FDA issues draft guidance on appeals process

FDA issues draft guidance on appeals process

The FDA today released draft guidance clarifying existing recommendations for how medical device manufacturers can appeal the federal watchdog agency’s decisions on marketing applications.

The draft guidance, which the FDA is asking industry to comment on over the next 90 days, pertains to requests for documentation of rationales for significant decisions and requests for supervisory review of regulatory decisions and actions taken by the FDA’s Center for Devices & Radiological Health.

The draft defines what a "significant decision" is, something that was previously not specified. Significant decisions are now restricted to 510(k): not substantially equivalent or substantially equivalent; PMA/HDE: not approvable or approvable with conditions; approval IDE: disapproval or approval; or
failure to reach agreement on a protocol.

The agency does not believe that actions earlier in the review process constitute "significant decisions." Thus, the FDA is not required to respond to appeals to any of the following: Refusals to accept/file, requests for additional information, or deficiency letters during the review of a premarket submission.

The FD&C Act requires the FDA to provide, upon request of a person who is seeking to submit or who has submitted a 510(k), PMA, IDE, or HDE, a "substantive summary" of the scientific and regulatory rationale for any significant decision regarding the submission, including documentation of significant controversies or differences of opinion and the resolution thereof, the draft guidance stated.

For example, anyone who submits a 510(k) receives either a substantially equivalent or not substantially equivalent decision from CDRH. The submitter may then request, and CDRH must provide, a substantive summary of the rationale for the decision.

According to the draft guidance, the substantive summary may be the final version of the review memorandum by the lead reviewer or another summary document that includes the following elements: an explanation of the rationale for the regulatory decision; documentation of significant controversies or differences of opinion, i.e., ones the 
resolution of which had a direct bearing on the regulatory decision; and, references to published literature and consensus standards upon which the decision-maker relied. 

In addition, the draft guidance spells out timeframes for the appeals process. Device marketing applicants are entitled to request a supervisory review of the significant decision made with regard to their device application within 30 days of the decision, in which they must indicate whether they want an in-person meeting or a teleconference review, according to the federal watchdog.

The FDA then has 30 days to respond to the request, and has 45 days after the initial request is made to issue a decision. In cases where an in-person meeting or teleconference has been requested, the agency has up to 30 days after such meeting or teleconference to issue a decision.

The draft guidance noted that these timeframes do not apply in cases that are referred to experts outside of the FDA.

Also, the review may be conducted at the next supervisory level or higher above the individual who made the significant decision, the FDA stated.

Additionally, the draft guidance clarifies that the FDA will only provide these summaries to the owner of any proprietary information, so there should be no need to withhold trade secret or confidential commercial information or any other information in the summary.

Anyone other than the device owner (generally the device sponsor or manufacturer) would need to file a FOIA request to obtain an executive summary of a significant decision. The FDA clarifies that it would withhold trade secret and confidential commercial information, but is not required to withhold any other information.

The agency noted that it developed this draft guidance as a companion to its current appeals guidance. When finalized, the agency intends to include the questions and answers in this draft guidance as an appendix to the appeals guidance.

RSS From Medical Design & Outsourcing

  • Athermal laser machining cuts bioabsorbable polymers and more
    A the recent MD&M East trade show in New York, Norman Noble, discussed the capability of athermal laser manufacturer. The company has developed the Noble S.T.E.A.L.T.H. (System To Enable Ablation Laser Technology Haz-free). The athermal laser machining process was developed to create precise features in any material, including bioabsorbable polymers, shape memory metals and other […]
  • Exciting possibilities for metallic glass in the medical device world
    Researchers are exploring the potential of metallic glass as a versatile, pliable material that is stronger than steel, with a bevy of possible medical device applications. Yale University engineers have discovered a unique method for designing metallic glass nanostructures across a wide range of chemicals, a technique that could have applications for everything from watch […]
  • Strong Precision Technologies’ medical divisions to unify under MedTorque brand
    Strong Precision Technologies announced on July 2, 2015, that its two medical divisions will now go to market under a single brand, MedTorque. The move reflects the increasing integration of the division formerly known as Inland Midwest with MedTorque, its sister division in Kenosha, WI. “We will continue providing our customers with the personalized level of service […]
  • Olympus offers next-day product replacement guarantee for medical devices
    Olympus, a medical and surgical procedures solutions company, announced that it is guaranteeing next-day replacements for surgical equipment at no additional charge. Olympus is the first surgical product manufacturer to offer this type of guarantee. The service became available to customers with an Olympus Full Service Agreement earlier this year. “Canceled procedures can be costly for healthcare facilities […]
  • More accurate prediction on prognosis in multiple myeloma from SkylineDx
    SkylineDx, a biotechnology company specializing in the development and commercialization of genetic tests, is launching its MMprofiler assay. This test enables clinicians to more accurately predict the prognosis of patients with multiple myeloma (bone marrow cancer) than traditional methods. The MMprofiler measures the activity of 92 genes which are directly or indirectly related to the […]
  • Flint Mobile swaps card reader for camera, accept mobile payments anywhere
    Flint Mobile, the swipe-free mobile payments app, has significantly expanded its payment management and loyalty capabilities for small, service-centric businesses, like the ones run by on-the-go medical equipment professionals. The toggle-free mobile technology makes the process quite simple for both parties, as all transactions are conducted through the mobile device’s camera without the need of any external […]
  • Should scientists be allowed to genetically alter human embryos?
    Scientists have at their disposal, a way to explore the possible prevention of genetic diseases before birth. But should they? Currently, the most promising path forward involves editing the genes of human embryos, a procedure threaded with controversy. An article in “Chemical & Engineering News” (C&EN), the weekly newsmagazine of the American Chemical Society (ACS), parses […]
  • Tackling chronic sinusitis by addressing underlying factors
    The stuffy noses and sinus pressure of head colds are uncomfortable, but for most people, they go away within days. For those with chronic sinusitis, however, those symptoms and others drag on for weeks. Now scientists are onto a potential new therapy that could address one of the underlying factors associated with the condition. They […]
  • Implantable “artificial pancreas” could help diabetes patients control their blood sugar
    Living with Type 1 diabetes requires constant monitoring of blood sugar levels and injecting insulin daily. Now scientists are reporting in the American Chemical Society (ACS) journal, “Industrial & Engineering Chemistry Research,” the development of an implantable “artificial pancreas” that continuously measures a person’s blood sugar or glucose level and can automatically release insulin as […]
  • Drug Deactivation program roll out to all facilities for safe disposal of unused prescription medications
    Verde Technologies announced that New Brighton-based Meridian Behavioral Health, the largest for-profit substance abuse and addiction treatment group in Minnesota, has become its most recent partner in the deactivation and safe disposal of prescription medications including methadone. Meridian is the first behavioral health group to roll out the Deterra Drug Deactivation System to all 17 […]
  • Lophius Biosciences introduces T-activated ImmunoScan Cocktail
    Lophius Biosciences announced the commercial launch of T-Track ImmunoScan and T-activated ImmunoScan Cocktail. Based on a proprietary and very specific cocktail of stimulants in combination with the Company’s T-activation technology, T-Track ImmunoScan and T-activated ImmunoScan Cocktail specifically target different cell types involved in both the adaptive and innate immune system. T-Track ImmunoScan and the T-activated […]

Leave a Reply