways is excited to be attending the Annual Clinical Affairs & Regulatory Approvals for Diagnostics Conference next week in Alexandria, VA. This conference provides a forum for discussion on the challenges regulators face and strategies used to successfully bring a companion diagnostic to market. This year’s attendees include FDA reviewers, accomplished industry representatives, and numerous regulatory experts.

We encourage you to stop by our booth to meet our talented staff. In addition, we invite you to join us for the Clinical & Regulatory Strategies for Companion Diagnostics Workshop on Wednesday, October 29. Pearl’s own Gretchen Bowker will be serving as the moderator for the 11:20 discussion on Establishing Realistic Timelines for Companion Diagnostics & Personalized Medicine Development.

Click here to register for the conference. We hope to see you in Alexandria on Monday!

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.